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CDSCO Registration for Class B Medical Devices: The India’s Class B Medical Device Licensing — Device List, Process, Documents, & Fees

CDSCO Registration for Class B Medical Devices
  • CDSCO Registration For Class B Medical Devices 751 devices classified as Class B — 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 device 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 B Medical Device Registration?

If you manufacture, import, or plan to sell Class B medical devices in India, you already know the stakes. Class B sits in the middle 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 risk and are subject to mandatory licensing under the Medical Devices Rules (MDR), 2017.

CDSCO Logo

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.

This guide gives you everything: the complete Class B device list (all 751 devices), the exact licensing process for 2026, documents required, fee structure, validity, renewal steps, and answers to the 10 most commonly asked questions — with zero guesswork.

Official Source: The 751 Class B 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 ClassRisk 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 hereLow-to-moderate risk. Manufacturing license + import license required under Chapter IV. Clinical performance evidence may be required for some devices.
Class CModerate-to-high risk. Stricter licensing, clinical investigation data, notified body involvement.
Class DHighest risk (life-sustaining, implantable). Most rigorous regulatory pathway, clinical evidence mandatory.
Risk based classified for CDSCO

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 Registration For Class B Medical Device?

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

  • Indian manufacturers producing Class B 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 B Device License

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

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

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

The table below is the complete, official CDSCO Class B medical device list sourced directly from Annexure II of CDSCO's classification document. This covers all 751 Class B 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 NameMedical CategoryCDSCO Class
1Aerosol face maskAnesthesiologyClass B
2Aerosol inhalation monitorAnesthesiologyClass B
3Airway temperature monitoring systemAnesthesiologyClass B
4Anaesthesia breathing circuitAnesthesiologyClass B
5Anaesthesia depth monitorAnesthesiologyClass B
6Anaesthesia information systemAnesthesiologyClass B
7Anaesthesia workstation gas scavengerAnesthesiologyClass B
8Anaesthetic gas absorption/desorption deviceAnesthesiologyClass B
9Artificial airway washing/disinfection jarAnesthesiologyClass B
10Brachial plexus anaesthesia kitAnesthesiologyClass B
11Breathing circuit gas- sampling/monitoring setAnesthesiologyClass B
12Breathing circuit washer/disinfectorAnesthesiologyClass B
13Bronchoscopy tubeAnesthesiologyClass B
14CPAP/BPAP nasal maskAnesthesiologyClass B
15CPAP/BPAP oral maskAnesthesiologyClass B
16Electronic oesophageal stethoscopeAnesthesiologyClass B
17Endobronchial tubeAnesthesiologyClass B
18Endotracheal secretion monitoring systemAnesthesiologyClass B
19Helium/oxygen breathing gas mixerAnesthesiologyClass B
20Inhalational analgesia unitAnesthesiologyClass B
21Intracardiac oximeterAnesthesiologyClass B
22Intravascular blood gas/pH monitoring systemAnesthesiologyClass B
23Intravascular oximeterAnesthesiologyClass B
24Invasive arterial pressure cardiac output/oximetry monitorAnesthesiologyClass B
25Laryngectomy tubeAnesthesiologyClass B
26Laryngotracheal anaesthesia applicatorAnesthesiologyClass B
27Medicine chamber spacerAnesthesiologyClass B
28Microbial medical gas filterAnesthesiologyClass B
29Neonatal chest percussorAnesthesiologyClass B
30Nitric oxide delivery unitAnesthesiologyClass B
31Non-heated respiratory humidifierAnesthesiologyClass B
32Oxygen/air breathing gas mixerAnesthesiologyClass B
33Peak flow meterAnesthesiologyClass B
34Pleural manometerAnesthesiologyClass B
35Pneumatic chest percussorAnesthesiologyClass B
36Pressure algometer/aesthesiometerAnesthesiologyClass B
37Pulmonary function analysis systemAnesthesiologyClass B
38Pulse Co-oximeterAnesthesiologyClass B
39Respiration monitorAnesthesiologyClass B
40Respiratory oxygen monitorAnesthesiologyClass B
41Respiratory oxygen therapy monitor/regulatorAnesthesiologyClass B
42Retrograde endotracheal intubation kitAnesthesiologyClass B
43Saddle block anaesthesia kitAnesthesiologyClass B
44Ultrasonic respiratory humidifierAnesthesiologyClass B
45Vacuum-assisted airway secretion- clearing systemAnesthesiologyClass B
46Venturi oxygen face maskAnesthesiologyClass B
47Vortex oxygen face maskAnesthesiologyClass B
48Acupuncture electrical stimulation systemPain ManagementClass B
49Acupuncture kitPain ManagementClass B
50Acupuncture point detectorPain ManagementClass B
51Analgesic PENS systemPain ManagementClass B
52Analgesic TENS systemPain ManagementClass B
53Arthritis TENS systemPain ManagementClass B
54Arthritis transcutaneous electrical joint stimulation systemPain ManagementClass B
55Bed/chair electric massagerPain ManagementClass B
56Blue/red/infrared phototherapy lampPain ManagementClass B
57Circulating-fluid thermal therapy systemPain ManagementClass B
58Cold-air therapy unitPain ManagementClass B
59Deep-tissue electromagnetic stimulation systemPain ManagementClass B
60Electric pad localized-body heating systemPain ManagementClass B
61Endothermic cold therapy packPain ManagementClass B
62Exothermic heat therapy packPain ManagementClass B
63Foot bathPain ManagementClass B
64Heat therapy gelPain ManagementClass B
65Hydrotherapy bath/tankPain ManagementClass B
66Inflatable hot/cold therapy pack/electric pumpPain ManagementClass B
67Inhalational analgesia unitPain ManagementClass B
68Interferential electrical stimulation systemPain ManagementClass B
69Intervertebral disc prolapse therapy packPain ManagementClass B
70Musculoskeletal infrared phototherapy unitPain ManagementClass B
71Physical therapy paraffin wax bathPain ManagementClass B
72Short-wave diathermy treatment systemPain ManagementClass B
73Static magnetic back/spine insulatorPain ManagementClass B
74Static magnetic elbow orthosisPain ManagementClass B
75Static magnetic foot arch orthosisPain ManagementClass B
76Static magnetic joint insulatorPain ManagementClass B
77Static magnetic knee orthosisPain ManagementClass B
78Static magnetic lumbar spine orthosisPain ManagementClass B
79Static magnetic shoulder orthosisPain ManagementClass B
80Static magnetic thoracic spine orthsosisPain ManagementClass B
81Wearable cervical spine traction devicePain ManagementClass B
82Wearable lumbar spine traction devicePain ManagementClass B
