CDSCO Registration for Class A Medical Devices – Complete Guide Class A Non-Sterile & Non-Measuring Medical Device Registration

Q: Is CDSCO registration mandatory for Class A medical devices in India?

Yes, absolutely. While Class A non-sterile, non-measuring devices are exempt from licensing under MDR 2017, registration under Chapter IIIB is mandatory before any device can be sold, distributed, or imported in India. Skipping registration is a legal violation.

Q: What is the difference between CDSCO registration and a license for medical devices?

Registration (applicable to Class A non-sterile, non-measuring devices) is a simpler process involving basic documentation and self-declaration. Licensing (required for Class A sterile/measuring, B, C, and D devices) involves a more rigorous process including facility inspection, clinical data, and formal government approval. Registration does not equal licensing.

Q: How long does CDSCO Class A device registration take?

If all documents are complete and accurate, CDSCO typically processes Class A registrations within 30 to 45 working days. Incomplete applications or unanswered query letters can extend this timeline significantly.

Q: Can I sell a Class A medical device in India before receiving the registration certificate?

No. You must obtain the Registration Certificate from CDSCO before placing the device in the Indian market. Selling an unregistered device — even if it qualifies as Class A — is a violation of MDR 2017 and can attract penalties, seizure, or prosecution.

Q: Do I need ISO 13485 certification to register a Class A device?

ISO 13485 (Quality Management System for Medical Devices) is not strictly mandatory for Class A device registration. However, it is strongly recommended and is often requested during queries or audits. Having ISO 13485 can speed up the registration process and demonstrates quality compliance to buyers and hospitals.

Q: What if my device is not on the official Class A list?

If your medical device is not listed in the official CDSCO Class A list (Appendix A), you should not assume it is unregulated. It may fall under Class B, C, or D, or it may require classification guidance from CDSCO. You can raise a classification query with CDSCO's medical device division before filing any application.

Q: Can a foreign manufacturer register a Class A device directly with CDSCO?

No. Foreign manufacturers must appoint a valid Indian Authorized Agent (IAA) who is registered with CDSCO. The IAA applies on behalf of the foreign manufacturer and is the legally responsible party in India. All communications from CDSCO will go to the IAA.

Q: Is there any post-registration compliance requirement for Class A devices?

Class A devices are exempt from many post-market surveillance requirements. However, manufacturers and importers must maintain device records, ensure labels remain compliant, renew registration before expiry, and promptly inform CDSCO of any significant changes to the device or the company.

Q: Can one registration cover multiple variants of the same device?

Each distinct device (with a different intended use or product name as per the Class A list) generally requires a separate registration entry. However, minor variants of the same device (e.g., different sizes of the same surgical scissors) may sometimes be covered under one registration entry, depending on how the Class A list defines that device.

Q: What happens if my Class A device registration expires and I don't renew?

If your registration certificate expires and you continue to sell or distribute the device, you are technically operating with an unregistered device — which is a violation of MDR 2017. You may face market seizures, show-cause notices, or legal proceedings.

968+ devices classified as Class A Medical Devices — all exempt from licensing under MDR 2017
Manufacturers & importers must complete CDSCO online registration under Chapter IIIB
Lowest registration burden among all medical device classes in India — no clinical data required
Updated 2026: CDSCO portal now fully digital — apply, track, and renew registrations online

What is CDSCO Registration for Class A Medical Devices?

If you're a manufacturer, importer, or distributor of medical devices in India, chances are you've already come across the term CDSCO registration for Class A medical devices. But what exactly does it mean, and why does it matter so much in 2026?

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for medical devices, operating under the Ministry of Health and Family Welfare. Under the Medical Devices Rules (MDR), 2017, all medical devices sold in India are classified into four risk-based classes — A, B, C, and D — where Class A represents the lowest risk.

Here's the key point: Class A non-sterile and non-measuring medical devices are exempt from licensing under Chapters IV, V, VII, VIII, and XI of MDR 2017. However, they are NOT exempt from registration under Chapter IIIB. This distinction is critical — you still need to formally register these products with CDSCO before placing them on the Indian market.

Official Source: This guide is based on Appendix A of F. No. MED-16014(12)/1/2024-eoffice-Part(2) — the official CDSCO risk classification list for Class A non-sterile and non-measuring medical devices. The list contains 968+ approved device entries valid as of 2025–2026.

Medical Device Classification in India — A Quick Overview

Before diving deep into Class A registration, here's how CDSCO classifies all medical devices under MDR 2017:

Device Class	Risk Level & Regulatory Requirement
Class A (Non-Sterile, Non-Measuring)	Lowest risk. Registration required under Chapter IIIB. Exempt from licensing.
Class A (Sterile or Measuring)	Low risk with sterility/measurement requirements. Full licensing required.
Class B	Low to moderate risk. Manufacturing license + import license required.
Class C	Moderate to high risk. Clinical investigation data may be required.
Class D	Highest risk (life-sustaining, implantable). Strictest regulation, clinical evidence mandatory.

Bottom line: Class A non-sterile, non-measuring devices enjoy the simplest regulatory pathway in India. Registration is mandatory, but the process is significantly lighter compared to higher-risk classes.

Who Needs to Register Class A Medical Devices with CDSCO?

CDSCO registration under Chapter IIIB is required for:

Indian manufacturers producing Class A non-sterile, non-measuring medical devices for sale in India
Importers bringing Class A medical devices from foreign countries into India
Authorized agents or Indian representatives acting on behalf of foreign manufacturers
Contract manufacturers producing devices for third-party brands
Relabellers or repackagers of Class A devices

Important Note: Registration is NOT optional. Even though Class A devices are exempt from licensing, selling, distributing, or importing unregistered Class A devices in India is a legal violation under MDR 2017. CDSCO inspections and online verifications actively check registration status.

Eligibility Criteria for CDSCO Class A Device Registration

To be eligible for Class A device registration under CDSCO, the following conditions must be met:

Eligibility Criteria	Details
Device Type	Must be a non-sterile AND non-measuring medical device (as per official Class A list)
Intended Use Alignment	Device's intended use must match the CDSCO-approved description in the Class A list
Manufacturing Standards	ISO 13485 certification preferred; compliance with BIS standards where applicable
Legal Entity Status	Applicant must be a registered legal entity in India (company, LLP, proprietorship)
Foreign Manufacturers	Must appoint an Indian Authorized Agent (IAA) before applying
Device Not Already Notified	Device should not be already under a notified category requiring higher classification
No Prohibited Substances	Device must not incorporate drugs or biological materials that would require drug licensing

Complete List of Class A Non-Sterile, Non-Measuring Medical Devices (All 968+ Devices)

The table below contains the complete official CDSCO list of Class A non-sterile and non-measuring medical devices as per Appendix A of the CDSCO notification F. No. MED-16014(12)/1/2024. This is the master reference list used for determining whether your device qualifies for Class A registration.

How to use this table: Find your device by name in the list below. If your product appears here, it is classified as Class A (non-sterile, non-measuring) and qualifies for simple CDSCO registration — not full licensing. Use the device name and category to fill your registration application correctly.

