Gunjan Verma- India

“Medical device manufacturers should act quickly to advise to CDSCO of any classification discrepancies.”
Gunjan Verma
Asia Actual India 

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India Seeks Input on Medical Device Classification

Published September 15, 2020

All formerly unregulated medical devices are now being transitioned to require registration in India under the Medical Device Rules, 2017.  These products should be Registered prior to October 1, 2021 and then obtain an Import License before October 1, 2022, or October 1, 2023 depending on the product’s risk classification.

In preparation for the new process, the Central Drugs Standard Control Organization (CDSCO) published a list of devices organized into 24 categories with proposed risk classification. A copy of the document is available here.

Manufacturers should review the proposed classification for their devices and work with their India Agent to provide feedback to the CDSCO on any perceived discrepancies in device classification with a deadline of October 2, 2020.

The CDSCO has released a list of 24 product categories for the public’s consideration prior to official implementation. It is encouraged that manufacturers review product categories and types relevant to their product line(s) and work with their Indian Agent to submit any comments prior to October 2, 2020.

The 24 Proposed Product Categories (Currently Voluntary):

No.CategoriesNumber of Device Types
1Anesthesiology115
2Pain Management69
3Cardiovascular37
4Dental89
5Ear, Nose, Throat (ENT)78
6Gastroenterological163
7Urological90
8General Hospital72
9Operation Theater (OT)27
10Respiratory71
11Neurological131
12Personal Use24
13Obstetric and Gynecological (OG)116
14Opthalmic144
15Rehabilitation48
16Physical Support38
17Interventional and Radiology71
18Rheumatology11
19Dermatology and Plastic Surgery56
20Pediatric and Neonatal Medical137
21Oncology78
22Radiotherapy102
23Nephrology and Renal Care39
24Software60

Please contact Asia Actual with any questions or requests for support.