83Cardiac monitor (including cardiotachometer and rate alarm)CardiovascularClass B
84Apex cardiograph (vibrocardiograph).CardiovascularClass B
85Echocardiograph.CardiovascularClass B
86Electrocardiograph.CardiovascularClass B
87Vascular clipCardiovascularClass B
88Vena cava clip.CardiovascularClass B
89Pacemaker generator function analyzer.CardiovascularClass B
90Cardiovascular permanent or temporary pacemaker electrode.CardiovascularClass B
91Pacemaker electrode function tester.CardiovascularClass B
92Endomyocardial biopsy device.CardiovascularClass B
93Cardiopulmonary bypass bubble detector.CardiovascularClass B
94Cardiopulmonary bypass vascular catheter, cannula, or tubingCardiovascularClass B
95Cardiopulmonary bypass heart-lung machine console.CardiovascularClass B
96Cardiopulmonary bypass heat exchanger.CardiovascularClass B
97Cardiopulmonary bypass temperature controller.CardiovascularClass B
98Cardiopulmonary bypass cardiotomy suction line bloodCardiovascularClass B
99Intraluminal artery stripper.CardiovascularClass B
100Agar dental impression materialDentalClass B
101Alginate dental impression materialDentalClass B
102Composite dental impression materialDentalClass B
103Dental crown, polymerDentalClass B
104Dental crown/bridge resin, temporaryDentalClass B
105Dental crown/bridge, temporaryDentalClass B
106Dental crown, metal/ceramicDentalClass B
107Dental crown, metal/polymerDentalClass B
108Dental bone particle collectorDentalClass B
109Dental suction systemDentalClass B
110Dental suction system pumpDentalClass B
111Polyether dental impression materialDentalClass B
112Polysulfide dental impression materialDentalClass B
113Silicone dental impression materialDentalClass B
114Dental suction system disinfection control unitDentalClass B
115Zinc polycarboxylate dental cementDentalClass B
116Preformed dental crown, permanentDentalClass B
117Preformed dental crown, temporaryDentalClass B
118Zinc phosphate dental cementDentalClass B
119Dental anaesthesia injection kitDentalClass B
120Dental anaesthesia syringe cartridgeDentalClass B
121Bite registration rimDentalClass B
122Bite registration rim waxDentalClass B
123Bite registration rim wax, plateDentalClass B
124Ceramic artificial teethDentalClass B
125Adenotome bladeDentalClass B
126AudiometerDentalClass B
127OtoscopeDentalClass B
128Auditory evoked-potential graphic recorderDentalClass B
129Behind-the-ear air-conduction hearing aidDentalClass B
130Behind-the-ear air-conduction tinnitus maskerDentalClass B
131Ear wickDentalClass B
132ElectroglottographDentalClass B
133ENT chair, electricDentalClass B
134ENT chair, mechanicalDentalClass B
135ENT shaver systemDentalClass B
136ENT surgical microscopeDentalClass B
137Evoked-potential audiometerDentalClass B
138Flexible fibreoptic nasopharyngolaryngoscopeDentalClass B
139Flexible fibreoptic nasopharyngoscopeDentalClass B
140Flexible fibreoptic rhinoscopeDentalClass B
141Flexible fibreoptic sinoscopeDentalClass B
142Flexible video antroscopeDentalClass B
143Impedance audiometerDentalClass B
144ENT Nasal snareDentalClass B
145Otoscope, endoscopicDentalClass B
146Otoscope, directDentalClass B
147Soft-tissue surgical forceps, alligatorDentalClass B
148Epistaxis balloonDentalClass B
149Eustachian tube balloon dilation systemDentalClass B
150Esophagoscope (flexible or rigid)DentalClass B
151Mediastinoscope and accessoriesDentalClass B
152LaryngostroboscopeDentalClass B
153Powered nasal irrigatorDentalClass B
154Antistammering deviceDentalClass B
155Wireless air-conduction hearing aidDentalClass B
156Hearing aid calibrator and analysis systemDentalClass B
157Master hearing aidDentalClass B
158Battery-powered artificial larynxDentalClass B
159Nasal dilatorDentalClass B
160Absorbent enteric stomal dressingGastroenterologyClass B
161Anal fistula circular cutterGastroenterologyClass B
162Anoscope, reusableGastroenterologyClass B
163Anoscope, single-useGastroenterologyClass B
164Barium enema catheterGastroenterologyClass B
165Biliary manometric catheterGastroenterologyClass B
166Catheter-balloon inflator, reprocessedGastroenterologyClass B
167Catheter-balloon inflator, reusableGastroenterologyClass B
168Catheter-balloon inflator, single-useGastroenterologyClass B
169Cholangiopancreatography catheter, reusableGastroenterologyClass B
170Cholangiopancreatography catheter, single-useGastroenterologyClass B
171Colonic endoscopy cuffGastroenterologyClass B
172Colonic lavage kit, surgicalGastroenterologyClass B
173Colonoscope positioning sleeveGastroenterologyClass B
174Colonoscope stiffenerGastroenterologyClass B
175Colorectal sizerGastroenterologyClass B
176Common bile duct dilatorGastroenterologyClass B
177Endoscope tissue removal capGastroenterologyClass B
178Endoscopic biopsy valve, non-sterileGastroenterologyClass B
179Endoscopic biopsy valve, sterileGastroenterologyClass B
180Endoscopic cutting stapler connectorGastroenterologyClass B
181Endoscopic electrosurgical biopsy/resection kit, full-thicknessGastroenterologyClass B
182Endoscopic electrosurgical biopsy/resection kit, partial-thicknessGastroenterologyClass B
183Endoscopic electrosurgical electrode/submucosal lift needleGastroenterologyClass B
184Endoscopic gastrointestinal stenosis dilatorGastroenterologyClass B
185Endoscopic motorized cutting stapler, reusableGastroenterologyClass B
186Endoscopic motorized cutting stapler, single-useGastroenterologyClass B
187Endoscopic needleless submucosal lift catheterGastroenterologyClass B
188Endoscopic overtube, reusableGastroenterologyClass B
189Endoscopic spray catheterGastroenterologyClass B
190Externally-propelled flexible video colonoscopeGastroenterologyClass B
191Flexible fibreoptic choledochoscopeGastroenterologyClass B
192Flexible fibreoptic colonoscopeGastroenterologyClass B
193Flexible fibreoptic duodenoscopeGastroenterologyClass B
194Flexible fibreoptic enteroscopeGastroenterologyClass B
195Flexible fibreoptic gastroduodenoscopeGastroenterologyClass B
196Flexible fibreoptic gastroscopeGastroenterologyClass B
197Flexible fibreoptic oesophagoscopeGastroenterologyClass B
198Flexible fibreoptic pancreatoscopeGastroenterologyClass B
199Flexible fibreoptic sigmoidoscopeGastroenterologyClass B
200Flexible ultrasound colonoscopeGastroenterologyClass B
201Flexible ultrasound duodenoscopeGastroenterologyClass B
202Flexible ultrasound gastroduodenoscopeGastroenterologyClass B
203Flexible video choledochoscopeGastroenterologyClass B
204Flexible video choledochoscope, single-useGastroenterologyClass B
205Flexible video colonoscope, reusableGastroenterologyClass B
206Flexible video colonoscope, single- useGastroenterologyClass B
207Flexible video duodenoscope, reusableGastroenterologyClass B
208Flexible video duodenoscope, single- useGastroenterologyClass B
209Flexible video enteroscopeGastroenterologyClass B
210Flexible video gastroduodenoscopeGastroenterologyClass B