S.No.	Medical Device Name	Device Category
1	Abdominal scissors, reusable	Surgical Instruments & Tools
2	Abdominal support/belt/binders, reusable	Patient Support & Hospital Furniture
3	Abdominal support/belt/binders, single use	Patient Support & Hospital Furniture
4	Abdominal/ENT/orthopaedic surgical probe, reusable	Surgical Instruments & Tools
5	Abrasive polishing agent	Dental & Oral Care Devices
6	Absorbent cotton wool, non- sterile	ENT Devices
8	Absorbent Underpad, non- antimicrobial	ENT Devices
9	Accupressure applicator, reusable	Surgical Instruments & Tools
10	Accupressure applicator, single-use	Surgical Instruments & Tools
11	Accupressure calf band	Other Class A Devices
12	Accupressure wristband	Orthopaedic & Mobility Devices
13	Acoustic chamber for audiometric testing	ENT Devices
14	Acoustic Stethoscope	ENT Devices
15	Adaptor, light source	Other Class A Devices
16	Adaptor, luer, non-sterile	Other Class A Devices
17	Adenotome blade, reusable	Surgical Instruments & Tools
18	Adenotome, reusable	Surgical Instruments & Tools
20	Adhesive pad for Transcutaneous electrical stimulation electrode	Wound Care & Dressings
21	Adhesive plaster (Zinc oxide adhesive plaster)/Tape	Wound Care & Dressings
22	Adhesive strip	Wound Care & Dressings
23	Adhesive tape remover	Wound Care & Dressings
24	Adult Incontinence Pants/Diaper	Incontinence & Hygiene Products
25	Aerosol adhesive for compression garments	Physiotherapy & Rehabilitation Devices
26	Air cushion/Pressure relief cushions	Other Class A Devices
27	Airway device cleaning utensil	Anaesthesia & Respiratory Accessories
28	Airway tube forceps, reusable	Anaesthesia & Respiratory Accessories
29	Alarm, bed occupancy	Patient Support & Hospital Furniture
30	Alcohol swab	Wound Care & Dressings
31	Alignment guide for orthopedic fixation	ENT Devices
32	Allergy testing adhesive strip, epicutaneous	Wound Care & Dressings
34	Alternating-pressure bed mattress overlay, reusable	Patient Support & Hospital Furniture
35	Alternating-pressure bed mattress overlay, single-use	Patient Support & Hospital Furniture
36	Ambulance stretcher loader	Patient Support & Hospital Furniture
37	Ambulance stretcher, electrohydraulic/pneumatic	Patient Support & Hospital Furniture
38	Ambulance stretcher, manual	Patient Support & Hospital Furniture
39	Amniotic membrane perforator, reusable	Surgical Instruments & Tools
40	Amsler grid	Ophthalmology Devices
42	Anaesthesia instrument table	ENT Devices
43	Anaesthesia mask stabilizer	Anaesthesia & Respiratory Accessories
44	Anaesthesia system leakage tester	Anaesthesia & Respiratory Accessories
45	Anaesthesia tube holder, non-sterile	Anaesthesia & Respiratory Accessories
46	Analytical non-scalp cutaneous electrode	Other Class A Devices
47	Analytical non-scalp cutaneous lead	Other Class A Devices
48	Anatomical model for surgical planning	Surgical Instruments & Tools
49	Aneurysm clip applier, reusable	Surgical Instruments & Tools
50	Ankle binder, reusable	Orthopaedic & Mobility Devices
51	Ankle cap	Orthopaedic & Mobility Devices
52	Ankle sleeves/brace	Orthopaedic & Mobility Devices
54	Ankle/foot orthosis	Orthopaedic & Mobility Devices
55	Anomaloscope	Ophthalmology Devices
56	Anterior chamber physical simulator	Other Class A Devices
57	Anterior wedge footwear/Off loading shoes	ENT Devices
58	Antiseptic generation system	Other Class A Devices
59	Anti-shock body support/Garment	Other Class A Devices
60	Anti-tremor gyroscopic orthotic glove	Other Class A Devices
61	Arm board pad	Wound Care & Dressings
62	Arm board, pediatric	Other Class A Devices
63	Arm sling	Other Class A Devices
64	Arm/leg procedure positioner padded strap	Wound Care & Dressings
65	Artificial airway stylet, reusable	Anaesthesia & Respiratory Accessories
67	Assistive coverall	Other Class A Devices
68	Assistive ergonomic chair	Patient Support & Hospital Furniture
69	Assistive ergonomic chair mobility base	Patient Support & Hospital Furniture
70	Assistive foot-propelled bicycle	Other Class A Devices
71	Assistive gripping/twisting tool, reusable	Other Class A Devices
72	Assistive mobility device, powered	Other Class A Devices
73	Assistive patient lifting pole	ENT Devices
74	Assistive shoes/boots	Other Class A Devices
76	Autopsy saw with/without vacuum filtration unit	Other Class A Devices
77	Autopsy/dissection table, mechanical/electric	Patient Support & Hospital Furniture
78	Back Support/Brace	Orthopaedic & Mobility Devices
79	Bagolini lens/Bagolini striated glasses	Ophthalmology Devices
80	Balance Board	Other Class A Devices
81	Bandage scissors, reusable	Wound Care & Dressings
82	Bariatric table/bed	Patient Support & Hospital Furniture
83	Basket stretcher	Patient Support & Hospital Furniture
84	Bath towelette	Other Class A Devices
85	Bed board	Patient Support & Hospital Furniture
87	Bed traction frame	Orthopaedic & Mobility Devices
88	Bedrail pad	Wound Care & Dressings
89	Bedside screen	Patient Support & Hospital Furniture
90	Binocular indirect lenses	Ophthalmology Devices
91	Binocular loupes	Ophthalmology Devices
92	Biohazard spill clean-up kit	Other Class A Devices
93	Birthing bath	Other Class A Devices
94	Birthing bed/table, non- powered	Patient Support & Hospital Furniture
95	Birthing bed/table, powered	Patient Support & Hospital Furniture
97	Bite block, dental, reusable	Dental & Oral Care Devices
98	Bite block, endoscopy, non- sterile	Dental & Oral Care Devices
99	Bite block, radiotherapy, non-sterile	Dental & Oral Care Devices
100	Bite registration rim wax	Dental & Oral Care Devices
101	Bite relief pad	Dental & Oral Care Devices
102	Bladder neck spreader, reusable	Orthopaedic & Mobility Devices
103	Blepharoplasty scissors, reusable	Surgical Instruments & Tools
104	Blood transfusion chair/couch	Patient Support & Hospital Furniture
105	Bobath table	Patient Support & Hospital Furniture
106	Body arch traction table	Orthopaedic & Mobility Devices
108	Bone curette, reusable	Surgical Instruments & Tools
109	Bone cutting forceps, reusable	Surgical Instruments & Tools
110	Bone distraction forceps, reusable	Orthopaedic & Mobility Devices
111	Bone file/rasp, manual, reusable	Surgical Instruments & Tools
112	Bone holding forceps, reusable	Surgical Instruments & Tools
113	Bone hook/ Bone retractor, reusable	Surgical Instruments & Tools
114	Bone nail driver, reusable	Surgical Instruments & Tools
115	Bone tap, reusable	Surgical Instruments & Tools
116	Bowl stand	Patient Support & Hospital Furniture
117	Box Wrench for Nut/Bolt, reusable	Other Class A Devices
118	Brachytherapy radionuclide phantom, test object	Other Class A Devices
120	Breast pump support kit, reusable	Other Class A Devices
121	Breathing circuit equipment dryer / drying chamber	ENT Devices
122	Bulldog clamp forceps/ Clamp manipulation forceps, reusable	Surgical Instruments & Tools
123	Cable-controlled external hand prosthesis	Orthopaedic & Mobility Devices
124	Camera for medical applications	Other Class A Devices
125	Canalith repositioning procedure chair, manual	Patient Support & Hospital Furniture
126	Capnography sampling adaptor	Other Class A Devices
127	Cardiac compression board	Physiotherapy & Rehabilitation Devices
129	Cardiopulmonary resuscitation mouthpiece/cover	Dental & Oral Care Devices
130	Cartilage knife/ Chondrotome, reusable	Surgical Instruments & Tools
131	Cast boot/shoes	Orthopaedic & Mobility Devices
132	Cast cutter vacuum system	Orthopaedic & Mobility Devices
133	Cast cutting scissors	Orthopaedic & Mobility Devices
134	Cast removal protective tape	Wound Care & Dressings
135	Cast stockinette	Orthopaedic & Mobility Devices
136	Cast walking heel	Orthopaedic & Mobility Devices
137	Cerebral Cavernous Malformations (CAM) vision stimulator	Ophthalmology Devices
139	Cervical cytology scraper, reusable	Other Class A Devices
140	Cervical pillow	Other Class A Devices
141	Cervical spine collar	Other Class A Devices
142	Cervical traction head holder/head halter	Orthopaedic & Mobility Devices
143	Cervical traction kit (with/without weights)	Orthopaedic & Mobility Devices
144	Cervical traction spreader bar/ Spreader bar	Orthopaedic & Mobility Devices
145	Cervicothoracic spine orthosis	Orthopaedic & Mobility Devices
146	Cervicothoracolumbosacral spine orthosis	Orthopaedic & Mobility Devices
147	Chair cushion, pediatric use	Patient Support & Hospital Furniture
148	Chair, flotation therapy	Patient Support & Hospital Furniture
149	Chemotherapy spill clean-up kit, non-sterile	Other Class A Devices
150	Chest stand	Patient Support & Hospital Furniture
152	Chisel/osteotome blade handle	Surgical Instruments & Tools
153	Cholera bed	Patient Support & Hospital Furniture
154	Cilia forceps	Surgical Instruments & Tools
155	Circumcision kit, reusable	Other Class A Devices
156	Clamp for rubber dam	Surgical Instruments & Tools
157	Clamp, reusable	Surgical Instruments & Tools
158	Clavicle support/brace/belt	Orthopaedic & Mobility Devices
159	Cleaning solution for medical devices	Other Class A Devices
160	Closed-ended intestinal ostomy bag, multiple-piece	Incontinence & Hygiene Products
161	Cold compression therapy cervical spine collar/ Ice collar	Physiotherapy & Rehabilitation Devices
163	Collar and cuff arm sling	Other Class A Devices
164	Colour discrimination non- prescription spectacles	Other Class A Devices
165	Colour discrimination tester	Other Class A Devices
166	Colour-discrimination eye chart	Ophthalmology Devices
167	Compression/pressure sock/stocking applicator	Physiotherapy & Rehabilitation Devices
168	Compression/pressure tubular garment	Physiotherapy & Rehabilitation Devices
169	Conductive abrasive gel for skin preparation, non-sterile	Other Class A Devices
170	Conductive electrode gel/paste (adhesive/non- adhesive), non-sterile	Other Class A Devices
171	Congenital hip dislocation abduction splint	Orthopaedic & Mobility Devices
172	Contact lens inserter/remover, non-sterile	Ophthalmology Devices
173	Controlled ankle motion (CAM) walker	Orthopaedic & Mobility Devices
