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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.||Categories||Number of Device Types|
|5||Ear, Nose, Throat (ENT)||78|
|9||Operation Theater (OT)||27|
|13||Obstetric and Gynecological (OG)||116|
|17||Interventional and Radiology||71|
|19||Dermatology and Plastic Surgery||56|
|20||Pediatric and Neonatal Medical||137|
|23||Nephrology and Renal Care||39|
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