211Flexible video gastroscopeGastroenterologyClass B
212Flexible video oesophagoscope, reusableGastroenterologyClass B
213Flexible video oesophagoscope, single-useGastroenterologyClass B
214Flexible video pancreatoscopeGastroenterologyClass B
215Flexible video sigmoidoscopeGastroenterologyClass B
216Gastric tonometry catheterGastroenterologyClass B
217Gastrointestinal catheter/endoscope tracking systemGastroenterologyClass B
218Gastrointestinal endoscopic clip applierGastroenterologyClass B
219Gastrointestinal endoscopic clip cutterGastroenterologyClass B
220Gastrointestinal endoscopic clip cutter generatorGastroenterologyClass B
221Gastrointestinal manometric catheter, electronicGastroenterologyClass B
222Gastrointestinal manometric catheter, non-electronicGastroenterologyClass B
223Gastrointestinal/airway foreign body retrieval basketGastroenterologyClass B
224Gastro-oesophageal pH/impedance catheter, non-sterileGastroenterologyClass B
225Gastro-oesophageal pH/impedance catheter, sterileGastroenterologyClass B
226Gastrostomy tube Y-piece connectorGastroenterologyClass B
227Gastro-urological directorGastroenterologyClass B
228Gastro-urological probeGastroenterologyClass B
229Gastro-urological scoopGastroenterologyClass B
230Intestinal stoma shield/support belt, reusableGastroenterologyClass B
231Intestinal stoma shield/support belt, single-useGastroenterologyClass B
232Intraluminal oesophageal retractorGastroenterologyClass B
233Invasive silicone sheet dressingGastroenterologyClass B
234Laparoscopic cholangiography catheter/needleGastroenterologyClass B
235Laparoscopic grasping forceps, reprocessedGastroenterologyClass B
236Laparoscopic grasping forceps, reusableGastroenterologyClass B
237Laparoscopic grasping forceps, single- useGastroenterologyClass B
238Laparoscopic swab forcepsGastroenterologyClass B
239Manual enema deviceGastroenterologyClass B
240Manual enema device, reusableGastroenterologyClass B
241Manual rectal irrigation systemGastroenterologyClass B
242Motorized laparoscopic forcepsGastroenterologyClass B
243Nasogastric decompression tubeGastroenterologyClass B
244Nasogastric tube holder, intranasalGastroenterologyClass B
245Oesophageal temperature monitorGastroenterologyClass B
246Over-guidewire oesophageal dilatorGastroenterologyClass B
247Percutaneous biliary biopsy procedure kitGastroenterologyClass B
248Powered rectal/colostomy irrigation systemGastroenterologyClass B
249Proctoscope, reusableGastroenterologyClass B
250Proctoscope, single-useGastroenterologyClass B
251Rectal irrigation kitGastroenterologyClass B
252Rectal speculumGastroenterologyClass B
253Rectal suction biopsy systemGastroenterologyClass B
254Rectoscope, reusableGastroenterologyClass B
255Rectoscope, single-useGastroenterologyClass B
256Rigid oesophagoscopeGastroenterologyClass B
257Rigid sigmoidoscopeGastroenterologyClass B
258Robotic surgical retractorGastroenterologyClass B
259Self-propelled flexible video colonoscopeGastroenterologyClass B
260Spring-loaded pneumoperitoneum needle, reusableGastroenterologyClass B
261Spring-loaded pneumoperitoneum needle, single-useGastroenterologyClass B
262Static magnetic anal plugGastroenterologyClass B
263Stoma drainage catheterGastroenterologyClass B
264TEM/TEO rectoscope, opticalGastroenterologyClass B
265TEM/TEO rectoscope, videoGastroenterologyClass B
266Video capsule endoscopy systemGastroenterologyClass B
267Video capsule endoscopy system application softwareGastroenterologyClass B
268Video capsule endoscopy system capsuleGastroenterologyClass B
269Biliary/urinary stone retrieval basket, reusableUrologyClass B
270Bladder-emptying vibratory stimulatorUrologyClass B
271CystometerUrologyClass B
272Cystometer probe, ultrasonicUrologyClass B
273Cystoscopic electrodeUrologyClass B
274Electrohydraulic lithotripsy systemUrologyClass B
275Electrohydraulic/pneuma tic lithotripsy system probe, urinary, single-useUrologyClass B
276Electromechanical lithotripsy system, intracorporealUrologyClass B
277Fibreoptic ureteral catheter, reusableUrologyClass B
278Filiform urethral bougieUrologyClass B
279Flexible endoscopic stone- retrieval forceps, reusableUrologyClass B
280Flexible fibreoptic cystonephroscopeUrologyClass B
281Flexible fibreoptic cystoscopeUrologyClass B
282Flexible fibreoptic cystourethroscopeUrologyClass B
283Flexible fibreoptic nephroscopeUrologyClass B
284Flexible fibreoptic ureterorenoscopeUrologyClass B
285Flexible fibreoptic ureteroscopeUrologyClass B
286Flexible fibreoptic urethroscopeUrologyClass B
287Flexible ureteral sheath/fibreoptic telescopeUrologyClass B
288Flexible video cystonephroscopeUrologyClass B
289Flexible video cystoscope, reusableUrologyClass B
290Flexible video cystourethroscopeUrologyClass B
291Flexible video nephroscopeUrologyClass B
292Flexible video ureterorenoscope, reusableUrologyClass B
293Flexible video ureteroscope, reusableUrologyClass B
294Flexible video urethroscopeUrologyClass B
295General-purpose ureteral catheterUrologyClass B
296Hand pneumatic lithotripsy system, urinaryUrologyClass B
297Hepatic function analysis systemUrologyClass B
298Incontinence sensor/alarmUrologyClass B
299Intermittent urethral catheterization kit, non- sterileUrologyClass B
300Intermittent urethral catheterization kit, sterileUrologyClass B
301Intermittent urethral drainage catheter, antimicrobialUrologyClass B
302Intermittent urethral drainage catheter, non- sterileUrologyClass B
303Intermittent urethral drainage catheter, sterileUrologyClass B
304Intracorporeal lithotripsy suction systemUrologyClass B
305Intraurethral valve/pumpUrologyClass B
306LithotriteUrologyClass B
307Male urinary outflow analysis systemUrologyClass B
308Male urinary outflow analysis system cuffUrologyClass B
309Manometric catheter sheathUrologyClass B
310Penile extracorporeal shock wave therapy systemUrologyClass B
311Penile extracorporeal shock wave therapy system applicatorUrologyClass B
312Penis wearable urinalUrologyClass B
313Penis/scrotum wearable urinalUrologyClass B
314PyeloscopeUrologyClass B
315Rigid cystoscopeUrologyClass B
316Rigid cystourethroscopeUrologyClass B
317Rigid nephroscopeUrologyClass B
318Rigid ureterorenoscopeUrologyClass B
319Rigid ureteroscopeUrologyClass B
320Rigid urethroscopeUrologyClass B
321Rigid video ureterorenoscopeUrologyClass B
322Spark-gap lithotripsy systemUrologyClass B
323Suprapubic needle, surgical, reusableUrologyClass B
324Temperature-monitoring indwelling urethral drainage catheterUrologyClass B
325Transobturator needle, reusableUrologyClass B
326Transvaginal needle, surgicalUrologyClass B
327Ultrasonic lithotripsy systemUrologyClass B
328Ureteral patency kitUrologyClass B
329Urethral drainage catheter punchUrologyClass B
330Urodynamic measurement systemUrologyClass B
331Liquid crystal forehead temperature stripGeneral HospitalClass B
332Electrically powered spinal fluid pressure monitorGeneral HospitalClass B