174	Corn/callus dressing, reusable	Wound Care & Dressings
176	Cotton and rubber elastic bandage	Wound Care & Dressings
177	Cotton crepe bandage	Wound Care & Dressings
178	Cottonoid pad, non-sterile	Wound Care & Dressings
179	Cover for thermometer probe, non-sterile	Surgical Instruments & Tools
180	CPAP/BPAP chin strap, reusable	Other Class A Devices
181	CPAP/BPAP chin strap,single use	Other Class A Devices
182	CPAP/BPAP unit ambient air filter	ENT Devices
183	Cranial trephine, reusable	Other Class A Devices
184	Craniofacial rongeur, reusable	Surgical Instruments & Tools
186	Crutches	Orthopaedic & Mobility Devices
187	CT phantom, test object	Other Class A Devices
188	Cystoscopic rongeur, reusable	Surgical Instruments & Tools
189	Cytotoxic waste receptacle	Other Class A Devices
190	Dappen dish, reusable	Other Class A Devices
191	Dappen dish, single-use	Other Class A Devices
192	Denis Brown splint	Orthopaedic & Mobility Devices
193	Dental abrasive disk guard	Dental & Oral Care Devices
194	Dental abrasive disk, reusable	Dental & Oral Care Devices
195	Dental abrasive disk, single- use	Dental & Oral Care Devices
197	Dental abrasive strip, single- use	Dental & Oral Care Devices
198	Dental amalgam mixer	Dental & Oral Care Devices
199	Dental articulation liquid	Dental & Oral Care Devices
200	Dental articulation paper	Dental & Oral Care Devices
201	Dental articulation paper forceps	Dental & Oral Care Devices
202	Dental automated x-ray film processor	Dental & Oral Care Devices
203	Dental camera cover, non- sterile	Dental & Oral Care Devices
204	Dental cheek retractor, home-use	Dental & Oral Care Devices
205	Dental cheek retractor, professional	Dental & Oral Care Devices
206	Dental cotton roll, non-sterile	Dental & Oral Care Devices
208	Dental dressing forceps, reusable	Dental & Oral Care Devices
209	Dental elevator, sinus lift, reusable	ENT Devices
210	Dental elevator, tooth/root, reusable	Dental & Oral Care Devices
211	Dental examination kit, reusable	Dental & Oral Care Devices
212	Dental excavator, reusable	Dental & Oral Care Devices
213	Dental float/rasp, manual (for veterinary use)	Dental & Oral Care Devices
214	Dental floss	Dental & Oral Care Devices
215	Dental handpiece cover, non-sterile	Dental & Oral Care Devices
216	Dental implant abutment analog, laboratory	ENT Devices
218	Dental implant abutment trial	ENT Devices
219	Dental implant extractor, reusable	Dental & Oral Care Devices
220	Dental implant/prosthesis handling forceps, reusable	Dental & Oral Care Devices
221	Dental impression adhesive	Dental & Oral Care Devices
222	Dental impression material	Dental & Oral Care Devices
223	Dental impression material kit, reusable	Dental & Oral Care Devices
224	Dental impression material kit, single-use	Dental & Oral Care Devices
225	Dental impression material mixer	Dental & Oral Care Devices
226	Dental impression material syringe	Dental & Oral Care Devices
228	Dental impression tray material	Dental & Oral Care Devices
229	Dental impression tray, reusable	Dental & Oral Care Devices
230	Dental irrigation/aspiration syringe, reusable	Dental & Oral Care Devices
231	Dental laboratory bur, reusable	Dental & Oral Care Devices
232	Dental laboratory curing light	Dental & Oral Care Devices
233	Dental material application tool, reusable	Dental & Oral Care Devices
234	Dental material heater	Dental & Oral Care Devices
235	Dental material mixing nozzle, non-sterile	Dental & Oral Care Devices
236	Dental material mixing surface, reusable	Dental & Oral Care Devices
238	Dental matrix band, reusable	Dental & Oral Care Devices
239	Dental matrix band, single- use, non-sterile	Dental & Oral Care Devices
240	Dental matrix wedge	Dental & Oral Care Devices
241	Dental precision attachment fitting/adjustment tool, reusable	ENT Devices
242	Dental prosthesis/implant abutment screw analog, reusable/ Guide pin, reusable	ENT Devices
243	Dental resin applicator	Dental & Oral Care Devices
244	Dental rongeur, reusable	Dental & Oral Care Devices
245	Dental rubber dam clamp forceps, reusable	Dental & Oral Care Devices
246	Dental rubber dam, non- sterile	Dental & Oral Care Devices
248	Dental spatula	Dental & Oral Care Devices
249	Dental suction protective mouthpiece	Dental & Oral Care Devices
250	Dental suction system fluid- separation unit	Dental & Oral Care Devices
251	Dental surgical microscope	Dental & Oral Care Devices
252	Dental surgical probe, reusable	Dental & Oral Care Devices
253	Dental torque wrench adaptor	Dental & Oral Care Devices
254	Dental wedge (for veterinary use)	Dental & Oral Care Devices
255	Dental X-ray beam aligner	Dental & Oral Care Devices
256	Dental X-ray film holder	Dental & Oral Care Devices
257	Dental/oral lavage unit (water flosser)	Dental & Oral Care Devices
259	Dentifrice/ Dental polishing paste	Dental & Oral Care Devices
260	Dentures cup	Other Class A Devices
261	Dermatome skin approximation tape	Wound Care & Dressings
262	Dermatome, manual, reusable	Other Class A Devices
263	Dermatoscope, digital	Other Class A Devices
264	Derotation bar with Traction	Orthopaedic & Mobility Devices
265	Diagnostic condensing lens	Ophthalmology Devices
266	Diagnostic X-ray system positioning frame	Imaging & Radiology Accessories
267	Diagnostic x-ray tube mount	Imaging & Radiology Accessories
268	Dialysis bag clamp/clip	Surgical Instruments & Tools
269	Dialysis set holder	Other Class A Devices
270	Diaphragm wearable urinal	ENT Devices
271	Digital examination camera	Other Class A Devices
272	Direct ophthalmoscope eye cup	Ophthalmology Devices
273	Disposable Kelly pad	Wound Care & Dressings
275	Douche kit	Other Class A Devices
276	Drape adhesive	Other Class A Devices
277	Draping incontinence liner	Incontinence & Hygiene Products
278	Dressing retention garments	Wound Care & Dressings
279	Dressing trolley	Wound Care & Dressings
280	Dressing/utility forceps, reusable	Wound Care & Dressings
281	Drip wearable urinal	ENT Devices
282	Driver/extractor, reusable	Other Class A Devices
283	Dry powder inhaler	Other Class A Devices
284	Dry salt therapy device	Other Class A Devices
285	Ear bowl	ENT Devices
287	Ear canal light	ENT Devices
288	Ear hook, reusable	ENT Devices
289	Ear Irrigation kit	ENT Devices
290	Ear speculum, reusable / Ear cannula, reusable	ENT Devices
291	Earmould impression kit	ENT Devices
292	Earmould impression material	ENT Devices
293	Elastic adhesive Bandage	Wound Care & Dressings
294	Elasticated cohesive Bandage	Wound Care & Dressings
295	Elbow immobilizer	Orthopaedic & Mobility Devices
296	Elbow orthosis	Orthopaedic & Mobility Devices
298	Electric linear actuator with/without control box	ENT Devices
299	Electric stander	Patient Support & Hospital Furniture
300	Electric toothbrush	Dental & Oral Care Devices
301	Electrical-only medical device connection adaptor	Other Class A Devices
302	Electrical-only medical device connection cable, reusable	Other Class A Devices
303	Electrode/transducer strap, reusable	Other Class A Devices
304	Electronic occlusion spectacles	Other Class A Devices
305	Electrosurgical electrode holder	Surgical Instruments & Tools
306	Elevator, ear/nose/throat	ENT Devices
308	Elevator, orthopaedic/ Bone lever/elevator, reusable	Surgical Instruments & Tools
309	Elevator, uterine	Surgical Instruments & Tools
310	Emesis bag	Other Class A Devices
311	Endaural wax extraction curette	Orthopaedic & Mobility Devices
312	Endodontic plugger, reusable	Dental & Oral Care Devices
313	Endoscope calibration cover, reusable	Other Class A Devices
314	Endoscope camera adaptor/coupler, reusable	Other Class A Devices
316	Endoscope channel cleaning valve	Other Class A Devices
317	Endoscope cleaning brush	Other Class A Devices
318	Endoscope collector	Other Class A Devices
319	Endoscope flushing adaptor	Other Class A Devices
320	Endoscope leak tester tubing	Patient Support & Hospital Furniture
321	Endoscope Storage Cabinet	Patient Support & Hospital Furniture
322	Endoscope/instrument holder, noninvasive, manually-adjusted	ENT Devices
323	Endoscopic biopsy valve, reusable	Surgical Instruments & Tools
324	Endoscopic irrigation/aspiration foot- pedal	Other Class A Devices
326	Endotracheal tube holder	Anaesthesia & Respiratory Accessories
327	Endotracheal tube introducer, reusable	Other Class A Devices
328	Enema bag	Other Class A Devices
329	Enema tip, reusable	Other Class A Devices
330	Enema tube, non-sterile	Other Class A Devices
331	ENT chair, electric without operative unit	ENT Devices
332	ENT chair, mechanical without operative unit	ENT Devices
333	ENT foreign body extraction forceps, reusable	ENT Devices
334	ENT illuminating foreign body extraction set	ENT Devices
336	ENT Nasal snare, reusable	ENT Devices
337	ENT speculum holder	ENT Devices
338	ENT surgical excavator, reusable	ENT Devices
339	ENT surgical microscope	ENT Devices
340	ENT transilluminator	ENT Devices
341	Enteral feeding/decompression tube clearing stem	ENT Devices
342	Enteric stomal shield	Other Class A Devices
343	Enuresis alarm/ Incontinence sensor	Incontinence & Hygiene Products
344	Epileptic seizure alarm	Other Class A Devices
346	Extension Plaster –width wise stretchable	Wound Care & Dressings
347	External arm prosthesis socket	Orthopaedic & Mobility Devices
348	External arm prosthesis, pediatric, non-powered	Orthopaedic & Mobility Devices
349	External asembled lower limb prosthesis	Orthopaedic & Mobility Devices
350	External limb orthotic component	Other Class A Devices
351	External limb prosthesis socket liner	Orthopaedic & Mobility Devices
352	External limb prosthetic component	Other Class A Devices
353	External lower-limb prosthesis socket	Orthopaedic & Mobility Devices
354	External nasal splint	ENT Devices
355	External silicone breast prosthesis	Orthopaedic & Mobility Devices
356	Extractor, reusable	Other Class A Devices
358	Eye heat therapy mask, self- heating, single-use	Ophthalmology Devices
359	Eye irrigation shield	Ophthalmology Devices
