CDSCO Registration for Class C Medical Devices – Complete Guide For Medical Device Licensing — Device List, Process, Documents, & Fees

Q: Can I import and sell a Class B device in India without a license?

Absolutely not. Importing or selling a Class B device in India without a valid CDSCO import license is a direct violation of MDR 2017. Unregistered devices can be seized at customs, fines can be imposed, and persistent violations can lead to criminal prosecution. The Indian Authorized Agent (IAA) is the legal face of the foreign manufacturer in India.

Q: When should I renew my Class B license, and what happens if I miss the deadline?

Apply for renewal at least 30 days before expiry — and ideally 3–6 months in advance for manufacturing licenses (which may require re-inspection). If your license expires before renewal is granted, you are technically not authorized to continue manufacturing or selling during the gap period. CDSCO may grant a grace period in certain cases, but this cannot be relied upon. Never let your license lapse.

497 devices classified as Class C — moderate-risk, requiring a full CDSCO manufacturing or import license.
Class B licensing governed by Chapter IV of MDR 2017 — mandatory before manufacture, import, or sale.
Covers 20 medical speciality categories — from dental and gastroenterology to paediatrics, respiratory, and software.
2026 update: CDSCO Sugam portal fully digitized — apply online, track status, and renew your Class B license seamlessly.

What is CDSCO Class C Medical Device Registration?

If you manufacture, import, or plan to sell CDSCO Registration For Class C medical devices in India, you already know the stakes. Class C sits in the third tier of India's four-tier medical device risk classification — above the low-risk Class A and below the high-risk Class C and D. This mid-tier position means Class B devices carry moderate-to-high risk and subject to mandatory licensing under the Medical Devices Rules (MDR), 2017.

The Central Drugs Standard Control Organization (CDSCO), India's apex medical device regulator under the Ministry of Health and Family Welfare, oversees Class B device licensing. Unlike Class A (non-sterile, non-measuring) devices which only require registration, Class B devices require a full manufacturing license or import license — and selling without one is a punishable violation of MDR 2017.

Official Source: The 497 Class C devices listed in this guide are sourced from Annexure II of CDSCO's official Medical Device Classification document. Each device name and category is directly from the official CDSCO classification — not from third-party interpretations. This guide is maintained for accuracy and freshness as of 2026.

India's Medical Device Risk Classification — Where Does Class B Fit?

Understanding the four-class structure under MDR 2017 helps you see exactly what regulatory obligations come with Class B:

Device Class	Risk Level & Key Regulatory Requirement
Class A (Non-Sterile, Non-Measuring)	Lowest risk. Registration only (Chapter IIIB). No manufacturing license required.
Class A (Sterile or Measuring)	Low risk with sterility/measuring function. Full license under Chapter IV required.
Class B ← You are here	Moderate-to-high risk. Manufacturing license + import license required under Chapter IV. Clinical performance evidence may be required for some devices.
Class C	Moderate-to-high risk. Stricter licensing, clinical investigation data, notified body involvement.
Class D	Highest risk (life-sustaining, implantable). Most rigorous regulatory pathway, clinical evidence mandatory.

Key takeaway: Class B devices are not as lightly regulated as Class A, but not as demanding as Class C or D. You need a valid CDSCO license, proper technical documentation, and quality system compliance — but you generally don't need full clinical trial data like Class D.

Who Needs a CDSCO Class C Medical Device License?

Under MDR 2017, a CDSCO Class C device license is mandatory for:

Indian manufacturers producing Class C medical devices for sale anywhere in India
Importers bringing Class B devices from foreign countries into the Indian market
Foreign manufacturers selling Class B devices in India through an Indian Authorized Agent (IAA)
Contract manufacturers producing Class B devices on behalf of brand owners
Relabellers or repackagers of imported Class B devices
Loan licensees using another manufacturer's licensed facility to produce Class B devices

Important: There is NO grace period for unregistered Class B devices. If you are currently selling, distributing, or importing a Class B device without a valid CDSCO license, you are in violation of MDR 2017 and are exposed to product seizure, financial penalties, and potential prosecution. Act promptly.

Eligibility Criteria for CDSCO Class C Device License

Before applying, ensure your device and business meet these eligibility conditions:

Eligibility Criterion	What It Means for You
Device Must Be Class B	Confirm your device appears in the official CDSCO Class C list. Using the wrong class results in application rejection.
Legal Entity Registration	Applicant must be a legally registered business in India — private limited company, LLP, proprietorship, or partnership firm.
Manufacturing Site Compliance	Manufacturing premises must comply with Schedule M (Good Manufacturing Practices for Medical Devices) under MDR 2017.
ISO 13485 Certification	Strongly recommended; required for some device types. Quality Management System certification demonstrates manufacturing capability.
For Importers: Valid IAA	Foreign manufacturers must appoint a registered Indian Authorized Agent (IAA) who will hold the import license.
For Importers: Home Country Approval	Device must be legally marketed in the country of manufacture — Free Sale Certificate (FSC) or equivalent required.
Competent Technical Staff	Manufacturer must have technically qualified personnel as per MDR 2017 requirements (e.g., Diploma/Degree in relevant field).
Device Not Higher Classified	Device must genuinely be Class B — not a device that should be classified as C or D.

Complete List of CDSCO Class C Medical Devices — All 751 Devices

The table below is the complete, official CDSCO Class C medical device list sourced directly from Annexure II of CDSCO's classification document. This covers all 497 Class C devices across 20 medical speciality categories. Use this list to confirm your device's classification before applying for a license.

How to Use This Table: Scroll through the table to find your device by name. The 'Medical Category' column helps you identify the speciality. If your device appears here as Class B, you need a full CDSCO manufacturing or import license under MDR 2017. If your device is NOT in this list, it may be Class A, C, or D — consult a regulatory expert before applying.