333Spinal fluid manometerGeneral HospitalClass B
334Sterilization process indicator (Biological)General HospitalClass B
335Sterilization process indicator (Physical/chemical)General HospitalClass B
336Clinical electronic thermometer.General HospitalClass B
337Clinical mercury thermometer.General HospitalClass B
338Pediatric medical crib.General HospitalClass B
339Medical bassinet.General HospitalClass B
340Pressure infusor for an I.V. bag.General HospitalClass B
341Intravascular administration set, automated air removal system.General HospitalClass B
342Patient care reverse isolation chamber.General HospitalClass B
343Patient lift, Electrcially poweredGeneral HospitalClass B
344Neonatal phototherapy unit.General HospitalClass B
345Ultrasonic cleaner for medical instruments.General HospitalClass B
346Sharps needle destruction device.General HospitalClass B
347Remote Medication Management System.General HospitalClass B
348Surgical Light, Single or Multi domeGeneral HospitalClass B
349Medical examination light, AC powered or BatteryGeneral HospitalClass B
350Medical ultraviolet air purifier.General HospitalClass B
351Vacuum-powered body fluid suction apparatus.General HospitalClass B
352Washers for body waste receptacles.General HospitalClass B
353Sterilization wrap.General HospitalClass B
354General purpose disinfectants.General HospitalClass B
355Medical washer.General HospitalClass B
356Blood VacutainerGeneral HospitalClass B
357Hemostatic clip applierOperation Theatre (OT)Class B
358Hemostatic knifeOperation Theatre (OT)Class B
359ScalpelOperation Theatre (OT)Class B
360Scalpel bladeOperation Theatre (OT)Class B
361Surgical forcepsOperation Theatre (OT)Class B
362Staple removerOperation Theatre (OT)Class B
363Surgical punchOperation Theatre (OT)Class B
364Surgical fileOperation Theatre (OT)Class B
365Blood vessel surgical stripperOperation Theatre (OT)Class B
366Surgical probeOperation Theatre (OT)Class B
367Powered general- purpose operation tableOperation Theatre (OT)Class B
368Operation table systemOperation Theatre (OT)Class B
369Activated-oxygen generatorRespiratoryClass B
370Aerosol inhalation monitorRespiratoryClass B
371Argon gas analyserRespiratoryClass B
372Artificial airway tube cuff pressure monitorRespiratoryClass B
373BronchoscopeRespiratoryClass B
374Cerebral oximeterRespiratoryClass B
375Chest-oscillation airway secretion- clearing systemRespiratoryClass B
376Chest-percussion airway secretion- clearing systemRespiratoryClass B
377Cold-air diagnostic inhalation systemRespiratoryClass B
378CricothyrotomeRespiratoryClass B
379Diagnostic spirometerRespiratoryClass B
380Electroacoustical airway secretion- clearing systemRespiratoryClass B
381Electronic oesophageal stethoscopeRespiratoryClass B
382Foetal pulse oximeterRespiratoryClass B
383Heated respiratory humidifierRespiratoryClass B
384Home-use sleep apnoea recording systemRespiratoryClass B
385Hypopnea sensor/alarmRespiratoryClass B
386Impedance pneumography recording/analysis systemRespiratoryClass B
387Infant apnoea monitorRespiratoryClass B
388Intracardiac oximeterRespiratoryClass B
389Intravascular oximeterRespiratoryClass B
390Invasive arterial pressure cardiac output/oximetry monitorRespiratoryClass B
391Manual chest percussorRespiratoryClass B
392Medical/surgical stringRespiratoryClass B
393Monitoring spirometerRespiratoryClass B
394Nitrogen monoxide analyserRespiratoryClass B
395Nitrous oxide analyserRespiratoryClass B
396Oxygen concentratorRespiratoryClass B
397Pneumatic chest percussorRespiratoryClass B
398Public respirator (2 ply, 3 ply face mask)RespiratoryClass B
399Pulmonary function analysis systemRespiratoryClass B
400Pulse oximetry telemetric monitoring systemRespiratoryClass B
401Respiration monitorRespiratoryClass B
402Respiratory apnoea monitoring systemRespiratoryClass B
403Thoracic bioconductance measurement systemRespiratoryClass B
404Thoracic electrical impedance segmentography systemRespiratoryClass B
405Thoracic suction pumpRespiratoryClass B
406Tongue-adjustment sleep apnoea treatment systemRespiratoryClass B
407Tracheostoma protectorRespiratoryClass B
408TracheotomeRespiratoryClass B
409Transcutaneous blood gas monitoring systemRespiratoryClass B
410Ultrasonic respiratory humidifierRespiratoryClass B
411Vacuum-assisted airway secretion- clearing systemRespiratoryClass B
412Whole-body plethysmographRespiratoryClass B
413Analgesic PENS systemNeurologicalClass B
414Analgesic TENS systemNeurologicalClass B
415Analytical scalp electrodeNeurologicalClass B
416Analytical scalp leadNeurologicalClass B
417Arthritis TENS systemNeurologicalClass B
418Cranial perforatorNeurologicalClass B
419Diagnostic somatosensory tactile stimulation systemNeurologicalClass B
420Electroencephalogram (EEG) signal spectrum analyzer.NeurologicalClass B
421Electroencephalograph electrode/lead tester.NeurologicalClass B
422Electroencephalograph test signal generator.NeurologicalClass B
423Electroencephalographic electrode capNeurologicalClass B
424Electroencephalographic long- term ambulatory recorderNeurologicalClass B
425Electroencephalographic simulatorNeurologicalClass B
426ElectromyographNeurologicalClass B
427ElectronystagmographNeurologicalClass B
428Facial nerve locating systemNeurologicalClass B
429Gait-enhancement electrical stimulation system, externalNeurologicalClass B
430GustometerNeurologicalClass B
431Interferential electrical stimulation systemNeurologicalClass B
432LeukotomeNeurologicalClass B
433Magnetoencephalography systemNeurologicalClass B
434Manual surgical saw, flexibleNeurologicalClass B
435Neuromuscular transmission motion sensorNeurologicalClass B
436Neurophysiologic monitoring systemNeurologicalClass B
437Neurosurgical head holder (skull clamp).NeurologicalClass B
438Neurosurgical microscopeNeurologicalClass B
439Neurosurgical ultrasound navigation systemNeurologicalClass B
440Otoacoustic emission systemNeurologicalClass B
441Physical therapy ultrasound/neuromuscular stimulation systemNeurologicalClass B
442Transcranial electrical stimulation system, continuous- current and pulsed-currentNeurologicalClass B
443Biosanitizer for Medical devicesPersonal UseClass B
444Nitrile glovesPersonal UseClass B
445Latex surgical glovePersonal UseClass B
446Non-latex surgical glovePersonal UseClass B
447chemotherapy spill clean-up kitPersonal UseClass B
448Medical/Cadaver Body BagsPersonal UseClass B
449Abortion suction system manual aspiratorObstetrical and Gynaecological (OG)Class B
450Cervical anaesthesia kitObstetrical and Gynaecological (OG)Class B
451Cervical anaesthesia needle, reusable or single useObstetrical and Gynaecological (OG)Class B
452ColposcopeObstetrical and Gynaecological (OG)Class B
453Endocervical aspiratorObstetrical and Gynaecological (OG)Class B
454Endocervical specimen collection kit, no additiveObstetrical and Gynaecological (OG)Class B