360	Eye pad, non sterile	Ophthalmology Devices
361	Eye patch, non-sterile	Ophthalmology Devices
362	Eyelid clamp, reusable	Ophthalmology Devices
363	Eyelid speculum, reusable	Ophthalmology Devices
364	Eyelid weight, external	Ophthalmology Devices
365	Face shield	Other Class A Devices
366	Feeding nipple	Other Class A Devices
367	Felt tangent screen	ENT Devices
369	Fiber cast bandage	Wound Care & Dressings
370	Fibreoptic general-purpose ophthalmic hook, reusable	Ophthalmology Devices
371	Fibreoptic vaginal speculum	Ophthalmology Devices
372	Filter adapter (Spirometry accessory)	Other Class A Devices
373	Filter for dental suction equipment	Dental & Oral Care Devices
374	Filter for gas central supply system	Other Class A Devices
375	Finger and toe bandage	Wound Care & Dressings
376	Finger Cot/brace	Orthopaedic & Mobility Devices
378	Finger/hand exerciser	Physiotherapy & Rehabilitation Devices
379	Finger/thumb prosthesis	Orthopaedic & Mobility Devices
380	Fistula hook, reusable	Surgical Instruments & Tools
381	Fistula probe, reusable	Surgical Instruments & Tools
382	Flatus tube, reusable	Other Class A Devices
383	Flex bar	Other Class A Devices
384	Flieringa ophthalmic ring	Ophthalmology Devices
385	Flotation therapy bed, neonatal	Patient Support & Hospital Furniture
386	Fluid delivery mount, general-purpose	Other Class A Devices
387	Fluted surgical drill bit, reusable	Surgical Instruments & Tools
389	Footstool, conductive	Other Class A Devices
390	Forceps jar	Surgical Instruments & Tools
391	Forceps, biopsy/Open- surgery biopsy forceps, reusable	Surgical Instruments & Tools
392	Forceps, bone, reusable	Surgical Instruments & Tools
393	Forceps, dental, reusable	Dental & Oral Care Devices
394	Forceps, dissecting, tweezers/scissors-like, reusable	Surgical Instruments & Tools
395	Forceps, dressing	Wound Care & Dressings
396	Forceps, ear/nose/throat/ENT forceps, reusable	ENT Devices
398	Forceps, general-purpose	Surgical Instruments & Tools
399	Forceps, gynaecological/Gynaecologic al grasping forceps, reusable	Surgical Instruments & Tools
400	Forceps, haemostatic, reusable	Surgical Instruments & Tools
401	Forceps, intestinal, reusable	Surgical Instruments & Tools
402	Forceps, kidney, reusable	Surgical Instruments & Tools
403	Forceps, obstetric, general- purpose, reusable	Surgical Instruments & Tools
404	Forceps, sterilizer transfer	Surgical Instruments & Tools
405	Forceps, stone removal/Open-surgery stone-retrieval forceps, reusable	Surgical Instruments & Tools
407	Forceps, wire/Wire holding/twisting forceps, reusable	Surgical Instruments & Tools
408	Fornixscope	Other Class A Devices
409	Freestanding patient lifting system, electric	ENT Devices
410	Freestanding patient lifting system, manual	ENT Devices
411	Fresnel lens	Ophthalmology Devices
412	Fresnel prism	Other Class A Devices
413	Fundus camera	Other Class A Devices
414	Fundus camera, pediatric	Other Class A Devices
416	Gait Trainer, non-powered	Other Class A Devices
417	Gas cylinder trolley	Patient Support & Hospital Furniture
418	Gas sampling line filter, reusable	Other Class A Devices
419	Gastric pH strip	Other Class A Devices
420	Gastrointestinal ostomy tube pocket	Incontinence & Hygiene Products
421	Gel base for metallic neuro head frame	Other Class A Devices
422	Gel knee ring	Orthopaedic & Mobility Devices
423	Gel-filled bed mattress	Patient Support & Hospital Furniture
425	Gel-filled chair cushion	Patient Support & Hospital Furniture
426	General external orthopaedic fixation kit, reusable	Other Class A Devices
427	General internal orthopaedic fixation system implantation kit, reusable, non-measuring	Other Class A Devices
428	General-gas low pressure tubing, reusable	Patient Support & Hospital Furniture
429	General-purpose curette, reusable	Surgical Instruments & Tools
430	General-purpose diagnostic x-ray phantom, anthropomorphic	Imaging & Radiology Accessories
432	General-purpose manually- operated operation table	Patient Support & Hospital Furniture
433	General-purpose patient lifting system sling/harness	ENT Devices
434	General-purpose surgical spatula, reusable	Surgical Instruments & Tools
435	General-purpose diagnosis/treatment table	ENT Devices
436	Gingival barrier (non- medicated)	Dental & Oral Care Devices
437	Gonadal radiation protector	Imaging & Radiology Accessories
438	Gonio lens/ Gonioscope	Ophthalmology Devices
439	Gravity enema set, non- sterile	Other Class A Devices
440	Grip-enhancing exoskeleton	Other Class A Devices
441	Gynaecological bib	Other Class A Devices
442	Gynaecological biopsy forceps, reusable	Surgical Instruments & Tools
443	Gynaecological operating table top	Patient Support & Hospital Furniture
445	Gynaecological polypectomy forceps	Surgical Instruments & Tools
446	Gynaecological surgical microscope	Surgical Instruments & Tools
447	Gynaecological examination/treatment table	ENT Devices
448	Gynecological couch (examination table)	Patient Support & Hospital Furniture
449	Haemodialysis chair, electrically powered/Manual	Patient Support & Hospital Furniture
450	Haidinger brush imager	Other Class A Devices
451	Hallux valgus metatarsophalangeal orthosis	Orthopaedic & Mobility Devices
452	Hand exerciser table	Physiotherapy & Rehabilitation Devices
453	Hand/finger splint	Orthopaedic & Mobility Devices
454	Hand-carried stretcher	Patient Support & Hospital Furniture
455	Handgrip cover for laryngoscope	ENT Devices
456	Handgrip cover for surgical light	Surgical Instruments & Tools
457	Handgrip cover for vein illumination device	Other Class A Devices
459	Hand-held surgical retractor, reusable	Surgical Instruments & Tools
460	Hand-held telescope	Other Class A Devices
461	Hand-held urinal, female, reusable	Other Class A Devices
462	Hand-held urinal, male, reusable	Other Class A Devices
463	Head marking cap	Other Class A Devices
464	Head reflector	Other Class A Devices
465	Head Rest/Ring	Other Class A Devices
466	Heal cushion/Spur pad/cup	Wound Care & Dressings
467	Heat therapy gel	Physiotherapy & Rehabilitation Devices
468	Heat-sealing device	Other Class A Devices
470	Hip pad positioning device	Wound Care & Dressings
471	Hip prosthesis socket pusher	Orthopaedic & Mobility Devices
472	Hip protector (Belt)	Orthopaedic & Mobility Devices
473	Hip shield	Orthopaedic & Mobility Devices
474	Hoof knife	Surgical Instruments & Tools
475	Hoof trimmer/puller	Other Class A Devices
476	Hook, intrauterine device removal	Surgical Instruments & Tools
477	Hook, surgical, general- purpose	Surgical Instruments & Tools
478	Hook, surgical, gynaecological, fibroid	Surgical Instruments & Tools
479	Hook, surgical, rhinoplasty, reusable	Surgical Instruments & Tools
480	Hook, surgical, skin, reusable	Surgical Instruments & Tools
482	Hook, surgical, tracheal	Surgical Instruments & Tools
483	Horizontal non-powered traction system	Orthopaedic & Mobility Devices
484	Hospital Backrest	Patient Support & Hospital Furniture
485	Hospital bed remote control (hand-operated/foot operated)	Patient Support & Hospital Furniture
486	Hospital Bedside cabinet	Patient Support & Hospital Furniture
487	Hospital Linen trolley	Patient Support & Hospital Furniture
488	Hot/cold therapy pack, reusable	Physiotherapy & Rehabilitation Devices
489	Hruby fundus lens	Ophthalmology Devices
490	Hydraulic/pneumatic external knee prosthesis	Orthopaedic & Mobility Devices
491	Hydrophilic wound dressing, non-sterile	Wound Care & Dressings
493	Ice bag	Other Class A Devices
494	ICU Bed, mechanical/electric	Patient Support & Hospital Furniture
495	Image display monitor mount	Other Class A Devices
496	Incentive spirometer	Other Class A Devices
497	Incontinence device suspender	Incontinence & Hygiene Products
498	Incontinence penis clamp, reusable	Incontinence & Hygiene Products
499	Indirect binocular ophthalmoscope	Ophthalmology Devices
500	Infant acoustic earmuffs, ENT	ENT Devices
501	Infant CPAP stabilizing cap/strap	Other Class A Devices
503	Infant incubator warming hood	Other Class A Devices
504	Infant inguinal hernia truss	Other Class A Devices
505	Infant limb immobilizer, reusable	Other Class A Devices
506	Infant limb immobilizer, single- use	Other Class A Devices
507	Infant oral pacifier	Dental & Oral Care Devices
508	Infant resuscitation cabinet	Patient Support & Hospital Furniture
509	Infant resuscitation table	Patient Support & Hospital Furniture
510	Infant sleep positioner/ Infant positioning aid	Other Class A Devices
511	Infant whole-body immobilizer, reusable	Other Class A Devices
513	Infant-hammock bed mattress	Patient Support & Hospital Furniture
514	Infant-hammock bed mattress overlay	Patient Support & Hospital Furniture
515	Inflatable limb splint	Orthopaedic & Mobility Devices
516	Inflatable patient transfer sliding mattress	ENT Devices
517	Infusion line clamp	Surgical Instruments & Tools
518	Infusion line securement clip, single-use	ENT Devices
519	Inguinal hernia belt (Adult)/surgical truss, reusable	Surgical Instruments & Tools
520	Inguinal hernia belt (Adult)/surgical truss, singe use	Surgical Instruments & Tools
521	Injection site desensitizer, tactile	Other Class A Devices
522	In-line backflow valve, reusable	Other Class A Devices
524	Integration Unit for Flat panel x-ray detector	Imaging & Radiology Accessories
525	Internal spinal fixation procedure kit, reusable	Orthopaedic & Mobility Devices
526	Intestinal ostomy base plate	Incontinence & Hygiene Products
527	Intestinal ostomy support kit	Incontinence & Hygiene Products
528	Intestinal stoma shield/support belt	Other Class A Devices
529	Intraoperative chest positioner	Other Class A Devices
530	Intraoral camera	Dental & Oral Care Devices
532	Intraoral-scanning analog for dental implant abutment	Dental & Oral Care Devices
533	Intravenous access monitoring system, line- disconnection	Other Class A Devices
534	Intravenous catheter holder, non-sterile	Incontinence & Hygiene Products
535	Intravenous hanger	Other Class A Devices
536	Intubation laryngoscope, reusable	ENT Devices
