Indian medical device regulations continue to evolve - albeit very slowly.
The country's health ministry aims to amend the Drugs and Cosmetics Act to provide separate definition and regulation of medical devices. Pharmabiz quoted sources as saying that "[t]he salient features of the proposed bill would be to provide a separate definition of Medical Devices, their risk based classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions".
The health ministry plans to increase staff and infrastructure at the Central Drugs Standard Control Organization's medical device division to support this expansion of the government's regulatory scope.
But the legislation hasn't yet been submitted to Parliament. Apparently, regional and special interests put the bill on the hold. Stay tuned...
[Hat tip to Emergo Group]
For more on India, take a look at the following:
- The Continuing Evolution of Clinical Research in India
- Indian Rupee symbol ripping off Roger Federer?
- Languages in India - a detailed look
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