455Endometrial biopsy curetteObstetrical and Gynaecological (OG)Class B
456Endometrial biopsy kitObstetrical and Gynaecological (OG)Class B
457Endometrial cytology brushObstetrical and Gynaecological (OG)Class B
458Fallopian tube biopsy everting-balloon catheterObstetrical and Gynaecological (OG)Class B
459Fallopian tube catheterization kitObstetrical and Gynaecological (OG)Class B
460Fallopian tube insufflatorObstetrical and Gynaecological (OG)Class B
461Fixed-diameter cervical dilator, reusable or single useObstetrical and Gynaecological (OG)Class B
462Flexible fibreoptic culdoscopeObstetrical and Gynaecological (OG)Class B
463Flexible fibreoptic hysteroscopeObstetrical and Gynaecological (OG)Class B
464Flexible fibreoptic laparoscopeObstetrical and Gynaecological (OG)Class B
465Flexible fibreoptic mammary ductoscopeObstetrical and Gynaecological (OG)Class B
466Flexible fibreoptic salpingoscopeObstetrical and Gynaecological (OG)Class B
467Flexible ultrasound laparoscopeObstetrical and Gynaecological (OG)Class B
468Flexible video culdoscopeObstetrical and Gynaecological (OG)Class B
469Flexible video hysteroscopeObstetrical and Gynaecological (OG)Class B
470Flexible video laparoscopeObstetrical and Gynaecological (OG)Class B
471Flexible video mammary ductoscopeObstetrical and Gynaecological (OG)Class B
472Flexible video salpingoscopeObstetrical and Gynaecological (OG)Class B
473Foetal acoustic stimulatorObstetrical and Gynaecological (OG)Class B
474Foetal blood samplerObstetrical and Gynaecological (OG)Class B
475Foetal vacuum extraction cup, reusable or single useObstetrical and Gynaecological (OG)Class B
476Foetal vacuum extraction system monitorObstetrical and Gynaecological (OG)Class B
477Foetal vacuum extraction system, manual, reusable or single useObstetrical and Gynaecological (OG)Class B
478Foetal vacuum extraction system, pneumaticObstetrical and Gynaecological (OG)Class B
479Foetal/maternal multiple physiological parameter simulation kitObstetrical and Gynaecological (OG)Class B
480Foetal/maternal multiple physiological parameter simulatorObstetrical and Gynaecological (OG)Class B
481Gynaecological scissors, reusable or single useObstetrical and Gynaecological (OG)Class B
482Gynaecological surgical microscopeObstetrical and Gynaecological (OG)Class B
483Hysteroscopic insufflatorObstetrical and Gynaecological (OG)Class B
484Hysteroscopic irrigation/insufflation systemObstetrical and Gynaecological (OG)Class B
485Intrauterine cannula, reusable or single useObstetrical and Gynaecological (OG)Class B
486Intrauterine haemostatic balloon catheterObstetrical and Gynaecological (OG)Class B
487Intrauterine haemostatic suction catheterObstetrical and Gynaecological (OG)Class B
488Intrauterine imaging medium catheterObstetrical and Gynaecological (OG)Class B
489Intrauterine imaging medium catheterization kitObstetrical and Gynaecological (OG)Class B
490Laparoscope laser coupler or laser/laparoscope adaptorObstetrical and Gynaecological (OG)Class B
491Laparoscope system, reprocessedObstetrical and Gynaecological (OG)Class B
492Laparoscope system, reusable or single useObstetrical and Gynaecological (OG)Class B
493Manual expandable cervical dilatorObstetrical and Gynaecological (OG)Class B
494Mechanical foetal heart simulatorObstetrical and Gynaecological (OG)Class B
495Menstrual cup, Hevea-latexObstetrical and Gynaecological (OG)Class B
496Menstrual cup, non-latex, reusable or single useObstetrical and Gynaecological (OG)Class B
497Menstrual tampon, scented or unscentedObstetrical and Gynaecological (OG)Class B
498Motorized laparoscopic forcepsObstetrical and Gynaecological (OG)Class B
499Papanicolaou smear kit or Endometrial sampling kitObstetrical and Gynaecological (OG)Class B
500Pelvic examination kitObstetrical and Gynaecological (OG)Class B
501PelvimeterObstetrical and Gynaecological (OG)Class B
502PelviscopeObstetrical and Gynaecological (OG)Class B
503Perineal warmerObstetrical and Gynaecological (OG)Class B
504PerineometerObstetrical and Gynaecological (OG)Class B
505Pudendal anaesthesia kitObstetrical and Gynaecological (OG)Class B
506ResectoscopeObstetrical and Gynaecological (OG)Class B
507Rigid culdoscopeObstetrical and Gynaecological (OG)Class B
508Rigid fibreoptic hysteroscopeObstetrical and Gynaecological (OG)Class B
509Rigid mammary ductoscopeObstetrical and Gynaecological (OG)Class B
510Rigid optical laparoscopeObstetrical and Gynaecological (OG)Class B
511Rigid salpingoscopeObstetrical and Gynaecological (OG)Class B
512Rigid ultrasound laparoscopeObstetrical and Gynaecological (OG)Class B
513Rigid video hysteroscopeObstetrical and Gynaecological (OG)Class B
514Rigid video laparoscopeObstetrical and Gynaecological (OG)Class B
515Suprapubic needle, surgical, reusable or single useObstetrical and Gynaecological (OG)Class B
516Uterine injectorObstetrical and Gynaecological (OG)Class B
517Uterine manipulator cervical cup/transilluminatorObstetrical and Gynaecological (OG)Class B
518Uterine manipulator, reusable or single useObstetrical and Gynaecological (OG)Class B
519Uterine packerObstetrical and Gynaecological (OG)Class B
520Uterine probeObstetrical and Gynaecological (OG)Class B
521Uterus-supporting pessaryObstetrical and Gynaecological (OG)Class B
522Vaginal dilatorObstetrical and Gynaecological (OG)Class B
523Vaginal douche, reusable or single useObstetrical and Gynaecological (OG)Class B
524Vaginal douching fluid tabletObstetrical and Gynaecological (OG)Class B
525VaginoscopeObstetrical and Gynaecological (OG)Class B
526Viscera retention paddle or Visceral retainerObstetrical and Gynaecological (OG)Class B
527Amniotome, reusableObstetrical and Gynaecological (OG)Class B
528Bladder-supporting pessaryObstetrical and Gynaecological (OG)Class B
529Catheter-tip transducer, pressureObstetrical and Gynaecological (OG)Class B
530Foetal Doppler systemObstetrical and Gynaecological (OG)Class B
531Foetal Doppler system probeObstetrical and Gynaecological (OG)Class B
532Menstrual pad, scentedObstetrical and Gynaecological (OG)Class B
533AdaptometerOphthalmicClass B
534Contact LensOphthalmicClass B
535Corneal burr manual instrumentOphthalmicClass B
536Corneal burr systemOphthalmicClass B
537Corneal burr, abrasionOphthalmicClass B
538Corneal burr, rust ring removalOphthalmicClass B
539Corneal epithelium perforatorOphthalmicClass B
540Corneal epithelium trephineOphthalmicClass B
541Corneal light shieldOphthalmicClass B
542Corneal markerOphthalmicClass B
543Corneal resection holderOphthalmicClass B
544Corneal scissorsOphthalmicClass B
545Corneal shieldOphthalmicClass B
546Corneoscleral punchOphthalmicClass B
547Epiretinal/inner limiting membrane scraperOphthalmicClass B
548EuthyscopeOphthalmicClass B
549Eye cupOphthalmicClass B
550Eye heat therapy packOphthalmicClass B
551Eye muscle clampOphthalmicClass B