537	Intubation teeth protector	Dental & Oral Care Devices
538	Inversion table, physiotherapy	Physiotherapy & Rehabilitation Devices
540	Isolation gown, reusable	Other Class A Devices
541	Jaw exerciser, non-powered	Physiotherapy & Rehabilitation Devices
542	Joint/spinal manipulator, mechanical, reusable	Orthopaedic & Mobility Devices
543	Kidney tray/Cidex tray	Other Class A Devices
544	Kinesiology tape	Wound Care & Dressings
545	Kinetic bed	Patient Support & Hospital Furniture
546	Knee cap/brace/wrap	Orthopaedic & Mobility Devices
547	Knee ice wrap	Orthopaedic & Mobility Devices
548	Knife handle/ Scalpel handle, reusable	Surgical Instruments & Tools
549	Knife sharpener	Surgical Instruments & Tools
551	Laminar Air Flow/ Biosafety cabinet (BSL I)	Patient Support & Hospital Furniture
552	Laparoscope laser adaptor	Other Class A Devices
553	Laparoscopic surgery handle	Other Class A Devices
554	Laparoscopic tray	Other Class A Devices
555	Laryngeal airway introducer, reusable	Anaesthesia & Respiratory Accessories
556	Laryngeal knife, reusable	Surgical Instruments & Tools
557	Laryngeal mirror, reusable	Other Class A Devices
558	Laryngoscope blade, reusable	ENT Devices
560	Lens system, Ophthalmology, high magnification	Ophthalmology Devices
561	Lifting column with/without control box	Other Class A Devices
562	Ligament reconstruction instrument set, reusable	ENT Devices
563	Light beam patient position indicator	ENT Devices
564	Limb/torso/head restraint, reusable	Other Class A Devices
565	Liquid crystal vein locator	Other Class A Devices
566	Lower limb exerciser, non- measuring	Physiotherapy & Rehabilitation Devices
567	Lower limb sliding exerciser, non-powered	Physiotherapy & Rehabilitation Devices
568	Lower-limb orthosis	Orthopaedic & Mobility Devices
569	Lower-limb warming sock/stocking	Other Class A Devices
571	Magnetic field shielding material for cochlear implants	ENT Devices
572	Mammographic x-ray phantom, test object	Imaging & Radiology Accessories
573	Mammographic x-ray system compression paddle	Wound Care & Dressings
574	Mandible-repositioning sleep-disordered breathing/ Anti-snoring orthosis	Anaesthesia & Respiratory Accessories
575	Mandible-repositioning/ palate-lifting sleep- disordered breathing/ Anti- snoring orthosis	Anaesthesia & Respiratory Accessories
576	Manual dental burnisher, reusable	Dental & Oral Care Devices
577	Manual dental torque wrench, reusable	Dental & Oral Care Devices
579	Manual dexterity test	Other Class A Devices
580	Manual endodontic filling material spreader	Dental & Oral Care Devices
581	Manual general-purpose hospital bed	Patient Support & Hospital Furniture
582	Manual non-rotary dental instrument handle	ENT Devices
583	Manual orthopaedic bender, reusable	Other Class A Devices
584	Manual orthopedic cement extractor, reusable	ENT Devices
585	Manual patient lifting belt/harness	ENT Devices
586	Manual scalpel blade, reusable	Surgical Instruments & Tools
588	Manual toothbrush	Dental & Oral Care Devices
589	Manual wheeled stretcher	Patient Support & Hospital Furniture
590	Manual-aperture-control diagnostic x-ray system collimator, non-motorized	Imaging & Radiology Accessories
591	Marker, dental use	Dental & Oral Care Devices
592	Mask strap	Anaesthesia & Respiratory Accessories
593	Massage table/couch	Physiotherapy & Rehabilitation Devices
594	Mastoid chisel, reusable	Surgical Instruments & Tools
595	Maternity belt	Other Class A Devices
596	Maternity pad	Wound Care & Dressings
597	Mattress for hospital bed	Patient Support & Hospital Furniture
598	Mechanical dental chair without operative unit	Dental & Oral Care Devices
600	Mechanical-resistance external ankle-foot prosthesis	Orthopaedic & Mobility Devices
601	Mechanical-resistance external knee prosthesis	Orthopaedic & Mobility Devices
602	Mechatronic external ankle- foot prosthesis	Orthopaedic & Mobility Devices
603	Medical bowl	Other Class A Devices
604	Medical compression stockings	Physiotherapy & Rehabilitation Devices
605	Medical Equipment/instrument drape, reusable	ENT Devices
606	Medical Equipment/instrument drape, single-use, non-sterile	ENT Devices
607	Medical examination gloves, latex/non latex, non-sterile	Other Class A Devices
608	Medical examination light (AC powered or Battery)	Other Class A Devices
609	Medical image printer	Other Class A Devices
611	Medical imaging recorder	Imaging & Radiology Accessories
612	Medical Instrument cabinet	ENT Devices
613	Medical instrument cable/lead	ENT Devices
614	Medical instrument lubricant	ENT Devices
615	Medical Laser protection/safety eyewear	Ophthalmology Devices
616	Medical print paper	Other Class A Devices
617	Medical support stocking	Other Class A Devices
618	Medical x-ray film, non- screen	Imaging & Radiology Accessories
619	Medical/cadaver body bags, non sterile	Other Class A Devices
620	Medical/Orthotic insoles	Other Class A Devices
622	Medicine cup	Other Class A Devices
623	Medicine trolley	Patient Support & Hospital Furniture
624	Meibomian gland camera	Other Class A Devices
625	Meibomian gland expressor/evaluator, manual	Other Class A Devices
626	Metatarsal pad	Wound Care & Dressings
627	Microporous medical tape	Wound Care & Dressings
628	Microscope cover	Other Class A Devices
629	Middle ear chisel, reusable	ENT Devices
630	Middle ear malleus nipper/ hook/anvil, reusable	ENT Devices
631	Middle ear pick, reusable	ENT Devices
633	Mobile patient lifting system, electric	ENT Devices
634	Mobile patient lifting system, manual	ENT Devices
635	Mobile radiation protection barrier	Imaging & Radiology Accessories
636	Moist-cold pack	Other Class A Devices
637	Moist-cold pressure bandage	Wound Care & Dressings
638	Moldable splint	Orthopaedic & Mobility Devices
639	Mortuary trolley, mechanical/hydraulic/electric	Patient Support & Hospital Furniture
640	Motorized diagnostic imaging view box	Imaging & Radiology Accessories
641	Mouth gag	Dental & Oral Care Devices
642	Mouth speculum/ Mouth gag (for veterinary use)	Dental & Oral Care Devices
644	MRI examination catheter holder	Imaging & Radiology Accessories
645	MRI phantom, test object	Imaging & Radiology Accessories
646	MRI system chair	Imaging & Radiology Accessories
647	Multi-chamber venous compression system garment	Physiotherapy & Rehabilitation Devices
648	Multi-modality therapeutic radiation phantom, test object	Imaging & Radiology Accessories
649	Multiple spinal region orthosis	Orthopaedic & Mobility Devices
650	Nail splitting scissors, reusable	Surgical Instruments & Tools
651	Nappy changing table, portable	Patient Support & Hospital Furniture
652	Nasal aspirator, electric	ENT Devices
654	Nasal chisel, reusable	ENT Devices
655	Nasal dilator	ENT Devices
656	Nasal Irrigation kit	ENT Devices
657	Nasal irrigation kit, pediatric	ENT Devices
658	Nasal scissors, reusable	ENT Devices
659	Nasal septum straightening forceps	ENT Devices
660	Nasal speculum, reusable	ENT Devices
661	Nasogastric tube holder, intranasal, short-term use	ENT Devices
662	Nasogastric tube holder, non-sterile	Anaesthesia & Respiratory Accessories
663	Needle guard	Other Class A Devices
665	Needle/Syringe cutter	Other Class A Devices
666	Neonatal eye pad	Ophthalmology Devices
667	Neonatal kangaroo care garment	Other Class A Devices
668	Nerve/vessel retractor/hook, reusable	Surgical Instruments & Tools
669	Neuro Pinwheel	Other Class A Devices
670	Neurosurgical chair	Patient Support & Hospital Furniture
671	Neurosurgical headrests	Surgical Instruments & Tools
672	Newborn-infant bed	Patient Support & Hospital Furniture
673	Nipple pad/ring, reusable	Wound Care & Dressings
674	Nipple prosthesis, external	Orthopaedic & Mobility Devices
675	Nipple shield	Other Class A Devices
676	Non-antimicrobial postsurgical brassiere	Surgical Instruments & Tools
678	Non-powered accelerator system table	Patient Support & Hospital Furniture
679	Nonpowered flotation therapy mattress	Patient Support & Hospital Furniture
680	Non-powered neutron therapy table	Patient Support & Hospital Furniture
681	Non-powered remote irradiation therapy table	Imaging & Radiology Accessories
682	Non-powered X-rays radiation therapy table	Imaging & Radiology Accessories
683	Non-sterile Hemostatic clip applier	Other Class A Devices
684	Nose clip	ENT Devices
685	Nose clip (Spirometry accessory)	ENT Devices
686	Nuclear scanning bed/table	ENT Devices
687	Nuclear sealed calibration source	ENT Devices
688	Nystagmus inducing optokinetic drum	Other Class A Devices
689	Nystagmus inducing tape	Wound Care & Dressings
690	One-piece urostomy bag, non-sterile	Incontinence & Hygiene Products
692	OPD Patient couch/chair	ENT Devices
693	Operating room shoes cover, non-sterile	Other Class A Devices
694	Operating table traction frame	Orthopaedic & Mobility Devices
695	Operation theatre pendant	Other Class A Devices
696	Operator radiation protection spectacles	Imaging & Radiology Accessories
697	Ophthalmic equipment stand	Ophthalmology Devices
698	Ophthalmic head reflector	Ophthalmology Devices
699	Ophthalmic implant handling forceps, reusable	Ophthalmology Devices
700	Ophthalmic operating table top	Ophthalmology Devices
701	Ophthalmic surgery fluid collection bag	Ophthalmology Devices
703	Ophthalmic suture scissors, reusable	Ophthalmology Devices
704	Ophthalmic Trial frame	Ophthalmology Devices
705	Ophthalmoleukoscope	Ophthalmology Devices
706	Opthalmic examintaion station, without surgical unit	Surgical Instruments & Tools
707	Oral care swab	Dental & Oral Care Devices
708	Oral exerciser, Physiotherapy	Dental & Oral Care Devices
709	Orbital depressor, reusable	Other Class A Devices
710	Oropharyngeal airway, reusable	ENT Devices
711	Orthodontic aligner/retainer seater	Other Class A Devices
712	Orthodontic band pusher	Other Class A Devices
713	Orthodontic elastomeric appliance pusher	Other Class A Devices
715	Orthodontic positioner support kit	Other Class A Devices
716	Orthodontic resin positioning tray	Other Class A Devices