S.No.	Medical Device Name	Medical Category	CDSCO Class
1	Anesthesia machine	Anesthesiology	Class C
2	Airway pressure/oxygen monitor	Anesthesiology	Class C
3	anaesthesia vaporizer	Anesthesiology	Class C
4	Carbon dioxide monitor	Anesthesiology	Class C
5	High-frequency ventilator	Anesthesiology	Class C
6	Intravascular membrane oxygenator	Anesthesiology	Class C
7	Manual jet ventilation device	Anesthesiology	Class C
8	Negative-pressure ventilator	Anesthesiology	Class C
9	Oxygen/air/nitrous oxide breathing gas mixer	Anesthesiology	Class C
10	Patient physiologic monitoring system	Anesthesiology	Class C
11	Pulmonary resuscitator	Anesthesiology	Class C
12	Pulse oximeter	Anesthesiology	Class C
13	Tracheostomy kit	Anesthesiology	Class C
14	Analgesic peripheral nerve electrical stimulation system	Pain Management	Class C
15	Analgesic spinal cord electrical stimulation system	Pain Management	Class C
16	Cryogenic analgesia unit	Pain Management	Class C
17	Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system	Pain Management	Class C
18	Epidural anaesthesia kit	Pain Management	Class C
19	Epidural/intrathecal anaesthesia kit	Pain Management	Class C
20	Flexible fibreoptic epiduroscope	Pain Management	Class C
21	Medium-wave diathermy treatment system	Pain Management	Class C
22	Microwave diathermy treatment system	Pain Management	Class C
23	Multi-modality physical therapy system	Pain Management	Class C
24	Musculoskeletal intense therapeutic ultrasound system	Pain Management	Class C
25	Musculoskeletal/physical therapy laser	Pain Management	Class C
26	Neurophysiologic monitoring system	Pain Management	Class C
27	Transcutaneous Electro- Neuro Stimulator (TENS) devices	Pain Management	Class C
28	Arrhythmia Detector And Alarm (Including St- Segment Measurement And Alarm).	Cardiovascular	Class C
29	Electrocardiograph electrode.	Cardiovascular	Class C
30	Intra-aortic balloon and control system.	Cardiovascular	Class C
31	Pacing system analyzer.	Cardiovascular	Class C
32	Pacemaker lead adaptor.	Cardiovascular	Class C
33	Annuloplasty ring.	Cardiovascular	Class C
34	Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure	Cardiovascular	Class C
35	Cardiopulmonary bypass defoamer.	Cardiovascular	Class C
36	Cardiopulmonary bypass arterial line blood filter.	Cardiovascular	Class C
37	External cardiac compressor.	Cardiovascular	Class C
38	External transcutaneous cardiac pacemaker	Cardiovascular	Class C
39	Dental bone matrix implant, animal- derived	Dental	Class C
40	Carboxymethylcellul ose sodium denture adhesive	Dental	Class C
41	Carboxymethylcellul ose sodium/polymer denture adhesive, zinc-free	Dental	Class C
42	Dental amalgam	Dental	Class C
43	Dental amalgam alloy	Dental	Class C
44	Dental amalgam mercury	Dental	Class C
45	Temporary mandibular condyle prosthesis	Dental	Class C
46	Temporomandibular joint disc	Dental	Class C
47	Transgingival implant	Dental	Class C
48	Transmandibular implant	Dental	Class C
49	Pliable-polymer dental regeneration membrane, bioabsorbable, ligated	Dental	Class C
50	Pliable-polymer dental regeneration membrane, bioabsorbable, tacked	Dental	Class C
51	Dental surgical procedure kit, medicated, reusable	Dental	Class C
52	Dental surgical procedure kit, medicated, single- use	Dental	Class C
53	Membrane fixation tack, bioabsorbable	Dental	Class C
54	Periodontal root surface regeneration material	Dental	Class C
55	Periodontal tissue reconstructive material	Dental	Class C
56	Bone matrix implant, human- derived	Dental	Class C
57	Collagen dental regeneration membrane	Dental	Class C
58	Dental anaesthesia system	Dental	Class C
59	Calcium hydroxide dental cement	Dental	Class C
60	Dental soft-tissue matrix implant, animal-derived	Dental	Class C
61	Anchored bone-conduction hearing implant system	ENT (Ear, Nose & Throat)	Class C
62	Auditory stimulator	ENT (Ear, Nose & Throat)	Class C
63	Behind-the-ear bone- conduction tinnitus masker	ENT (Ear, Nose & Throat)	Class C
64	Cochlear implant assessment system	ENT (Ear, Nose & Throat)	Class C
65	Ear prosthesis	ENT (Ear, Nose & Throat)	Class C
66	Ossicular prosthesis, partial	ENT (Ear, Nose & Throat)	Class C
67	Middle ear mold	ENT (Ear, Nose & Throat)	Class C
68	Fully-implantable middle ear implant system	ENT (Ear, Nose & Throat)	Class C
69	Larynx prosthesis	ENT (Ear, Nose & Throat)	Class C
70	Ossicular prosthesis, total	ENT (Ear, Nose & Throat)	Class C
71	Ear, nose, and throat electric or pneumatic surgical drill	ENT (Ear, Nose & Throat)	Class C
72	Argon laser for otology, rhinology, and laryngology	ENT (Ear, Nose & Throat)	Class C
73	Ear, nose, and throat microsurgical carbon dioxide laser	ENT (Ear, Nose & Throat)	Class C
74	Suction antichoke device	ENT (Ear, Nose & Throat)	Class C
75	Tongs antichoke device	ENT (Ear, Nose & Throat)	Class C
76	External upper esophageal sphincter compression device	ENT (Ear, Nose & Throat)	Class C
77	Active implantable bone conduction hearing system	ENT (Ear, Nose & Throat)	Class C
78	Partial ossicular replacement prosthesis	ENT (Ear, Nose & Throat)	Class C
79	Total ossicular replacement prosthesis	ENT (Ear, Nose & Throat)	Class C
80	Mandibular implant facial prosthesis	ENT (Ear, Nose & Throat)	Class C
81	Sacculotomy tack (Cody tack)	ENT (Ear, Nose & Throat)	Class C
82	Tympanostomy tube with semipermeable membrane	ENT (Ear, Nose & Throat)	Class C
83	Transcutaneous air conduction hearing aid system	ENT (Ear, Nose & Throat)	Class C
84	Gustometer	ENT (Ear, Nose & Throat)	Class C
85	Anal fistula seton	Gastroenterology	Class C
86	Bile duct prosthesis	Gastroenterology	Class C
87	Biliary drainage catheter	Gastroenterology	Class C
88	Colonic mucosa barrier dressing	Gastroenterology	Class C
89	Duodenal bypass liner	Gastroenterology	Class C
90	Duodenal-jejunal bypass liner	Gastroenterology	Class C
91	Enteral feeding kit, adult/paediatric, non-sterile	Gastroenterology	Class C
92	Enteral feeding kit, adult/paediatric, sterile	Gastroenterology	Class C
93	Enteral feeding tube clearing kit	Gastroenterology	Class C
94	Gastric sleeve	Gastroenterology	Class C
95	Gastrointestinal anastomosis coupler, non-bioabsorbable	Gastroenterology	Class C
96	Gastrointestinal endoscopic clip, long- term	Gastroenterology	Class C
97	Gastrointestinal endoscopic clip, short-term	Gastroenterology	Class C
98	Gastrojejunostomy tube	Gastroenterology	Class C
99	Gastro-oesophageal antireflux prosthesis	Gastroenterology	Class C
100	Gastrostomy aspiration system gravity set	Gastroenterology	Class C
101	Gastrostomy aspiration system stomach tube	Gastroenterology	Class C
102	Gastrostomy button	Gastroenterology	Class C
103	Gastrostomy T fastener	Gastroenterology	Class C
104	Gastrostomy tube	Gastroenterology	Class C
105	Implantable gastric clamp	Gastroenterology	Class C
106	Implantable incontinence-control electrical stimulation system	Gastroenterology	Class C
107	Implantable peritoneal catheter holder	Gastroenterology	Class C
