1st October 2022 marks a new beginning for Indian medical device regulations as India will start regulating all the medical devices that meet the medical device definition instead of confining to a few selected categories. This real #watershed_movement in Indian medical device regulations came on 11th February, 2020 with a dual notification from #CDSCO.
- O. 648(E). – The introduction of definition of medical device (Harmonised with global regulations) (https://bit.ly/3tTjGJj)
- S.R. 102(E). – The introduction of Medical Devices (Amendment) Rules, 2020 (#MDAR2020). (Regulating all the devices that meet the definition of medical device) (https://bit.ly/2Z4GN8x)
The #MDAR2020 has really opened up the Indian medical device regulations and extended the regulatory purview of medical devices from approximately 25% of devices (then) to virtually 100% devices (now). Before this amendment, only selected, mechanical and body fluid contacting devices were regulated leaving out majority of other medical devices.
The #MDAR2020 has introduced a phase-wise timeline to bring all the medical devices under regulations spanning from 30 – 42 months. The transition timeline for Class A & Class B medical devices has ended by 30th September 2022. From today all Class A & Class B the medical devices will come under the licensing process.
PS: The transition timeline for Class C & Class D medical devices will end by 30th September 2023.
• Import license process in India (https://bit.ly/2W3DjBD),
Let me know if you need any assistance.
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Sravan Kumar Manchikanti, RAC
Hyderabad
India
WhatsApp/iMessage: +91-9390029538
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