717	Orthodontic vibrator	Other Class A Devices
718	Orthopaedic bone pin holder	Surgical Instruments & Tools
719	Orthopaedic bone-fragment manipulator, reusable	ENT Devices
720	Orthopaedic bone-reduction tool, reusable	Surgical Instruments & Tools
721	Orthopaedic broach, reusable	Other Class A Devices
722	Orthopaedic chisel blade, reusable	Surgical Instruments & Tools
723	Orthopaedic chisel, reusable	Surgical Instruments & Tools
725	Orthopaedic fixation plate tensioner, reusable	Physiotherapy & Rehabilitation Devices
726	Orthopaedic implant driver, reusable	Other Class A Devices
727	Orthopaedic implant impactor, reusable	Other Class A Devices
728	Orthopaedic implantable- device cutter, reusable	Patient Support & Hospital Furniture
729	Orthopaedic instrument extractor, reusable	ENT Devices
730	Orthopaedic joint/limb rongeur, reusable	Surgical Instruments & Tools
731	Orthopaedic osteotome blade, reusable	Surgical Instruments & Tools
732	Orthopaedic osteotome, reusable	Surgical Instruments & Tools
734	Orthopaedic traction bed	Orthopaedic & Mobility Devices
735	Orthopedic cast padding	Wound Care & Dressings
736	Orthopedic implantation sleeve, reusable	Other Class A Devices
737	Orthopedic Reamer handle, reusable	Other Class A Devices
738	Orthopedic Reamer, reusable	Other Class A Devices
739	Orthopedic rod reducer/cutter, reusable	Other Class A Devices
740	Orthopedic Spatula, reusable	Other Class A Devices
742	Ostomy adhesive	Incontinence & Hygiene Products
743	Otoscope cover, non-sterile	ENT Devices
744	Otoscope, direct	ENT Devices
745	Oxygen administration hood	Anaesthesia & Respiratory Accessories
746	Oxygen administration hood, paediatric	Anaesthesia & Respiratory Accessories
747	Oxygen administration tent, neonatal/paediatric	Anaesthesia & Respiratory Accessories
748	Oxygen mask respiration indicator	Anaesthesia & Respiratory Accessories
749	Pacemaker test magnet	Other Class A Devices
750	Packer, gauze	Wound Care & Dressings
751	Paediatric bed	Patient Support & Hospital Furniture
753	Paediatric dental chair, mechanical without operative unit	Dental & Oral Care Devices
754	Paediatric dorsiflexion slant board	Other Class A Devices
755	Panniculus skin-adhesive retractor, reusable	Surgical Instruments & Tools
756	Parallel bar exerciser	Physiotherapy & Rehabilitation Devices
757	Parapodium walking frame	Other Class A Devices
758	Partial hand radiation protector	Imaging & Radiology Accessories
759	Patient anatomy model for surgical planning	ENT Devices
760	Patient audiovisual communication system	ENT Devices
762	Patient examination chair/stool/couch	ENT Devices
763	Patient gown, non-sterile	ENT Devices
764	Patient holder	ENT Devices
765	Patient isolation tent canopy	ENT Devices
766	Patient lifting system stretcher	ENT Devices
767	Patient transfer board	ENT Devices
768	Pedal exerciser	Physiotherapy & Rehabilitation Devices
769	Pediatric gait trainer	Other Class A Devices
771	Pelvic floor exerciser, male	Physiotherapy & Rehabilitation Devices
772	Pelvic traction kit (with/without weights)	Orthopaedic & Mobility Devices
773	Percussion hammer, manual/ Manual percussor	Other Class A Devices
774	Periodontal curette, reusable	Surgical Instruments & Tools
775	Periodontal knife/Gingivectomy knife, reusable	Surgical Instruments & Tools
776	Periodontic hoe, reusable	Dental & Oral Care Devices
777	Periotome, reusable	Other Class A Devices
779	Phoropter arm	Other Class A Devices
780	Phototherapy eye protector, reusable	Ophthalmology Devices
781	Phototherapy eye protector, single-use	Ophthalmology Devices
782	Phototherapy infant blanket	Other Class A Devices
783	Physical therapy table, line powered	Patient Support & Hospital Furniture
784	Plaster instruments/plaster saw	Wound Care & Dressings
785	Plaster of Paris bandage	Wound Care & Dressings
786	Plaster spreader	Wound Care & Dressings
787	Plastic surgery osteotome, reusable	Surgical Instruments & Tools
788	Pleoptophor	Other Class A Devices
790	Pneumatic stander	Patient Support & Hospital Furniture
791	Pneumatic walker boot	Orthopaedic & Mobility Devices
792	Polatest	Other Class A Devices
793	Portable system mount	Patient Support & Hospital Furniture
794	Positioning aid system, assistive	Other Class A Devices
795	Postpartum maternity belt	Other Class A Devices
796	Postsurgical head/neck garment	Orthopaedic & Mobility Devices
797	Postsurgical transparent eye shield, vented	Ophthalmology Devices
798	Power wheelchair	Orthopaedic & Mobility Devices
799	Power-assisted foot/hand- propelled tricycle	Other Class A Devices
800	Powered general-purpose operation table	Patient Support & Hospital Furniture
802	Professional examination gown, non-sterile	Other Class A Devices
803	Proprioceptive nest	Other Class A Devices
804	Prosthetic external arm, non- powered	Other Class A Devices
805	Prosthetic external foot (Winged Foot)	Other Class A Devices
806	Prosthetic external foot, pediatric	Other Class A Devices
807	Protective garment for Incontinence	ENT Devices
808	Psychiatric physical restraint	Other Class A Devices
809	Public respirator (2 ply, 3 ply face mask)	Anaesthesia & Respiratory Accessories
810	Pulmonary exerciser	Physiotherapy & Rehabilitation Devices
812	Radiation face protector	Imaging & Radiology Accessories
813	Radiation protection apron	Imaging & Radiology Accessories
814	Radiation protection blanket	Imaging & Radiology Accessories
815	Radiation protection cap	Imaging & Radiology Accessories
816	Radiation protection collar	Imaging & Radiology Accessories
817	Radiation protection gloves	Imaging & Radiology Accessories
818	Radiation protection goggles	Imaging & Radiology Accessories
819	Radiation protection mitten	Imaging & Radiology Accessories
820	Radiographic film illuminator/X-ray LED view panel/ view box	Imaging & Radiology Accessories
821	Radiographic film marking system/ Radiographic film marker, noninvasive, reusable	Imaging & Radiology Accessories
823	Radiographic film, non- screen	Imaging & Radiology Accessories
824	Radiographic grid/X-ray grid/Anti-scatter grid	Imaging & Radiology Accessories
825	Radiographic head holder	Imaging & Radiology Accessories
826	Radiographic intensifying screen	Imaging & Radiology Accessories
827	Radiographic/X-ray cassette holder (wall-mounted/ceiling mounted/floor standing)	Imaging & Radiology Accessories
828	Radiologic patient cradle	ENT Devices
829	Radiologic table	Patient Support & Hospital Furniture
830	Radiological breast positioning device, wearable	ENT Devices
831	Radionuclide test pattern phantom	Other Class A Devices
832	Reciprocating walking frame	Other Class A Devices
833	Reclining wheelchair	Orthopaedic & Mobility Devices
834	Rectal dilator, reusable	Surgical Instruments & Tools
835	Rectal speculum, reusable	Surgical Instruments & Tools
836	Rectoscope/proctoscope handle	Other Class A Devices
838	Rescue blanket/ Emergency Heat loss prevention blanket	Other Class A Devices
839	Retractor holder, reusable	Surgical Instruments & Tools
840	Retractor, abdominal, reusable	Surgical Instruments & Tools
841	Retractor, cardiovascular, reusable	Surgical Instruments & Tools
842	Retractor, ear/nose/throat, reusable	ENT Devices
843	Retractor, laminectomy, reusable	Surgical Instruments & Tools
844	Retractor, orthopaedic, reusable	Surgical Instruments & Tools
845	Retractor, plastic surgery, reusable	Surgical Instruments & Tools
846	Reusable dermatome blade	Other Class A Devices
848	Reverse-image mirror, dental	Dental & Oral Care Devices
849	Rib belt	Other Class A Devices
850	Rib rongeur, reusable	Surgical Instruments & Tools
851	Rigid non-bladed video intubation laryngoscope, reusable	ENT Devices
852	Rollator /Wheeled-walker mobility aid	Orthopaedic & Mobility Devices
853	Rubber dam frame	Other Class A Devices
854	Rubber dam punch	Other Class A Devices
855	Rubber dam, Natural rubber latex	Other Class A Devices
856	Rubber dam, non-latex	Other Class A Devices
858	Scalp clip applier, reusable	Other Class A Devices
859	Scalp clip forceps, reusable	Surgical Instruments & Tools
860	Scalpel blade remover, non- sterile	Surgical Instruments & Tools
861	Scalpel, reusable	Surgical Instruments & Tools
862	Scissors, dental, collar/crown, reusable	Dental & Oral Care Devices
863	Scissors, dental, surgical tissue/ Dental surgical scissors, reusable	Dental & Oral Care Devices
864	Scissors, ear/ Alligator scissors, reusable	ENT Devices
865	Scissors, general-purpose, reusable	Surgical Instruments & Tools
867	Scissors, orthopaedic, reusable	Surgical Instruments & Tools
868	Scissors, plastic surgery, reusable	Surgical Instruments & Tools
869	Scissors, rectal, reusable	Surgical Instruments & Tools
870	Scissors, suture, reusable	Surgical Instruments & Tools
871	Scissors, thoracic, reusable	Surgical Instruments & Tools
872	Scissors, tonsil, reusable	Surgical Instruments & Tools
873	Scissors, umbilical cord, reusable	Surgical Instruments & Tools
874	Scissors, wire cutting, ENT	Surgical Instruments & Tools
875	Sclerotome, reusable	Other Class A Devices
876	Scoop stretcher	Patient Support & Hospital Furniture
877	Screw extractor, reusable	Other Class A Devices
879	Self-retaining ear speculum, reusable	ENT Devices
880	Self-retaining surgical retractor, reusable	Surgical Instruments & Tools
881	Shaped ankle wedge prosthesis, adult	Orthopaedic & Mobility Devices
882	Shaped ankle wedge prosthesis, pediatric	Orthopaedic & Mobility Devices
883	Sharp surgical instrument counting tray/pad	ENT Devices
884	Sharps collection container	Patient Support & Hospital Furniture
885	Shield, resuscitation	Other Class A Devices
886	Shoulder immobilizer	Orthopaedic & Mobility Devices
888	Silicone prosthetic ear	ENT Devices
889	Silicone prosthetic nose	ENT Devices
890	Single-chamber venous compression system garment	Physiotherapy & Rehabilitation Devices
891	Sitz bath chair	Patient Support & Hospital Furniture
892	Sitz bath kit	Other Class A Devices
893	Sitz bath, non-powered	Other Class A Devices