108	Intestinal splint	Gastroenterology	Class C
109	Jejunostomy tube	Gastroenterology	Class C
110	Nasoenteral tube	Gastroenterology	Class C
111	Non-vascular catheter introduction set	Gastroenterology	Class C
112	Oesophageal tube	Gastroenterology	Class C
113	Paediatric-temperature nasogastric/orogastric tube	Gastroenterology	Class C
114	Partially-implantable abdominal port/catheter	Gastroenterology	Class C
115	Pharyngeal electrical stimulation catheter	Gastroenterology	Class C
116	Probiotic oropharyngeal mucosa dressing	Gastroenterology	Class C
117	Robotic electrosurgical instrument, bipolar, single-use	Gastroenterology	Class C
118	Stoma support implant	Gastroenterology	Class C
119	Thermal-regulation orogastric tube	Gastroenterology	Class C
120	Transenteric drainage tube	Gastroenterology	Class C
121	Bare-metal urethral stent, short-term	Urology	Class C
122	Electromechanical lithotripsy system, extracorporeal	Urology	Class C
123	Hydraulic male urinary incontinence treatment system	Urology	Class C
124	Hydraulic male urinary incontinence treatment system port	Urology	Class C
125	Hydraulic male urinary incontinence treatment system tubing	Urology	Class C
126	Hydraulic male urinary incontinence treatment system tubing plug	Urology	Class C
127	Inflatable penile prosthesis	Urology	Class C
128	Laser lithotripsy fibre/suction guide	Urology	Class C
129	Laser lithotripsy system	Urology	Class C
130	Microwave hyperthermia system catheter, prostatic-ablation, reusable	Urology	Class C
131	Perineal orifice incontinence-control electrical stimulation system, remote control	Urology	Class C
132	Piezoelectric lithotripsy system	Urology	Class C
133	Electronic monitor for gravity flow infusion systems	General Hospital	Class C
134	Infant radiant warmer.	General Hospital	Class C
135	Neonatal incubator.	General Hospital	Class C
136	Neonatal transport incubator.	General Hospital	Class C
137	Jet lavage.	General Hospital	Class C
138	Infusion pump.	General Hospital	Class C
139	Chemical cold pack snakebite kit.	General Hospital	Class C
140	Ingestible event marker.	General Hospital	Class C
141	Ultraviolet (UV) radiation chamber disinfection device.	General Hospital	Class C
142	Ethylene oxide gas sterilizer.	General Hospital	Class C
143	Dry-heat sterilizer.	General Hospital	Class C
144	Steam sterilizer.	General Hospital	Class C
145	Liquid chemical sterilants/high level disinfectants.	General Hospital	Class C
146	Wheeled stretcher.	General Hospital	Class C
147	Medical washer-disinfector.	General Hospital	Class C
148	Hydrogen Peroxide Gas Plasma Sterilization System	General Hospital	Class C
149	Environmental chamber for storage of platelet concentrate	General Hospital	Class C
150	Blood storage refrigerator	General Hospital	Class C
151	Automated blood cell separator	General Hospital	Class C
152	General-purpose electrosurgical unit	Operation Theatre (OT)	Class C
153	Long-term use enterostomy feeding tube	Operation Theatre (OT)	Class C
154	Gastrostomy tube for long-term use	Operation Theatre (OT)	Class C
155	Warming high-flow infusion pump	Operation Theatre (OT)	Class C
156	High-flow blood transfusion pump	Operation Theatre (OT)	Class C
157	Multiparameter monitor with critical parameters	Operation Theatre (OT)	Class C
158	Surgical robot unit	Operation Theatre (OT)	Class C
159	Artificial airway washing/disinfection jar	Respiratory	Class C
160	Breathing circuit washer/disinfector	Respiratory	Class C
161	Hyperbaric chamber	Respiratory	Class C
162	Negative-pressure ventilator	Respiratory	Class C
163	Pulse oximeter	Respiratory	Class C
164	Therapeutic positive pressure breathing ventilator	Respiratory	Class C
165	Thoracic electrical impedance tomography system	Respiratory	Class C
166	Autonomic neuropathy heart rate meter	Neurological	Class C
167	Behavioural therapy electrical stimulation system	Neurological	Class C
168	Brain injury adjunctive interpretive electroencephalograph assessment aid.	Neurological	Class C
169	Cerebrospinal fluid manometer,	Neurological	Class C
170	Cerebrospinal fluid shunt valve programmer	Neurological	Class C
171	Computerized cognitive assessment aid.	Neurological	Class C
172	Craniotomy power tool system handpiece	Neurological	Class C
173	Cutaneous electrode.	Neurological	Class C
174	Deep brain electrical stimulation system lead	Neurological	Class C
175	Depth electrode.	Neurological	Class C
176	Diagnostic peripheral nerve electrical stimulation system	Neurological	Class C
177	Dura mater sealant	Neurological	Class C
178	Echoencephalograph.	Neurological	Class C
179	Ejaculation electrical stimulation system	Neurological	Class C
180	Electroconvulsive therapy system	Neurological	Class C
181	Electroencephalograph.	Neurological	Class C
182	Electroencephalographic monitoring system	Neurological	Class C
183	Epicranial brain electrical stimulation system	Neurological	Class C
184	Home seizure monitoring system	Neurological	Class C
185	Implantable lumbar neuromuscular electrical stimulation system programmer	Neurological	Class C
186	Implantable sleep apnoea treatment system programmer/charger	Neurological	Class C
187	Implantable spinal cord electrical stimulation system programmer	Neurological	Class C
188	Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer	Neurological	Class C
189	Intranasal cooling system	Neurological	Class C
190	Intranasal lacrimal neurostimulator	Neurological	Class C
191	Invasive-detection physiological monitor	Neurological	Class C
192	Nasopharyngeal electrode.	Neurological	Class C
193	Needle electrode.	Neurological	Class C
194	Nerve conduction velocity measurement device.	Neurological	Class C
195	Neurological endoscope.	Neurological	Class C
196	Neurological stereotactic surgery system	Neurological	Class C
197	Neuromuscular transmission electrical skin sensor	Neurological	Class C
198	Neuropsychiatric interpretive electroencephalograph assessment aid.	Neurological	Class C
199	Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.	Neurological	Class C
200	Olfactometry system	Neurological	Class C
201	Photodiode subretinal prosthesis system	Neurological	Class C
202	Scalp clip.	Neurological	Class C
203	Spinal needle bioimpedance navigation unit	Neurological	Class C
204	Stereotactic neuronavigation/planning system	Neurological	Class C
205	Vagus nerve electrical stimulation system programmer	Neurological	Class C
206	Abdominal decompression chamber	Obstetrical and Gynaecological (OG)	Class C
207	Abdominal decompression chamber pump	Obstetrical and Gynaecological (OG)	Class C
208	Cardiotocograph	Obstetrical and Gynaecological (OG)	Class C
209	Cardiotocograph transducer	Obstetrical and Gynaecological (OG)	Class C
210	Cardiotocography telemetric monitoring system	Obstetrical and Gynaecological (OG)	Class C
211	Cardiotocography telemetric monitoring system receiver	Obstetrical and Gynaecological (OG)	Class C
212	Cardiotocography telemetric monitoring system transmitter	Obstetrical and Gynaecological (OG)	Class C