552Flieringa ophthalmic ringOphthalmicClass B
553KeratomeOphthalmicClass B
554Lacrimal tubeOphthalmicClass B
555Ophthalmic operating table topOphthalmicClass B
556Ophthalmic soft-tissue surgical forcepsOphthalmicClass B
557Ophthalmic tonometerOphthalmicClass B
558Ophthalmic ultrasound imaging systemOphthalmicClass B
559Scleral markerOphthalmicClass B
560Ultrasound pachymeterOphthalmicClass B
561Bone sonometerInterventional and RadiologyClass B
562Radionuclide dose calibratorInterventional and RadiologyClass B
563Nonfetal ultrasonic monitorInterventional and RadiologyClass B
564Ultrasonic pulsed doppler imaging systemInterventional and RadiologyClass B
565Ultrasonic pulsed echo imaging systemInterventional and RadiologyClass B
566Diagnostic ultrasonic transducerInterventional and RadiologyClass B
567Diagnostic x-ray high voltage generatorInterventional and RadiologyClass B
568Pneumoencephalo graphic chairInterventional and RadiologyClass B
569Radiographic film cassetteInterventional and RadiologyClass B
570Radiographic film/cassette changerInterventional and RadiologyClass B
571Flexible ultrasound colonoscopeInterventional and RadiologyClass B
572Flexible ultrasound duodenoscopeInterventional and RadiologyClass B
573Flexible ultrasound gastroduodenosco peInterventional and RadiologyClass B
574Flexible ultrasound laparoscopeInterventional and RadiologyClass B
575Flexible ultrasound bronchoscopeInterventional and RadiologyClass B
576Bladder ultrasound imaging transducerInterventional and RadiologyClass B
577General-purpose ultrasound imaging systemInterventional and RadiologyClass B
578Organ bag.Dermatology and Plastic SurgeryClass B
579Low energy ultrasound wound cleanerDermatology and Plastic SurgeryClass B
580Surgical drape and drape accessoriesDermatology and Plastic SurgeryClass B
581Suture retention deviceDermatology and Plastic SurgeryClass B
582Wound autofluorescence imaging deviceDermatology and Plastic SurgeryClass B
583Battery-powered trephine systemDermatology and Plastic SurgeryClass B
584Colonoscope, General & Plastic SurgeryDermatology and Plastic SurgeryClass B
585Cryosurgical unit and accessoriesDermatology and Plastic SurgeryClass B
586Dermal dilatorDermatology and Plastic SurgeryClass B
587Electrically- powered trephine systemDermatology and Plastic SurgeryClass B
588Electrosurgical device for over-the- counter aesthetic useDermatology and Plastic SurgeryClass B
589Esophagoscope, General & Plastic SurgeryDermatology and Plastic SurgeryClass B
590Gas-powered dermatomeDermatology and Plastic SurgeryClass B
591Gas-powered surgical sawDermatology and Plastic SurgeryClass B
592Gas-powered trephine systemDermatology and Plastic SurgeryClass B
593Hemostatic knifeDermatology and Plastic SurgeryClass B
594Irrigating wound retractor device.Dermatology and Plastic SurgeryClass B
595Liposuction catheterDermatology and Plastic SurgeryClass B
596Powered corneal trephineDermatology and Plastic SurgeryClass B
597Powered dermatomeDermatology and Plastic SurgeryClass B
598Powered suction pump.Dermatology and Plastic SurgeryClass B
599Removable skin clipDermatology and Plastic SurgeryClass B
600Removable skin stapleDermatology and Plastic SurgeryClass B
601Single-use dermatome bladeDermatology and Plastic SurgeryClass B
602Skin StaplerDermatology and Plastic SurgeryClass B
603Soft tissue trephineDermatology and Plastic SurgeryClass B
604Aerosol tent, paediatricPediatrics and NeonatologyClass B
605Airway Pressure / Oxygen MonitorPediatrics and NeonatologyClass B
606Anaesthesia Facemask, single use (paediatric)Pediatrics and NeonatologyClass B
607Anaesthesia Facemask, reusable (paediatric)Pediatrics and NeonatologyClass B
608Circulating-air whole-body heating/cooling system pad, reusablePediatrics and NeonatologyClass B
609Circulating-air whole-body heating/cooling system pad, single- use, sterilePediatrics and NeonatologyClass B
610Circulating-fluid whole-body heating/cooling system pad, reusablePediatrics and NeonatologyClass B
611Circulating-fluid whole-body heating/cooling system pad, single- usePediatrics and NeonatologyClass B
612Closed-ended adhesive infant/paediatric urine collection bagPediatrics and NeonatologyClass B
613Electric pad whole-body heating systemPediatrics and NeonatologyClass B
614Electric pad whole-body heating system padPediatrics and NeonatologyClass B
615External counterpulsation system, paediatricPediatrics and NeonatologyClass B
616External defibrillator electrode, paediatric, reusablePediatrics and NeonatologyClass B
617External defibrillator electrode, paediatric, single-usePediatrics and NeonatologyClass B
618Hepatic ultrasound elastography system applicatorPediatrics and NeonatologyClass B
619Infant bed crib topPediatrics and NeonatologyClass B
620Infant bed restraintPediatrics and NeonatologyClass B
621Infant heat shieldPediatrics and NeonatologyClass B
622Infant resuscitation cabinetPediatrics and NeonatologyClass B
623Infant resuscitation tablePediatrics and NeonatologyClass B
624Liquid crystal vein locatorPediatrics and NeonatologyClass B
625Neonatal chest percussorPediatrics and NeonatologyClass B
626Neonatal electrocardiographic electrodePediatrics and NeonatologyClass B
627Neonatal hypothermia cotPediatrics and NeonatologyClass B
628Neonatal hypothermia cot heat- conduction mattressPediatrics and NeonatologyClass B
629Neonatal hypothermia cot heat- retention padPediatrics and NeonatologyClass B
630Neonatal pulmonary surfactant catheterPediatrics and NeonatologyClass B
631Non-rechargeable public semi- automated external defibrillator electrode, paediatricPediatrics and NeonatologyClass B
632Open-ended adhesive infant/paediatric urine collection bagPediatrics and NeonatologyClass B
633Ophthalmic tonometer, battery- operatedPediatrics and NeonatologyClass B
634Orthopaedic medialization instrumentPediatrics and NeonatologyClass B
635Oxygen administration tent, neonatal/paediatricPediatrics and NeonatologyClass B
636Paediatric bedPediatrics and NeonatologyClass B
637Paediatric blood donor setPediatrics and NeonatologyClass B
638Paediatric dental chair, electricPediatrics and NeonatologyClass B
639Paediatric dental chair, mechanicalPediatrics and NeonatologyClass B
640Paediatric strabismus screening scannerPediatrics and NeonatologyClass B
641Paediatric-temperature nasogastric/orogastric tubePediatrics and NeonatologyClass B
642Blanket/pad infant phototherapy unitPediatrics and NeonatologyClass B
643Flotation therapy bed, neonatalPediatrics and NeonatologyClass B
644Otoacoustic emission system, battery-poweredPediatrics and NeonatologyClass B
645Otoacoustic emission system, line- poweredPediatrics and NeonatologyClass B
646Overhead infant phototherapy unitPediatrics and NeonatologyClass B
647Thoracic electrical impedance segmentography systemPediatrics and NeonatologyClass B