894	Skin abrasion file/ Podiatric bur, reusable	Other Class A Devices
895	Skin adhesive protective material	Other Class A Devices
897	Skin marker guide	Imaging & Radiology Accessories
898	Skin marking transfer paper	Other Class A Devices
899	Skin pressure protectors	Other Class A Devices
900	Skin staple remover, reusable	Other Class A Devices
901	Skin traction kit	Orthopaedic & Mobility Devices
902	Skin-cover sealant/Synthetic polymer liquid barrier cream	Other Class A Devices
903	Skull plate anvil, reusable	Other Class A Devices
904	Slit Lamp	Other Class A Devices
905	Snoring sensor	Other Class A Devices
906	Soft dental reliner	Dental & Oral Care Devices
907	Soft rehabilitation glove	Physiotherapy & Rehabilitation Devices
909	Soft-tissue surgical forceps, scissors-like, reusable	Surgical Instruments & Tools
910	Soft-tissue surgical forceps, tweezers-like, reusable	Surgical Instruments & Tools
911	Solid-ankle-cushion-heel (SACH) foot	Orthopaedic & Mobility Devices
912	Spine orthosis	Orthopaedic & Mobility Devices
913	Spring-loaded dental mallet, reusable	Dental & Oral Care Devices
914	Stair chair	Patient Support & Hospital Furniture
915	Standing wheelchair	Orthopaedic & Mobility Devices
916	Stationary patient lift, electric	ENT Devices
917	Stationary patient lift, manual	ENT Devices
919	Sterilization/disinfection containers	Patient Support & Hospital Furniture
920	Sterilizer/disinfector rack	Patient Support & Hospital Furniture
921	Sternal binder	Patient Support & Hospital Furniture
922	Strabismus ophthalmic hook/ Eye muscle hook, reusable	Ophthalmology Devices
923	Suction system filter, non- sterile	Other Class A Devices
924	Suction/irrigation system canister/bottle holder	Other Class A Devices
925	Surgeon Chair	Patient Support & Hospital Furniture
926	Surgical apparel, non-sterile	Surgical Instruments & Tools
927	Surgical binoculars, reusable	Ophthalmology Devices
929	Surgical bulldog clamp, reusable	Surgical Instruments & Tools
930	Surgical camera and accessories	Surgical Instruments & Tools
931	Surgical camera holder	Surgical Instruments & Tools
932	Surgical cap, non-sterile	Surgical Instruments & Tools
933	Surgical clip rack, reusable	Patient Support & Hospital Furniture
934	Surgical Dilator, reusable	Surgical Instruments & Tools
935	Surgical dissector, reusable	Surgical Instruments & Tools
936	Surgical drill guide, reusable	Surgical Instruments & Tools
937	Surgical eye pressure shield	Ophthalmology Devices
939	Surgical guillotine, reusable	Surgical Instruments & Tools
940	Surgical hair clippers	Surgical Instruments & Tools
941	Surgical hair clippers blade	Surgical Instruments & Tools
942	Surgical hair clippers suction system	Surgical Instruments & Tools
943	Surgical hair clippers suction system tubing set	Patient Support & Hospital Furniture
944	Surgical helmet system, non- sterile	Surgical Instruments & Tools
945	Surgical helmet, non-sterile	Surgical Instruments & Tools
946	Surgical implant handling forceps	Surgical Instruments & Tools
948	Surgical instrument containment holder, single- use, non-sterile	ENT Devices
949	Surgical instrument handle, non-torque-limiting	ENT Devices
950	Surgical instrument holder, reusable	ENT Devices
951	Surgical instrument interim- placement holder, reusable	ENT Devices
952	Surgical instrument rack	ENT Devices
953	Surgical knee cover	Orthopaedic & Mobility Devices
954	Surgical lamp	Surgical Instruments & Tools
955	Surgical lamp (ophthalmic)	Ophthalmology Devices
956	Surgical lens (camera accessory)	Ophthalmology Devices
958	Surgical mallet head, reusable	Surgical Instruments & Tools
959	Surgical mallet/Surgical hammer, reusable	Surgical Instruments & Tools
960	Surgical material compression device, reusable	Physiotherapy & Rehabilitation Devices
961	Surgical microscope and accessories	Surgical Instruments & Tools
962	Surgical probe, reusable	Surgical Instruments & Tools
963	Surgical Punch/Bone Punch, reusable	Surgical Instruments & Tools
964	Surgical Retractor system blade, reusable	Surgical Instruments & Tools
965	Surgical Retractor system, self-retaining	Surgical Instruments & Tools
967	Surgical sleeve cover, non- sterile	Surgical Instruments & Tools
968	Surgical torque wrench adaptor, reusable	Surgical Instruments & Tools
969	Surgical traction tensioner connector	Orthopaedic & Mobility Devices
970	Surgical trays	Surgical Instruments & Tools
971	Surgical video camera	Surgical Instruments & Tools
973	Suture Needle, reusable	Surgical Instruments & Tools
974	Suturing Needle holder, reusable	Surgical Instruments & Tools
975	Suturing Unit, non-powered	Other Class A Devices
976	Swivel-walker	Orthopaedic & Mobility Devices
977	Synoptophor	Other Class A Devices
978	Tachistoscope	Other Class A Devices
979	Tearable adhesive plaster	ENT Devices
980	Tearable adhesive tape	ENT Devices
981	Teething device, fluid-filled	Dental & Oral Care Devices
982	Teething device, non- fluid- filled	Dental & Oral Care Devices
983	Tenotome, reusable	Other Class A Devices
985	Testicular temperature regulation underpants	Other Class A Devices
986	Therapeutic medical binder, general purpose	Patient Support & Hospital Furniture
987	Therapeutic scrotal support	Other Class A Devices
988	Thermoplastic mask for immobilization	Anaesthesia & Respiratory Accessories
989	Thick /Thin Guide Pin, reusable	Other Class A Devices
990	Thumb spica splint	Orthopaedic & Mobility Devices
991	Toe separator	Other Class A Devices
992	Tongue depressor	Other Class A Devices
993	Tongue depressor, surgical	Surgical Instruments & Tools
994	Tongue-retaining sleep- disordered breathing orthosis	Anaesthesia & Respiratory Accessories
995	Tonsil knife, reusable	Surgical Instruments & Tools
996	Torque Wrench, reusable	Other Class A Devices
998	Tracheal surgery dilator, reusable	Surgical Instruments & Tools
999	Tracheostoma protector	Other Class A Devices
1000	Tracheostoma shower shield	Other Class A Devices
1001	Tracheostomy tube holder	Anaesthesia & Respiratory Accessories
1002	Tracheostomy tube lubricant	Incontinence & Hygiene Products
1003	Tracheostomy tube neck holder, single-use	Orthopaedic & Mobility Devices
1004	Tracheotome, reusable	Other Class A Devices
1005	Truncal orthosis	Orthopaedic & Mobility Devices
1006	Tuning fork, ENT	Other Class A Devices
1007	Ulnar/brachial nerve protector	Other Class A Devices
1008	Ultrasonic coupling gel, non- sterile	Other Class A Devices
1009	Ultrasonic safety goggle	Other Class A Devices
1011	Ultrasound imaging phantom, test object	Imaging & Radiology Accessories
1012	Ultrasound imaging system table, non-powered	Imaging & Radiology Accessories
1013	Ultrasound imaging system table, powered	Imaging & Radiology Accessories
1014	Ultrasound imaging transducer positioning unit	Imaging & Radiology Accessories
1015	Umbilical cord clamp, reusable	Surgical Instruments & Tools
1016	Umbilical ligator, reusable	Other Class A Devices
1017	Urinary dilator, reusable	Surgical Instruments & Tools
1018	Urinary-incontinence vaginal insert, reusable	Incontinence & Hygiene Products
1019	Urological operating table top	Incontinence & Hygiene Products
1020	Urological operating table, electrohydraulic	Incontinence & Hygiene Products
1022	Urological operating table, hydraulic/Transurethral resection table	Incontinence & Hygiene Products
1023	Uterine packer, reusable	Other Class A Devices
1024	Vacuum cushion (Patient- positioning device)	Other Class A Devices
1025	Vacuum splint	Orthopaedic & Mobility Devices
1026	Vaginal applicator, non- sterile, single use	Surgical Instruments & Tools
1027	Vaginal applicator, reusable	Surgical Instruments & Tools
1028	Vaginal exerciser/Pelvic floor muscle exerciser, female	Physiotherapy & Rehabilitation Devices
1029	Vaginal illuminator	Other Class A Devices
1030	Vaginal speculum, reusable	Surgical Instruments & Tools
1031	Valsalva manoeuvre mouthpiece	Dental & Oral Care Devices
1033	Vascular compression system, reusable	Physiotherapy & Rehabilitation Devices
1034	Vascular scissors/ micro- scissors, reusable	Surgical Instruments & Tools
1035	Vein stripper, reusable	Other Class A Devices
1036	Vice grip, reusable	Other Class A Devices
1037	Video indirect ophthalmoscope	Ophthalmology Devices
1038	Video intubation laryngoscope handle/monitor	ENT Devices
1039	Video laryngoscope adaptor	ENT Devices
1041	Vision training software	Ophthalmology Devices
1042	Visitor hygiene coverall	Other Class A Devices
1043	Visual chart	Other Class A Devices
1044	Visual light box	Other Class A Devices
1045	Visual projector	Other Class A Devices
1046	Visual field plotter	Ophthalmology Devices
1047	Vitrectomy lenses	Ophthalmology Devices
1048	Waiting area chair	Patient Support & Hospital Furniture
1049	Wash basin stand	Patient Support & Hospital Furniture
1050	Washers for body waste receptacles	Other Class A Devices
1051	Weight activated knee joint external prosthesis	Orthopaedic & Mobility Devices
1052	Weight-bearing protector for flat panel x-ray detector/film cassette	ENT Devices
1053	Wheelchair	Orthopaedic & Mobility Devices
1055	Wire tensioner, reusable	Physiotherapy & Rehabilitation Devices
1056	Woven gauze pad, non- sterile	Wound Care & Dressings
1057	Woven gauze roll, non-sterile	Wound Care & Dressings
1058	Woven gauze sheet, non- sterile	Wound Care & Dressings
1059	Wrist immobilizer	Orthopaedic & Mobility Devices
1060	Wrist splint	Orthopaedic & Mobility Devices
1061	Wrist/hand/finger flexion orthosis, manual	Orthopaedic & Mobility Devices
1062	Wrist/hand/finger stable- position orthosis	Orthopaedic & Mobility Devices
1063	Wrist/hand/metacarpophalan geal joint extension orthosis	Orthopaedic & Mobility Devices
1064	X- ray marker for strut	Imaging & Radiology Accessories
1065	X-ray film cover	Imaging & Radiology Accessories
1067	X-ray film processing chemical, automatic	Imaging & Radiology Accessories
1068	X-ray film processing chemical, manual	Imaging & Radiology Accessories
1069	X-Ray hanger	Imaging & Radiology Accessories