213	Contraceptive cervical cap, reusable or single use	Obstetrical and Gynaecological (OG)	Class C
214	Contraceptive spermicide	Obstetrical and Gynaecological (OG)	Class C
215	Contraceptive sponge	Obstetrical and Gynaecological (OG)	Class C
216	Diaphragm pessary	Obstetrical and Gynaecological (OG)	Class C
217	Foetal bladder shunt	Obstetrical and Gynaecological (OG)	Class C
218	Foetal cardiac monitor	Obstetrical and Gynaecological (OG)	Class C
219	Foetal pleuro-amniotic catheter	Obstetrical and Gynaecological (OG)	Class C
220	Foetal scalp electrode, clip	Obstetrical and Gynaecological (OG)	Class C
221	Breast transilluminator	Obstetrical and Gynaecological (OG)	Class C
222	Capsular bag anchor	Ophthalmic	Class C
223	Contact lens agitation cleaning system	Ophthalmic	Class C
224	Contact lens disinfecting solution	Ophthalmic	Class C
225	Contact lens protein-removal solution	Ophthalmic	Class C
226	Contact lens thermal cleaner	Ophthalmic	Class C
227	Corneal inlay, aperture reducing	Ophthalmic	Class C
228	Corneal inlay, cornea- reshaping	Ophthalmic	Class C
229	Donor cornea container	Ophthalmic	Class C
230	Endoscopic-imaging ophthalmic solid-state laser system	Ophthalmic	Class C
231	Eye muscle sleeve	Ophthalmic	Class C
232	Eye valve	Ophthalmic	Class C
233	Eyelid weight, implantable	Ophthalmic	Class C
234	Femtosecond ophthalmic solid- state laser system	Ophthalmic	Class C
235	Fundus-imaging ophthalmic diode laser system	Ophthalmic	Class C
236	Fundus-imaging ophthalmic solid-state laser system	Ophthalmic	Class C
237	Glaucoma supraciliary implant	Ophthalmic	Class C
238	Glaucoma therapy ultrasound system	Ophthalmic	Class C
239	Implantable intraocular pressure monitoring system	Ophthalmic	Class C
240	Implantable iris prosthesis	Ophthalmic	Class C
241	Intracorneal ring	Ophthalmic	Class C
242	Intranasal lacrimal neurostimulator	Ophthalmic	Class C
243	Intraocular pressure-reducing system	Ophthalmic	Class C
244	Ophthalmic clip	Ophthalmic	Class C
245	Ophthalmic cryosurgical system	Ophthalmic	Class C
246	Ophthalmic dye laser system	Ophthalmic	Class C
247	Ophthalmic excimer laser system	Ophthalmic	Class C
248	Ophthalmic noble gas laser system	Ophthalmic	Class C
249	Ophthalmoscope	Ophthalmic	Class C
250	Orbital rim prosthesis	Ophthalmic	Class C
251	Phacoemulsification system	Ophthalmic	Class C
252	Ptosis sling	Ophthalmic	Class C
253	Retinal tack	Ophthalmic	Class C
254	Scleral buckling device	Ophthalmic	Class C
255	Scleral expansion implant	Ophthalmic	Class C
256	Symblepharon ring	Ophthalmic	Class C
257	Vitrectomy system	Ophthalmic	Class C
258	Vitreous body prosthesis	Ophthalmic	Class C
259	Bone densitometer	Interventional and Radiology	Class C
260	Emission computed tomography system.	Interventional and Radiology	Class C
261	Fluorescent scanner	Interventional and Radiology	Class C
262	Nuclear tomography system	Interventional and Radiology	Class C
263	Radionuclide rebreathing system	Interventional and Radiology	Class C
264	Angiographic x-ray system	Interventional and Radiology	Class C
265	Diagnostic x-ray beam-limiting device	Interventional and Radiology	Class C
266	Cine or spot fluorographic x-ray camera	Interventional and Radiology	Class C
267	Electrostatic x-ray imaging system	Interventional and Radiology	Class C
268	Image-intensified fluoroscopic x-ray system	Interventional and Radiology	Class C
269	Non-image- intensified fluoroscopic x-ray system	Interventional and Radiology	Class C
270	Spot-film device	Interventional and Radiology	Class C
271	Mammographic x- ray system	Interventional and Radiology	Class C
272	Full-field digital mammography system	Interventional and Radiology	Class C
273	Photofluorographic x-ray system	Interventional and Radiology	Class C
274	Radiographic film/cassette changer programmer	Interventional and Radiology	Class C
275	Automatic radiographic film processor	Interventional and Radiology	Class C
276	Radiologic table	Interventional and Radiology	Class C
277	Radiological computer-assisted diagnostic software for lesions suspicious of cancer	Interventional and Radiology	Class C
278	Medical image analyzer	Interventional and Radiology	Class C
279	Radiological computer aided triage and notification software	Interventional and Radiology	Class C
280	Full-body MRI system, permanent magnet	Interventional and Radiology	Class C
281	Full-body MRI system, resistive magnet	Interventional and Radiology	Class C
282	Full-body MRI system, superconducting magnet	Interventional and Radiology	Class C
283	Foetal Doppler system	Interventional and Radiology	Class C
284	Blood flowmeter catheter, Doppler	Interventional and Radiology	Class C
285	Polymer Ligating Clips	Dermatology and Plastic Surgery	Class C
286	Implantable ligating clip	Dermatology and Plastic Surgery	Class C
287	Laser surgical instrument for use in general and plastic surgery and in dermatology.	Dermatology and Plastic Surgery	Class C
288	Ultraviolet lamp for dermatologic disorders.	Dermatology and Plastic Surgery	Class C
289	Carbon dioxide laser	Dermatology and Plastic Surgery	Class C
290	Copper vapour laser	Dermatology and Plastic Surgery	Class C
291	Electrosurgical cutting and coagulation device and accessories	Dermatology and Plastic Surgery	Class C
292	Gastroscope, General & Plastic Surgery	Dermatology and Plastic Surgery	Class C
293	General electrosurgical unit	Dermatology and Plastic Surgery	Class C
294	Implantable staple	Dermatology and Plastic Surgery	Class C
295	Laparoscope, General & Plastic Surgery	Dermatology and Plastic Surgery	Class C
296	Antimicrobial endotracheal tube, paediatric	Pediatrics and Neonatology	Class C
297	Breathing circuit gas-flow sensor, reusable	Pediatrics and Neonatology	Class C
298	Breathing circuit gas-flow sensor, single-use	Pediatrics and Neonatology	Class C
299	Cerebral oximeter	Pediatrics and Neonatology	Class C
300	Craniofacial bone screw, non- bioabsorbable, sterile	Pediatrics and Neonatology	Class C
301	Cuff-suction endotracheal tube	Pediatrics and Neonatology	Class C
302	Enteral feeding kit, adult/paediatric, sterile	Pediatrics and Neonatology	Class C
303	Flexible bone nail, non-sterile	Pediatrics and Neonatology	Class C
304	Flexible bone nail, sterile	Pediatrics and Neonatology	Class C
305	Funnel chest remodelling bar	Pediatrics and Neonatology	Class C
306	Growth-correction orthopaedic fixation plate kit	Pediatrics and Neonatology	Class C
307	Infant apnoea monitor	Pediatrics and Neonatology	Class C
308	Infant incubator control unit	Pediatrics and Neonatology	Class C
309	Infant warmer	Pediatrics and Neonatology	Class C
310	Infant/regional-body warmer	Pediatrics and Neonatology	Class C
311	Internal defibrillator electrode, paediatric	Pediatrics and Neonatology	Class C
312	Lacrimal intubation set	Pediatrics and Neonatology	Class C
313	Multifunction cardiac electrode, paediatric	Pediatrics and Neonatology	Class C