648Thoracic electrical impedance segmentography system electrode arrayPediatrics and NeonatologyClass B
649Wearable neonatal heart rate meterPediatrics and NeonatologyClass B
650Antimicrobial infant garmentPediatrics and NeonatologyClass B
651Boiling water sterilizerPediatrics and NeonatologyClass B
652Resuscitator face mask, reusablePediatrics and NeonatologyClass B
653Resuscitator face mask, single-usePediatrics and NeonatologyClass B
654Warming infant bed, adjustablePediatrics and NeonatologyClass B
655Warming infant bed, non-adjustablePediatrics and NeonatologyClass B
656Blanket/pad infant phototherapy unit testerPediatrics and NeonatologyClass B
657Blood transfusion set, exchangePediatrics and NeonatologyClass B
658Blue light radiometerPediatrics and NeonatologyClass B
659Cranial orthosisPediatrics and NeonatologyClass B
660Multi-purpose saline solutionPediatrics and NeonatologyClass B
661Open infant incubatorPediatrics and NeonatologyClass B
662Pulmonary function analysis system, paediatricPediatrics and NeonatologyClass B
663Reactive-gel heating padPediatrics and NeonatologyClass B
664Rocking infant bed, electricPediatrics and NeonatologyClass B
665Teething device, fluid-filledPediatrics and NeonatologyClass B
666Visual-reinforcement-audiometry reward systemPediatrics and NeonatologyClass B
667Bladder instillation buffer solutionOncologyClass B
668Colonic cytology sampling setOncologyClass B
669ColposcopeOncologyClass B
670Acupressure wristbandOncologyClass B
671Bladder brachytherapy system applicator, manualOncologyClass B
672Brachytherapy system chairOncologyClass B
673Brachytherapy system remote afterloading source transfer tubeOncologyClass B
674Cervical cytology scraper, single- useOncologyClass B
675Cervical/intrauterine brachytherapy system applicator, manualOncologyClass B
676Class-I biological safety cabinetOncologyClass B
677Elastomeric infusion pump systemOncologyClass B
678Externally-propelled flexible video colonoscopeOncologyClass B
679Facial prosthesisOncologyClass B
680Flexible fibreoptic bronchoscopeOncologyClass B
681Flexible fibreoptic colonoscopeOncologyClass B
682Flexible fibreoptic duodenoscopeOncologyClass B
683Flexible fibreoptic gastroscopeOncologyClass B
684Flexible fibreoptic sigmoidoscopeOncologyClass B
685Flexible video bronchoscope, reusableOncologyClass B
686Flexible video colonoscope, reusableOncologyClass B
687Brachytherapy system chairRadiotherapyClass B
688Compact thermoluminescent dosimetry electrometerRadiotherapyClass B
689Intra-vaginal organ positioning device for diagnostic imaging and radiotherapyRadiotherapyClass B
690Laser irradiation therapy kitRadiotherapyClass B
691Light beam patient position indicatorRadiotherapyClass B
692Manual radionuclide applicator systemRadiotherapyClass B
693Non-powered accelerator system tableRadiotherapyClass B
694Non-powered neutron therapy tableRadiotherapyClass B
695Radionuclide brachytherapy tableRadiotherapyClass B
696Non-powered remote irradiation therapy tableRadiotherapyClass B
697Non-powered X-rays radiation therapy tableRadiotherapyClass B
698Operator radiation protection spectaclesRadiotherapyClass B
699Patient positioning device for pelvis diagnostic imaging and radiotherapyRadiotherapyClass B
700Patient positioning device for whole body diagnostic imaging and radiotherapyRadiotherapyClass B
701Powered neutron therapy tableRadiotherapyClass B
702Powered patient table for acceleratorRadiotherapyClass B
703Powered radionuclide brachytherapy tableRadiotherapyClass B
704Powered remote irradiation therapy tableRadiotherapyClass B
705Powered X-rays radiation therapy tableRadiotherapyClass B
706Radiographic Protective GloveRadiotherapyClass B
707Radionuclide dynamic function testing equipmentRadiotherapyClass B
708Stationary radiation protection barrierRadiotherapyClass B
709Urinary stone retrieval basketNephrology and Renal CareClass B
710Dialyser connectorNephrology and Renal CareClass B
711Flexible fibreoptic nephroscopeNephrology and Renal CareClass B
712Hemodialysis blood tubing/Extracorporeal systems for blood purificationNephrology and Renal CareClass B
713Laser lithotripsy fibre/suction guideNephrology and Renal CareClass B
714Peritoneal dialysis catheter guidewireNephrology and Renal CareClass B
715Peritoneal dialysis ultraviolet irradiation unitNephrology and Renal CareClass B
716Rigid nephroscopeNephrology and Renal CareClass B
717Shunt thrombus suction setNephrology and Renal CareClass B
718Portable continuous peritoneal perfusate thermal conditonerNephrology and Renal CareClass B
719Citric acid haemodialysis system cleaning cartridgeNephrology and Renal CareClass B
720Extracorporeal circuit waste bagNephrology and Renal CareClass B
721Haemodialysis dialysate water chlorine test kit/stripNephrology and Renal CareClass B
722Continuous Glucose Monitor Secondary DisplaySoftwareClass B
723Insulin Pump Secondary DisplaySoftwareClass B
724Multivariate Vital Signs IndexSoftwareClass B
725Electrocardiograph Software for home use.SoftwareClass B
726Photoplethysmogra ph Analysis Software for home use.SoftwareClass B
727Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune DiseaseSoftwareClass B
728Ataxiagraph With Interpretive SoftwareSoftwareClass B
729Colon Computed Tomography System, Computer Aided DetectionSoftwareClass B
730Lung Computed Tomography System, Computer- Aided DetectionSoftwareClass B
731Chest X-Ray Computer Aided DetectionSoftwareClass B
732Radiological Computer Assisted Detection/Diagnosis Software For FractureSoftwareClass B
733X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software DeviceSoftwareClass B
734Automated Radiological Image Processing SoftwareSoftwareClass B
735Image Acquisition And/Or Optimization Guided By Artificial IntelligenceSoftwareClass B
736Chairside dental CAD/CAM unitSoftwareClass B
737Software for using with mammography- combined diagnostic X-ray systemSoftwareClass B
738Software for public thoracic and abdominal health screening diagnostic X-ray systemSoftwareClass B
739Software for visual evoked response stimulatorSoftwareClass B
740Software for auditory evoked response stimulatorSoftwareClass B
741Software for pulmonary exercise stress monitoring systemSoftwareClass B
742Software for ECG recorder with real- time analysisSoftwareClass B
743Software for film- recorded digital radiographySoftwareClass B
744Software for dye dilution cardiac output calculatorSoftwareClass B
745Software for urodynamic measurement systemSoftwareClass B
746Software for vestibular function caloric stimulatorSoftwareClass B
747Surporting software for external fixators treatment planSoftwareClass B
748Diagnostic supporting software for diabetesSoftwareClass B
749Quantitative calculation software for IGC testSoftwareClass B
750Analyzing software for hemodynamics or cardiac functionSoftwareClass B
751Supporting software for root canal treatmentSoftwareClass B

