Medical Translation Insight

India is a large country with a fast-growing demand for high-quality medical technology products. However, regulation of medical devices has been slow in coming.

The year 2006 marked a turning point, of sorts. New guidelines for sterile medical devices came into force on March 1, 2006. Later in the year the draft Medical Device Regulation Act [PDF link] was released.

So, progress looks like it is coming - but it has been coming slowly.

A recent presentation of the Asian Harmonization Working Party [PDF link] outlined some of the past issues with the Indian regulatory system:

• medical devices are grouped with and regulated like drugs
• that, in turn, is posing difficulties in terms of manufacturing, testing, and adverse reporting
• to date, regulations have retroactive instead of proactive

Yet there could be an end to the delays: Pacific Bridge Medical reported a few weeks ago that India's Drug Consultative Committee and the Drug Technical Advisory Board approved the draft regulation and that final notification by the Ministry of Health "is expected soon".

When it's finally done, foreign as well as domestic device manufacturers will be relieved that they finally have a regulatory framework that allows them to continue growing their businesses.


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