314	Neonatal CPAP unit	Pediatrics and Neonatology	Class C
315	Neonatal intensive-care ventilator	Pediatrics and Neonatology	Class C
316	Neonatal physiologic monitoring system	Pediatrics and Neonatology	Class C
317	Neonatal/paediatric heart rate monitoring application software	Pediatrics and Neonatology	Class C
318	Neonatal/paediatric heart rate monitoring hardware	Pediatrics and Neonatology	Class C
319	Nitric oxide delivery unit, system- based	Pediatrics and Neonatology	Class C
320	Open-surgery manual linear cutting stapler, reprocessed	Pediatrics and Neonatology	Class C
321	Open-surgery manual linear cutting stapler, reusable	Pediatrics and Neonatology	Class C
322	Open-surgery manual linear cutting stapler, single-use	Pediatrics and Neonatology	Class C
323	Open-surgery manual linear stapler, reusable	Pediatrics and Neonatology	Class C
324	Open-surgery manual linear stapler, single-use	Pediatrics and Neonatology	Class C
325	Paediatric cardiopulmonary bypass cannula	Pediatrics and Neonatology	Class C
326	Mobile steam washer/disinfector	Pediatrics and Neonatology	Class C
327	Respiratory gas heating wire, infant	Pediatrics and Neonatology	Class C
328	Stationary pneumatic high- frequency ventilator respiration monitor	Pediatrics and Neonatology	Class C
329	Syringe pump	Pediatrics and Neonatology	Class C
330	Transcutaneous intracranial pressure sensor	Pediatrics and Neonatology	Class C
331	Cardiac septostomy catheter, balloon	Pediatrics and Neonatology	Class C
332	Cardiac septostomy catheter, blade	Pediatrics and Neonatology	Class C
333	Conventional infant incubator	Pediatrics and Neonatology	Class C
334	Home BPAP unit	Pediatrics and Neonatology	Class C
335	Oxygen breath analyser	Pediatrics and Neonatology	Class C
336	Respiratory apnoea monitoring system	Pediatrics and Neonatology	Class C
337	Skin transilluminator, battery- powered	Pediatrics and Neonatology	Class C
338	Skin transilluminator, line-powered	Pediatrics and Neonatology	Class C
339	Transport infant incubator	Pediatrics and Neonatology	Class C
340	FerriScan R2-MRI Analysis System	Oncology	Class C
341	Activated-oxygen generator	Oncology	Class C
342	Alternating electric field antimitotic cancer treatment system generator	Oncology	Class C
343	Alternating electric field antimitotic cancer treatment system transducer array	Oncology	Class C
344	Brachytherapy needle	Oncology	Class C
345	Breast 3-D infrared imaging/vascular analysis system	Oncology	Class C
346	Cancer risk assessment interpretive software	Oncology	Class C
347	Cryosurgical set	Oncology	Class C
348	Electro cancer therapy system	Oncology	Class C
349	Electronic clinical breast examination system	Oncology	Class C
350	Endocervical aspirator	Oncology	Class C
351	Balloon kyphoplasty kit	Oncology	Class C
352	Accelerator system chair	Oncology	Class C
353	Accelerator system operator console	Oncology	Class C
354	Accelerator system quality assurance device	Oncology	Class C
355	Anorectal brachytherapy system applicator, manual	Oncology	Class C
356	Anorectal brachytherapy system applicator, remote-afterloading	Oncology	Class C
357	Bile duct brachytherapy system applicator, manual	Oncology	Class C
358	Bile duct brachytherapy system applicator, remote-afterloading	Oncology	Class C
359	Bladder brachytherapy system applicator, remote-afterloading	Oncology	Class C
360	Blood photochemical treatment agent	Oncology	Class C
361	Brachytherapy source spacer	Oncology	Class C
362	Brachytherapy system remote afterloading source safe	Oncology	Class C
363	Brachytherapy system remote- afterloading operator console	Oncology	Class C
364	Breast brachytherapy system applicator, remote-afterloading	Oncology	Class C
365	Breast ultrasound imaging system	Oncology	Class C
366	Bronchial brachytherapy system applicator, manual	Oncology	Class C
367	Bronchial brachytherapy system applicator, remote-afterloading	Oncology	Class C
368	Cervical cone knife	Oncology	Class C
369	Cervical/intrauterine brachytherapy system applicator, remote-afterloading	Oncology	Class C
370	Class-II biological safety cabinet	Oncology	Class C
371	Electroporation therapy system	Oncology	Class C
372	Electroporation therapy system endoscopic applicator	Oncology	Class C
373	Fixed-aperture therapeutic x-ray system collimator	Oncology	Class C
374	Flexible fibreoptic mediastinoscope	Oncology	Class C
375	General-purpose infusion pump, mechanical, single-use	Oncology	Class C
376	Flexible ultrasound colonoscope	Oncology	Class C
377	General-purpose infusion pump, mechanical, reusable	Oncology	Class C
378	Flexible video colonoscope, single- use	Oncology	Class C
379	Medical charged- particle radiation therapy system	Radiotherapy	Class C
380	Absorbable perirectal spacer	Radiotherapy	Class C
381	Applicator for bile duct manual brachytherapy	Radiotherapy	Class C
382	Applicator for bladder manual brachytherapy	Radiotherapy	Class C
383	Applicator for bladder remote afterloading brachytherapy	Radiotherapy	Class C
384	Applicator for brachytherapy bile duct remote afterloading	Radiotherapy	Class C
385	Applicator for brachytherapy Cervical/endometrial remote afterloading	Radiotherapy	Class C
386	Applicator for brachytherapy non- central circulatory general-purpose manual	Radiotherapy	Class C
387	Applicator for brachytherapy non- central circulatory general-purpose remote afterloading	Radiotherapy	Class C
388	Applicator for bronchial manual brachytherapy applicator	Radiotherapy	Class C
389	Applicator for bronchial remote afterloading brachytherapy	Radiotherapy	Class C
390	Applicator for esophagus manual brachytherapy	Radiotherapy	Class C
391	Applicator for esophagus remote afterloading brachytherapy	Radiotherapy	Class C
392	Applicator for eye manual brachytherapy	Radiotherapy	Class C
393	Applicator for manual cervical/endometrial brachytherapy	Radiotherapy	Class C
394	Applicator for manual rectal/anal brachytherapy	Radiotherapy	Class C
395	Applicator for nasopharynx manual brachytherapy	Radiotherapy	Class C
396	Applicator for nasopharynx remote afterloading brachytherapy	Radiotherapy	Class C
397	Applicator for neck manual brachytherapy	Radiotherapy	Class C
398	Applicator for neck remote afterloading brachytherapy	Radiotherapy	Class C
399	Applicator for pancreas manual brachytherapy	Radiotherapy	Class C
400	Applicator for pancreas remote afterloading brachytherapy	Radiotherapy	Class C
401	Applicator for prostate manual brachytherapy	Radiotherapy	Class C
402	Applicator for prostate remote afterloading brachytherapy	Radiotherapy	Class C
403	Applicator for rectal/anal remote afterloading brachytherapy	Radiotherapy	Class C
404	Applicator for tongue manual brachytherapy	Radiotherapy	Class C
405	Applicator for tongue remote afterloading brachytherapy	Radiotherapy	Class C
406	Applicator for vaginal manual brachytherapy	Radiotherapy	Class C
407	Applicator for vaginal remote afterloading brachytherapy	Radiotherapy	Class C
