Do you know ๐๐๐ ๐๐๐ ๐๐๐
๐๐๐๐ ๐
๐๐๐๐๐ ๐๐๐๐๐๐๐๐๐๐๐ ๐๐๐๐ ๐๐ ๐๐ ๐๐๐๐๐๐๐๐๐? The story of medical device regulations across the globe is always a ๐๐๐๐๐-๐๐๐
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๐๐๐๐๐.โค In #USA โ ๐๐ฎ๐น๐ธ๐ผ๐ป ๐ฆ๐ต๐ถ๐ฒ๐น๐ฑ ๐๐จ๐ ๐ถ๐ป๐ฐ๐ถ๐ฑ๐ฒ๐ป๐ and subsequent incidents related to pacemakers and IOL infections have triggered the #US_FDA Medical Device Amendments, 1976 (https://bit.ly/3C2nX05)โค In #Europe โ ๐ฃ๐๐ฃ ๐๐ฟ๐ฒ๐ฎ๐๐ ๐๐ฐ๐ฎ๐บ was the triggering point for onset of #EU_MDR (https://bit.ly/38T93Na)#India too started its medical device regulations in the same note. The ๐๐ ๐ต๐ผ๐๐ฝ๐ถ๐๐ฎ๐น ๐ถ๐ป๐ฐ๐ถ๐ฑ๐ฒ๐ป๐ and subsequent push from 'Mumbai High Court' led to the introduction of medical device regulations in India in 2006 which were carved out from Drugs & Cosmetics Act (https://bit.ly/3AjH5Gl).From that point onwards, India has steadily strengthened its medical device regulations and it culminated with the introduction of ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ถ๐ฐ๐ฒ ๐ฅ๐๐น๐ฒ๐, ๐ฎ๐ฌ๐ญ๐ณ. The glimpse of the same is explained in our previous post (https://bit.ly/3BY0g8W) However, the real #watershed_movement in Indian medical device regulations came on 11th February, 2020 with a dual notification from #CDSCO.1. ๐ฆ.๐ข. ๐ฒ๐ฐ๐ด(๐). โ The introduction of definition of medical device (Harmonized with global regulations) (https://bit.ly/3tTjGJj)2. ๐.๐ฆ.๐ฅ. ๐ญ๐ฌ๐ฎ(๐). โ 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 ๐๐๐๐๐๐๐๐๐๐๐๐๐ 25% ๐๐ ๐
๐๐๐๐๐๐ (then) to ๐๐๐๐๐๐๐๐๐ 100% ๐
๐๐๐๐๐๐ (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 ๐ฏ๐ฌ โ ๐ฐ๐ฎ ๐บ๐ผ๐ป๐๐ต๐. Till that time, all the medical device manufacturers shall have to comply with nominal registration process set-out by CDSCO through its #online_portal. Keep following this page for more details on transition timelines.Here is the snapshot of differences between 'now' and 'then' with the introduction of these amendments. You can also have a look at our series of posts on medical devices------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
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