Class B Medical Devices by Speciality Category

Here is a quick-reference breakdown of all 751 Class B devices organized by medical speciality category:

Medical Speciality CategoryNo. of Class B Devices
Gastroenterology109
Obstetrical and Gynaecological (OG)84
Pediatrics and Neonatology63
Urology62
Dental60
Anesthesiology47
Respiratory44
Pain Management35
Neurological30
Software30
Ophthalmic28
General Hospital26
Dermatology and Plastic Surgery26
Radiotherapy22
Oncology20
Cardiovascular17
Interventional and Radiology17
Nephrology and Renal Care13
Operation Theatre (OT)12
Personal Use6

Documents Required for CDSCO Class B 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)

DocumentRequirement / Notes
Application Form MD-3 (Form 27D)Duly filled online application for manufacturing license on the CDSCO Sugam portal
Proof of Business RegistrationCertificate 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 CertificateDeclaration or third-party audit confirming GMP compliance for medical devices
ISO 13485 Quality Management System CertificatePreferred; some states/devices may require it as mandatory
Device Technical DocumentationDevice description, intended use, specifications, design summary, risk assessment (ISO 14971)
Performance/Safety Test ReportsLab reports from accredited lab confirming device meets applicable safety standards (IS/IEC/ISO)
List of Devices Proposed to Be ManufacturedSpecific device names as listed in the official CDSCO Class B classification
Details of Technically Qualified PersonnelQualifications and experience of key technical staff involved in manufacturing
Manufacturing Process Flow ChartStep-by-step manufacturing process for each device type
Declaration of ConformitySigned declaration that the device meets applicable safety and performance standards
Power of Attorney / Authorization LetterIf a consultant or authorized person is filing on behalf of the company

Additional Documents for Importers (Import License)

DocumentRequirement / 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 CertificateRegulatory approval in country of origin from a recognized regulatory authority
Indian Authorized Agent (IAA) AgreementSigned agreement between foreign manufacturer and registered Indian agent
IAA Registration CertificateCurrent CDSCO registration of the Indian Authorized Agent
Foreign Manufacturer's GMP CertificateISO 13485 or equivalent GMP certificate from accredited certification body
Product Labeling in EnglishLabel compliant with MDR 2017 Schedule III requirements
Device Technical Documentation (Summary)Design description, intended use, classification rationale, basic safety/performance summary
Performance Test ReportsTest reports from NABL-accredited or equivalent foreign labs (ILAC-MRA signatories accepted)
Undertaking from Foreign ManufacturerSigned undertaking confirming responsibility for product quality and compliance
Documents required for CDSCO Class B Medical device

Step-by-Step Process: How to Get a CDSCO Class B 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 B 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 Portal 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)
Process For Class B Medical Device License
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 B medical device licensing are set under the Second Schedule of MDR 2017. Here is the current fee structure:

License Type / ApplicantFee (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 PenaltyAdditional 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 B 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:

AspectDetails
License Validity PeriodManufacturing License: Valid for 3 years from date of issue. Import License: Valid for 3 years from date of issue.
Renewal Application DeadlineApply 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 ProcessFile renewal application via Sugam portal. Submit updated documents if any changes have occurred. Manufacturing facilities may require re-inspection.
Consequence of Expiry Without RenewalSelling 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 / ScopeAdding new devices to an existing license requires an amendment application and additional fees.
Change in Manufacturing AddressRequires a fresh inspection and amendment to the license. Cannot be done retrospectively.
Change in Company Name / OwnershipMust be disclosed to CDSCO within 30 days. Amendment application required.
Voluntary Surrender of LicenseIf you stop manufacturing/importing, file a voluntary surrender to avoid compliance obligations.

Key Benefits of Getting a CDSCO Class B License

A valid CDSCO Class B 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 AspectClass A (Non-Sterile, Non-Measuring) vs Class B
Registration vs LicenseClass A: Registration only (Chapter IIIB) | Class B: Full license required (Chapter IV)
Facility InspectionClass A: Not required | Class B: Mandatory for manufacturing license
ISO 13485 RequirementClass A: Optional but recommended | Class B: Expected, often mandatory
Technical DocumentationClass A: Basic device description | Class B: Full technical file including risk management and test reports
Clinical EvidenceClass A: Not required | Class B: May be required for specific device types
FeesClass A: ₹1,000–₹5,000 per device | Class B: ₹2,500–₹10,000 per device
Processing TimeClass A: 30–45 working days | Class B: 90–180 days (including inspection)
ValidityClass A: 5 years | Class B: 3 years
Post-Market ObligationsClass A: Minimal | Class B: Periodic safety reporting, vigilance system required

Conclusion — Get Your Class B License Right the First Time

CDSCO registration for Class B 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 751 Class B 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 B medical device in India under CDSCO?

A Class B medical device under MDR 2017 is a low-to-moderate 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 B 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 B 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 B 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

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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