408	Bile duct brachytherapy system applicator, remote- afterloading	Radiotherapy	Class C
409	Bladder brachytherapy system applicator, manual	Radiotherapy	Class C
410	Brachytherapy needle	Radiotherapy	Class C
411	Brachytherapy radionuclide phantom, anthropomorphic	Radiotherapy	Class C
412	Brachytherapy system remote afterloading source safe	Radiotherapy	Class C
413	Brachytherapy system remote afterloading source transfer tube	Radiotherapy	Class C
414	Brain brachytherapy system applicator, remote-afterloading	Radiotherapy	Class C
415	Breast ductography cannula	Radiotherapy	Class C
416	Conformal Brachytherapy Source	Radiotherapy	Class C
417	High-frequency hyperthermia system	Radiotherapy	Class C
418	Living tissue radiotherapy system	Radiotherapy	Class C
419	Medical neutron radiation therapy system	Radiotherapy	Class C
420	MOSFET radiation therapy dosimetry system	Radiotherapy	Class C
421	Non-central circulatory manual brachytherapy therapeutic radionuclide system	Radiotherapy	Class C
422	Non-central circulatory permanent implant manual brachytherapy therapeutic radionuclide source	Radiotherapy	Class C
423	Non-central circulatory remote afterloading brachytherapy therapeutic radionuclide source	Radiotherapy	Class C
424	Non-central circulatory remote afterloading brachytherapy therapeutic radionuclide system	Radiotherapy	Class C
425	Non-central circulatory temporary placement manual brachytherapy therapeutic radionuclide source	Radiotherapy	Class C
426	Nuclear medicine positron emission tomography system	Radiotherapy	Class C
427	Patient positioning device for breast diagnostic imaging and radiotherapy	Radiotherapy	Class C
428	Patient positioning device for extremity diagnostic imaging and radiotherapy	Radiotherapy	Class C
429	Post Breast Biopsy Hemostatic Breast Compression Device	Radiotherapy	Class C
430	Powered radiation therapy patient support assembly	Radiotherapy	Class C
431	Radiation therapy beam-shaping block	Radiotherapy	Class C
432	Radiation therapy simulation system	Radiotherapy	Class C
433	Radio-frequency ablation system	Radiotherapy	Class C
434	Radio-frequency lesion generator system with probe	Radiotherapy	Class C
435	Radionuclide brachytherapy source	Radiotherapy	Class C
436	Radionuclide radiation therapy system.	Radiotherapy	Class C
437	Radionuclide source for remote irradiation therapy	Radiotherapy	Class C
438	Radionuclide system contour detector for remote irradiation therapy	Radiotherapy	Class C
439	Real-time position management respiratory gating system, optical	Radiotherapy	Class C
440	Rectal balloon for prostate immobilization	Radiotherapy	Class C
441	Remote controlled radionuclide applicator system	Radiotherapy	Class C
442	Stereotactic radiotherapy accelerator system	Radiotherapy	Class C
443	X-ray CT system for radiotherapy planning	Radiotherapy	Class C
444	X-ray radiation therapy system	Radiotherapy	Class C
445	X-ray/CT combined linear accelerator system	Radiotherapy	Class C
446	X-ray/CT combined particle radiotherapy equipment	Radiotherapy	Class C
447	Automated peritoneal dialysis system	Nephrology and Renal Care	Class C
448	Dialysis apheresis unit, Therapeutic	Nephrology and Renal Care	Class C
449	Disposable Hemoperfusion Cartridge	Nephrology and Renal Care	Class C
450	Electrical conductivity measuring instrument for dialysis fluid	Nephrology and Renal Care	Class C
451	Haemodialyzer reprocessing system	Nephrology and Renal Care	Class C
452	Haemofilters	Nephrology and Renal Care	Class C
453	Hemodiafiltration system	Nephrology and Renal Care	Class C
454	Hollow-fibre haemodialysis dialyser	Nephrology and Renal Care	Class C
455	Kidney donor-organ preservation/transport system	Nephrology and Renal Care	Class C
456	Kidney stone filter	Nephrology and Renal Care	Class C
457	Multi-patient dialysis fluid delivery system	Nephrology and Renal Care	Class C
458	Peritoneal dialysis catheter adaptor	Nephrology and Renal Care	Class C
459	Peritoneal dialysis dialysate warmer	Nephrology and Renal Care	Class C
460	Reverse Osmosis Unit (for dialysis)	Nephrology and Renal Care	Class C
461	Haemodialysis concentrate	Nephrology and Renal Care	Class C
462	Haemodialysis conductivity standard solution	Nephrology and Renal Care	Class C
463	Haemodialysis system air/foam detector	Nephrology and Renal Care	Class C
464	Haemodialysis system bicarbonate mixer	Nephrology and Renal Care	Class C
465	Haemodialysis system central monitor	Nephrology and Renal Care	Class C
466	Haemodialysis system plasma filtration unit	Nephrology and Renal Care	Class C
467	Peritoneal dialysis system dialysate filter	Nephrology and Renal Care	Class C
468	Sodium carbonate haemodialysis system cleaning cartridge	Nephrology and Renal Care	Class C
469	Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals	Software	Class C
470	Coronary Vascular Physiologic Simulation Software	Software	Class C
471	Angiographic Coronary Vascular Physiologic Simulation Software	Software	Class C
472	Software For Visualization Of Vascular Anatomy And Intravascular Devices	Software	Class C
473	Orthodontic Software	Software	Class C
474	Dental Abutment Design Software For Dental Laboratory	Software	Class C
475	Neuropsychiatric Interpretative Electroencephalogr aph Assessment Aid	Software	Class C
476	Normalizing Quantitative Electroencephalogr aph Software	Software	Class C
477	Index-Generating Electroencephalogr aph Software	Software	Class C
478	Source Localization Software For Electroencephalogr aph Or Magnetoencephalo graph	Software	Class C
479	Automatic Event Detection Software For Polysomnograph With Electroencephalogr aph	Software	Class C
480	Automatic Event Detection Software For Full-Montage Electroencephalogr aph	Software	Class C
481	Computerized Cognitive Assessment Aid For Concussion	Software	Class C
482	Computerized Behavioral Therapy Device For Psychiatric Disorders	Software	Class C
483	Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid	Software	Class C
484	Device, Fertility Diagnostic, Contraceptive, Software Application	Software	Class C
485	Diabetic Retinopathy Detection Device	Software	Class C
486	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Software	Class C
487	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Software	Class C
488	Burn Resuscitation Decision Support Software	Software	Class C
489	Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types	Software	Class C
490	Software for peritoneal dialysis treatment	Software	Class C
491	Software for radiation planning	Software	Class C
492	Software for radiotherapy QAQC planning	Software	Class C
493	Software for ophthalmic surgery treatment planning	Software	Class C
494	Software for active implanted device control	Software	Class C
495	Information collating software for radiotherapy	Software	Class C
496	Software for gene variants analysis (for cancer genome profiling)	Software	Class C
497	Supporting software for differential diagnosis with endoscopic imaging	Software	Class C