Documents Required for CDSCO Class A Medical Device Registration

The documentation requirement for Class A device registration is relatively simple compared to higher classes. Here is the complete checklist:

For Indian Manufacturers

Document	Description / Requirement
Registration Application Form (Form MD-1)	Duly filled online application on the Sugam portal (sugamya.cdsco.gov.in)
Proof of Establishment / Business Registration	Certificate of Incorporation, GST registration, or trade license of the manufacturing entity
Device Description & Intended Use	Technical description matching the CDSCO Class A list; intended use statement
Manufacturing Address Proof	Factory/production facility address with proof (utility bill, lease deed, etc.)
Declaration of Conformity	Self-declaration confirming the device is non-sterile, non-measuring, and falls under Class A
Quality Management System Certificate	ISO 13485 certificate (preferred) or equivalent QMS documentation
List of Similar Devices (if applicable)	Reference to similar devices already registered, if available
Power of Attorney (if agent is applying)	Authorized signatory details and power of attorney letter

Additional Documents for Importers / Foreign Manufacturers

Document	Description / Requirement
CE Mark / USFDA / TGA Certificate	Valid certification from a recognized regulatory authority in the country of origin
Free Sale Certificate (FSC)	Certificate confirming the device is legally sold in the country of manufacture
Indian Authorized Agent (IAA) Agreement	Signed agreement between foreign manufacturer and Indian representative
IAA Registration Certificate	CDSCO registration of the Indian Authorized Agent
Product Labeling (English)	Label compliant with MDR 2017 requirements (product name, manufacturer, batch, expiry if applicable)
Device-specific technical documentation	Functional description, design drawings, material composition (basic level for Class A)

Step-by-Step Process: How to Register Class A Medical Devices

The registration process for Class A medical devices in India has been fully digitized through the CDSCO Sugam portal. Here is the complete step-by-step walkthrough for 2026:

Step 1: Create Account on CDSCO Sugam Portal

Visit the official CDSCO Sugam portal.
Register as a 'Manufacturer' or 'Importer' based on your entity type
Verify your email and mobile number for OTP-based authentication
Set up your company profile with GSTIN, PAN, and authorized signatory details

Step 2: Confirm Your Device Class A

Cross-check your product name against the official CDSCO Class A list (Appendix A, F. No. MED-16014(12)/1/2024)
Verify the intended use of your product matches the description in the list exactly
If your device is not on the list, consult a regulatory expert — it may fall under a different class

Step 3: Prepare and Upload Documents

Gather all documents as per the checklist above (Indian manufacturers / importers)
Ensure all documents are in PDF format, clearly legible, and below the portal's file size limits
Self-declarations must be signed by the authorized signatory on company letterhead
Foreign manufacturers must ensure their IAA documents are in order before this step

Step 4: Fill and Submit Form MD-1 Online

Log into the Sugam portal and select 'Registration of Class A Medical Devices'
Fill Form MD-1 carefully — device name must exactly match the Class A list
Upload all required documents in designated fields
Pay the prescribed registration fee online via payment gateway
Submit the application and save the application reference number

Step 5: CDSCO Review and Processing

CDSCO officers review the submitted documents for completeness and accuracy
If any discrepancy or missing document is found, a query letter will be raised on the portal
Respond to queries promptly with correct documents through the portal (not by email)
Timeline: Most Class A registrations are processed within 30–45 working days if documents are complete

Step 6: Receive Registration Certificate

Upon approval, the Registration Certificate is issued digitally and downloadable from the Sugam portal
The certificate contains registration number, valid from/to dates, device details, and registrant's information
This certificate must be available for audit, shown to distributors, and referenced on device labels

2026 Update: CDSCO has strengthened online monitoring of Class A registrations. Random audits are now conducted to verify compliance. Ensure your registration is always current and device labels match the registered information.

CDSCO Registration Fees for Class A Medical Devices

The registration fee for Class A medical devices is prescribed under the Second Schedule of MDR 2017 and is significantly lower than licensing fees for higher-class devices:

Fee Type	Amount (INR)
Registration fee — Indian Small Manufacturer (Turnover < ₹10 crore)	₹1,000 per device
Registration fee — Indian Medium/Large Manufacturer	₹5,000 per device
Registration fee — Importer (per device)	₹5,000 per device
Amendment / Modification to existing registration	₹1,000 – ₹2,500 (depending on change type)
Renewal of Registration Certificate	Same as initial registration fee
Late Renewal Penalty (post-expiry)	Additional fee as per MDR 2017 schedule

Pro Tip: Fees are subject to revision. Always verify the current fee schedule on the official CDSCO Sugam portal or CDSCO's official website (cdsco.gov.in) before submitting your application.

Validity and Renewal of CDSCO Class A Device Registration

Understanding the validity and renewal process is critical to maintaining compliance. Here is what you need to know:

Aspect	Details
Validity Period	Typically 5 years from the date of issue of the Registration Certificate
Renewal Application Timeline	Must be filed at least 30 days before the expiry of the current certificate
Renewal Process	Same as initial registration — submit via Sugam portal with updated documents if any changes occurred
Consequences of Expired Registration	Selling devices with an expired certificate is non-compliant with MDR 2017 and liable to penalties
Device Discontinuation	If a device is discontinued, inform CDSCO by filing a withdrawal application to avoid compliance issues
Changes in Device / Company Info	Any change (address, device description, manufacturer name) requires an amendment application before selling

Key Benefits of CDSCO Registration for Class A Medical Devices

Completing your Class A device registration is not just a legal obligation — it actually provides tangible business advantages:

1. Legal Market Access

A valid CDSCO registration certificate is your ticket to legally sell, distribute, and import Class A medical devices in India. Hospitals, pharmacies, and distributors increasingly insist on seeing registration certificates before onboarding new suppliers.

2. Simplified Regulatory Pathway

Unlike Class B, C, or D devices, Class A registration does not require clinical data, performance testing submissions, or inspection of manufacturing facilities. This makes it one of the fastest and most cost-effective regulatory pathways globally.

3. Build Buyer and Institutional Trust

Registered devices carry the CDSCO registration number — a trust signal for hospitals, procurement committees, government tenders, and institutional buyers. In competitive government tenders (GEM portal, state procurement), registration is often a mandatory criterion.

4. Reduced Compliance Burden

Class A devices are exempt from post-market surveillance reporting requirements that apply to higher-class devices. The ongoing compliance burden is minimal — primarily involving registration renewal and label compliance.

5. Export Readiness

India's CDSCO registration is recognized by many importing countries as evidence of regulatory compliance. Having your Class A device registered also simplifies getting Free Sale Certificates (FSC) from CDSCO for export purposes.

6. Protection Against Enforcement Actions

CDSCO and state drug inspectors regularly conduct market checks. Unregistered devices can be seized, businesses can face show-cause notices, and legal proceedings can result in significant financial and reputational damage. Registration is your shield.

Common Mistakes to Avoid in Class A Device Registration

Based on common applicant errors observed in practice, here are the key mistakes to avoid:
Selecting the wrong device category — always cross-verify intended use with the exact description in the Class A list
Using a device name that doesn't exactly match the official CDSCO list — even minor variations can cause rejection
Submitting incomplete or illegible documents — ensure all PDFs are clear and all fields are filled
Not appointing a valid Indian Authorized Agent (IAA) before applying as a foreign manufacturer
Ignoring query letters from CDSCO — unanswered queries lead to automatic rejection of the application
Forgetting to renew the registration certificate before expiry — continue selling without a valid certificate leads to legal risk
Not updating CDSCO when manufacturing address or company name changes — selling devices with mismatched registration info is non-compliant
Assuming the registration covers all variants — each distinct device configuration may require a separate entry

Conclusion: Navigate CDSCO Class A Registration with Confidence

CDSCO registration for Class A medical devices may be the simplest regulatory pathway in India's medical device framework — but simple does not mean optional. As India's medical device market continues its rapid growth, CDSCO is actively strengthening enforcement, and unregistered devices face increasing scrutiny from buyers, hospitals, government procurement agencies, and inspectors.

The good news is that if your device genuinely qualifies as Class A non-sterile and non-measuring, the registration process is straightforward, affordable, and fully digital. With the right documents, accurate device classification, and timely filing through the Sugam portal, most registrations are completed within 30–45 working days.

Use this guide as your go-to reference. The complete list of 968+ Class A devices provided here is based directly on the official CDSCO notification — not assumptions or third-party interpretations. Bookmark this page, cross-check your device, and begin your registration with confidence.

Frequently Asked Questions

Is CDSCO registration mandatory for Class A medical devices in India?

Yes, absolutely. While Class A non-sterile, non-measuring devices are exempt from licensing under MDR 2017, registration under Chapter IIIB is mandatory before any device can be sold, distributed, or imported in India. Skipping registration is a legal violation.

What is the difference between CDSCO registration and a license for medical devices?

Registration (applicable to Class A non-sterile, non-measuring devices) is a simpler process involving basic documentation and self-declaration. Licensing (required for Class A sterile/measuring, B, C, and D devices) involves a more rigorous process including facility inspection, clinical data, and formal government approval. Registration does not equal licensing.

How long does CDSCO Class A device registration take?

If all documents are complete and accurate, CDSCO typically processes Class A registrations within 30 to 45 working days. Incomplete applications or unanswered query letters can extend this timeline significantly.

Can I sell a Class A medical device in India before receiving the registration certificate?

No. You must obtain the Registration Certificate from CDSCO before placing the device in the Indian market. Selling an unregistered device — even if it qualifies as Class A — is a violation of MDR 2017 and can attract penalties, seizure, or prosecution.

Do I need ISO 13485 certification to register a Class A device?

ISO 13485 (Quality Management System for Medical Devices) is not strictly mandatory for Class A device registration. However, it is strongly recommended and is often requested during queries or audits. Having ISO 13485 can speed up the registration process and demonstrates quality compliance to buyers and hospitals.

What if my device is not on the official Class A list?

If your medical device is not listed in the official CDSCO Class A list (Appendix A), you should not assume it is unregulated. It may fall under Class B, C, or D, or it may require classification guidance from CDSCO. You can raise a classification query with CDSCO's medical device division before filing any application.

Can a foreign manufacturer register a Class A device directly with CDSCO?

No. Foreign manufacturers must appoint a valid Indian Authorized Agent (IAA) who is registered with CDSCO. The IAA applies on behalf of the foreign manufacturer and is the legally responsible party in India. All communications from CDSCO will go to the IAA.

Is there any post-registration compliance requirement for Class A devices?

Class A devices are exempt from many post-market surveillance requirements. However, manufacturers and importers must maintain device records, ensure labels remain compliant, renew registration before expiry, and promptly inform CDSCO of any significant changes to the device or the company.

Can one registration cover multiple variants of the same device?

Each distinct device (with a different intended use or product name as per the Class A list) generally requires a separate registration entry. However, minor variants of the same device (e.g., different sizes of the same surgical scissors) may sometimes be covered under one registration entry, depending on how the Class A list defines that device.

What happens if my Class A device registration expires and I don't renew?

If your registration certificate expires and you continue to sell or distribute the device, you are technically operating with an unregistered device — which is a violation of MDR 2017. You may face market seizures, show-cause notices, or legal proceedings.

Jyoti Sharma

Jyoti Sharma is a Digital Marketing Executive at Silvereye Certifications with expertise in SEO, WordPress, AI tools, and certification & compliance industry marketing solutions.

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