Class B Medical Devices by Speciality Category

Here is a quick-reference breakdown of all 497 Class C devices organized by medical speciality category:

Medical Speciality Category	No. of Class B Devices
Radiotherapy	68
Pediatrics and Neonatology	44
Neurological	40
Oncology	39
Ophthalmic	37
Gastroenterology	36
Software	29
Interventional and Radiology	26
ENT (Ear, Nose & Throat)	24
Dental	22
Nephrology and Renal Care	22
General Hospital	19
Obstetrical and Gynaecological (OG)	16
Pain Management	14
Anesthesiology	13
Urology	12
Cardiovascular	11
Dermatology and Plastic Surgery	11
Operation Theatre (OT)	7
Respiratory	7

Documents Required for CDSCO Class C Medical Device License

The documentation requirement for a Class B license is more comprehensive than Class A registration. Here is the complete checklist, split by applicant type:

Documents for Indian Manufacturers (Manufacturing License)

Document	Requirement / Notes
Application Form MD-3 (Form 27D)	Duly filled online application for manufacturing license on the CDSCO Sugam portal
Proof of Business Registration	Certificate of Incorporation / Partnership Deed / GST Certificate of the manufacturing entity
Site Master File (SMF)	Detailed description of manufacturing facility, equipment, layout, and quality systems
Schedule M Compliance Certificate	Declaration or third-party audit confirming GMP compliance for medical devices
ISO 13485 Quality Management System Certificate	Preferred; some states/devices may require it as mandatory
Device Technical Documentation	Device description, intended use, specifications, design summary, risk assessment (ISO 14971)
Performance/Safety Test Reports	Lab reports from accredited lab confirming device meets applicable safety standards (IS/IEC/ISO)
List of Devices Proposed to Be Manufactured	Specific device names as listed in the official CDSCO Class C classification
Details of Technically Qualified Personnel	Qualifications and experience of key technical staff involved in manufacturing
Manufacturing Process Flow Chart	Step-by-step manufacturing process for each device type
Declaration of Conformity	Signed declaration that the device meets applicable safety and performance standards
Power of Attorney / Authorization Letter	If a consultant or authorized person is filing on behalf of the company

Additional Documents for Importers (Import License)

Document	Requirement / Notes
Application Form MD-15 (Import)	Duly filled import license application on the CDSCO Sugam portal
Free Sale Certificate (FSC)	Valid FSC from the competent authority of the country of manufacture (apostilled if required)
CE Mark / USFDA 510(k) / TGA Certificate	Regulatory approval in country of origin from a recognized regulatory authority
Indian Authorized Agent (IAA) Agreement	Signed agreement between foreign manufacturer and registered Indian agent
IAA Registration Certificate	Current CDSCO registration of the Indian Authorized Agent
Foreign Manufacturer's GMP Certificate	ISO 13485 or equivalent GMP certificate from accredited certification body
Product Labeling in English	Label compliant with MDR 2017 Schedule III requirements
Device Technical Documentation (Summary)	Design description, intended use, classification rationale, basic safety/performance summary
Performance Test Reports	Test reports from NABL-accredited or equivalent foreign labs (ILAC-MRA signatories accepted)
Undertaking from Foreign Manufacturer	Signed undertaking confirming responsibility for product quality and compliance

Document for CDSCO Class C Medical Devices

Step-by-Step Process: How to Get a CDSCO Class C License in 2026

CDSCO's Sugam portal has made the entire licensing process digital. Here is the exact process for 2026, step by step:

Step 1: Confirm Your Device is Class B

Cross-reference your product name against the official CDSCO Class C list (Annexure II)
Verify the intended use matches the CDSCO description — small differences can cause classification disputes
If unsure, consult a CDSCO-registered Regulatory Affairs consultant or raise a classification query with CDSCO directly

Step 2: Achieve GMP / ISO 13485 Compliance

For manufacturers: Ensure your facility complies with Schedule M of MDR 2017 (GMP for medical devices)
Get your ISO 13485 QMS certification from an accredited certification body (NABCB-accredited preferred)
Conduct an internal gap assessment against MDR 2017 Schedule M requirements before filing
For importers: Confirm your foreign manufacturer has valid ISO 13485 certification

Step 3: Prepare Complete Technical Documentation

Compile the full device technical file: design, specifications, risk management (ISO 14971), test reports
Ensure all performance and safety test reports are from NABL-accredited or ILAC-recognized labs
Prepare the Site Master File (SMF) describing your manufacturing facility in detail
Draft the Declaration of Conformity and get it signed by the authorized signatory

Step 4: Register and Create Profile on CDSCO Sugam Portal

Visit sugam in and register as 'Manufacturer' or 'Importer'
Complete company profile setup with GSTIN, PAN, authorized signatory details, and site address
For importers: Ensure IAA profile is already set up and linked to the foreign manufacturer's account

Step 5: File Application (Form MD-3 / MD-15) and Pay Fee

Log in to the Sugam portal and select 'Apply for Class B Manufacturing License' or 'Apply for Import License'
Fill Form MD-3 (manufacturing) or MD-15 (import) accurately — device names must match the official classification list exactly
Upload all documents in prescribed format (PDF, file size limits apply)
Pay the prescribed fee online through the payment gateway
Save and note your application reference number for tracking

Step 6: CDSCO Review, Queries, and Inspection

CDSCO officers scrutinize your application — document completeness is checked first
For manufacturing licenses: A facility inspection by a CDSCO/State Drug Controller officer is typically conducted
If queries are raised on the portal, respond with accurate documents within the stipulated time
Never respond to queries by email — use only the Sugam portal for official communication
Inspection observations must be addressed and compliance confirmation submitted

Step 7: License Issuance

Upon successful review and inspection, CDSCO issues the Manufacturing License (Form MD-5) or Import License (Form MD-17)
Download the digital license certificate from the Sugam portal — it is legally valid
The license number must be printed on device labels and referenced in all regulatory correspondence
Typical timeline: 90–180 days from application submission for manufacturing licenses (faster for importers if documents are complete)

2026 Update: CDSCO has introduced risk-based inspections for Class B manufacturing licenses. Facilities with ISO 13485 certification and complete documentation are increasingly receiving expedited review. Investing in QMS certification before applying can significantly reduce your licensing timeline.

CDSCO Fees for Class B Medical Device License

The prescribed fees for Class C medical device licensing are set under the Second Schedule of MDR 2017. Here is the current fee structure:

License Type / Applicant	Fee (INR)
Manufacturing License — Small Manufacturer (Turnover ≤ ₹10 crore)	₹2,500 per device
Manufacturing License — Medium Manufacturer (Turnover ₹10–250 crore)	₹5,000 per device
Manufacturing License — Large Manufacturer (Turnover > ₹250 crore)	₹10,000 per device
Import License — Per Device (Importer)	₹5,000 per device
Amendment to Existing License	₹2,500 – ₹5,000 (depending on amendment type)
License Renewal (per device)	Same as initial licensing fee
Late Renewal Penalty	Additional surcharge as per MDR 2017 Second Schedule
Inspection Fee (State-Level, where applicable)	Varies by state; typically ₹5,000 – ₹25,000 per inspection

Always Verify Fees: Fees are subject to revision by the Ministry of Health. Before submitting your application, verify the current fee schedule on cdsco.gov.in or the Sugam portal. Third-party information (including this guide) may not reflect the latest amendments immediately.

Validity and Renewal of CDSCO Class C Device License

Your Class B device license has defined validity — missing the renewal window can disrupt your entire supply chain. Here is what you need to know:

Aspect	Details
License Validity Period	Manufacturing License: Valid for 3 years from date of issue. Import License: Valid for 3 years from date of issue.
Renewal Application Deadline	Apply for renewal at least 30 days before the license expiry date. Early renewal is recommended (3–6 months in advance for manufacturing licenses due to inspection requirements).
Renewal Process	File renewal application via Sugam portal. Submit updated documents if any changes have occurred. Manufacturing facilities may require re-inspection.
Consequence of Expiry Without Renewal	Selling or distributing Class B devices with an expired license is a direct violation of MDR 2017. Products can be seized and legal action can be initiated.
Change in Device List / Scope	Adding new devices to an existing license requires an amendment application and additional fees.
Change in Manufacturing Address	Requires a fresh inspection and amendment to the license. Cannot be done retrospectively.
Change in Company Name / Ownership	Must be disclosed to CDSCO within 30 days. Amendment application required.
Voluntary Surrender of License	If you stop manufacturing/importing, file a voluntary surrender to avoid compliance obligations.

Key Benefits of Getting a CDSCO Class C License

A valid CDSCO Class C license is not just a legal requirement — it actively drives your business forward:

1. Unrestricted Legal Market Access Across India

A Class B license issued by CDSCO gives you the legal right to manufacture, import, sell, and distribute your medical devices anywhere in India. Without it, every sale is a liability.

2. Gateway to Government and Institutional Tenders

Hospitals, government health programs (PM-ABHIM, Ayushman Bharat), PSUs, and state procurement portals (GeM) mandate valid CDSCO licenses for Class B devices. A license opens you to India's massive public healthcare procurement market.

3. Enhanced Credibility with Private Hospital Chains

Major hospital networks and medical device distributors now conduct compliance verification before onboarding suppliers. A valid Class B license is often the first check. It signals that your products meet Indian regulatory standards.

4. Export Facilitation

CDSCO issues Free Sale Certificates (FSC) only to licensed manufacturers. If you want to export your Class B device, your CDSCO manufacturing license is the prerequisite for getting an FSC — which most export markets require.

5. Protection Against Enforcement Actions

CDSCO and state drug controllers conduct market surveillance checks. With a valid Class B license, your products can withstand regulatory scrutiny. Without one, a single inspection can lead to product seizure, factory closure, and reputational damage.

6. Platform for Growth to Higher-Class Devices

Once your GMP infrastructure and QMS are established for Class B, upgrading to Class C or D licensing becomes structurally easier. Your Class B license is a foundation investment for your company's regulatory capability.

Common Mistakes That Delay or Reject Class B License Applications

After reviewing common applicant error patterns, here are the key pitfalls to avoid:

Misclassifying the device — always confirm your device is in the Class B list before applying; wrong classification leads to rejection
Using device names that don't exactly match the official CDSCO classification list — even slight variations cause technical deficiencies
Submitting ISO 13485 certificates that are expired or not NABCB/accredited body certified
Incomplete Site Master File (SMF) — missing equipment lists, facility layouts, or GMP procedures are the most common deficiency reasons
Test reports from non-NABL or non-ILAC-recognized labs — these are not accepted and result in queries
Not responding to CDSCO queries within the stipulated time — ignored queries lead to automatic rejection
Importers not having IAA agreement notarized or apostilled as required
Filing for manufacturing license before the facility is GMP-ready — inspection failure is costly in time and money
Applying for all devices in one license without confirming each device is in the Class B classification list
Not updating CDSCO within 30 days of company name, address, or ownership changes

Class A vs Class B — Key Regulatory Differences at a Glance

Many businesses confuse Class A and Class B requirements. Here is a clear comparison:

Regulatory Aspect	Class A (Non-Sterile, Non-Measuring) vs Class B
Registration vs License	Class A: Registration only (Chapter IIIB) \| Class B: Full license required (Chapter IV)
Facility Inspection	Class A: Not required \| Class B: Mandatory for manufacturing license
ISO 13485 Requirement	Class A: Optional but recommended \| Class B: Expected, often mandatory
Technical Documentation	Class A: Basic device description \| Class B: Full technical file including risk management and test reports
Clinical Evidence	Class A: Not required \| Class B: May be required for specific device types
Fees	Class A: ₹1,000–₹5,000 per device \| Class B: ₹2,500–₹10,000 per device
Processing Time	Class A: 30–45 working days \| Class B: 90–180 days (including inspection)
Validity	Class A: 5 years \| Class B: 3 years
Post-Market Obligations	Class A: Minimal \| Class B: Periodic safety reporting, vigilance system required

Conclusion — Get Your Class B License Right the First Time

CDSCO registration for Class C medical devices is one of the most important regulatory steps any medical device company in India will undertake. Done right, it opens doors to a $10+ billion Indian medical device market, government tenders, institutional sales, and export opportunities. Done wrong — or skipped entirely — it exposes your business to product seizures, legal liability, and reputational damage.

The 497 Class C devices listed in this guide are directly sourced from CDSCO's official classification. The processes, fees, and timelines described are based on MDR 2017 and CDSCO's current operational practices. If your device is on this list, there is no shortcut — you need a valid CDSCO license.

Start by confirming your device classification, get your GMP and QMS in order, and file a complete application through the Sugam portal. A well-prepared, first-time-correct application is the fastest path to your Class B license.

Frequently Asked Questions

What is a Class C medical device in India under CDSCO?

A Class C medical device under MDR 2017 is a moderate-to-high risk device. Examples include aerosol face masks, dental chairs, bronchoscopy tubes, respiratory monitoring systems, ophthalmic instruments, and gastroenterology devices. These devices require a full CDSCO manufacturing or import license — not just registration like Class A.

Is a separate license needed for each Class B device?

No — a single manufacturing or import license can cover multiple Class B devices, provided all devices are clearly listed in the application and are within the same manufacturing scope. Each device must be individually listed and the applicable fee paid for each device on the license.

How long does it take to get a CDSCO Class C manufacturing license?

Typically 90 to 180 working days from application submission — provided all documents are complete and the manufacturing facility passes inspection on the first attempt. Incomplete applications, unanswered queries, or failed inspections can extend this significantly. Import licenses are usually faster — 60 to 90 days if documentation is in order.

Can I import and sell a Class B device in India without a license?

Absolutely not. Importing or selling a Class B device in India without a valid CDSCO import license is a direct violation of MDR 2017. Unregistered devices can be seized at customs, fines can be imposed, and persistent violations can lead to criminal prosecution. The Indian Authorized Agent (IAA) is the legal face of the foreign manufacturer in India.

Is ISO 13485 mandatory for Class B device licensing?

While MDR 2017 does not explicitly make ISO 13485 mandatory for Class B devices, in practice, CDSCO and state drug controllers expect evidence of a functional Quality Management System during inspections. Most companies obtaining Class B licenses have ISO 13485 certification. It significantly reduces inspection risk and speeds up processing.

What is Form MD-3 and where is it used?

Form MD-3 is the application form for a Class C medical device manufacturing license under MDR 2017. It is filed online through the CDSCO Sugam portal. The form captures applicant details, manufacturing site information, list of devices, and declarations. For import licenses, the relevant form is Form MD-15.

What happens during a CDSCO facility inspection for Class B?

A CDSCO officer (or delegated State Drug Controller officer) visits your manufacturing facility to verify GMP compliance, infrastructure, equipment, records, and quality systems. They check whether your actual facility matches what was described in your Site Master File. Non-conformances found during inspection must be addressed before the license is issued.

Can a startup company apply for a Class C medical device license?

Yes. CDSCO does not have a minimum revenue or age-of-business requirement for Class B licensing. However, the startup must have a GMP-compliant manufacturing facility, qualified technical personnel, and complete technical documentation. Many startups partner with contract manufacturers (who already have licenses) while setting up their own facilities.

What is the penalty for selling unlicensed Class B devices in India?

Under Section 26A and related provisions of the Drugs and Cosmetics Act (as applicable to medical devices), selling unlicensed Class B devices can result in product seizure, fines up to ₹5 lakh or more, and imprisonment of up to 5 years for repeat or serious violations. CDSCO and state drug controllers actively conduct market surveillance for unlicensed medical devices.

When should I renew my Class B license, and what happens if I miss the deadline?

Apply for renewal at least 30 days before expiry — and ideally 3–6 months in advance for manufacturing licenses (which may require re-inspection). If your license expires before renewal is granted, you are technically not authorized to continue manufacturing or selling during the gap period. CDSCO may grant a grace period in certain cases, but this cannot be relied upon. Never let your license lapse.

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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