CDSCO Published Draft version of Medical Devices Guidance Documents

bio_subbu

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#1
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M

momara

#2
Dear Mr. Subramaniam,
we would like to sell and therefore register our medical products in India. As I heard, a CE mark and FDA approval is sufficient. In this draft paper much more documents are required. When will this draft document become final? What documents are required at the moment for the approval of medical devices in India?

Kind regards,
K. Budwitz
 

bio_subbu

Super Moderator
#3
Dear Mr. Subramaniam,
we would like to sell and therefore register our medical products in India. As I heard, a CE mark and FDA approval is sufficient. In this draft paper much more documents are required. When will this draft document become final? What documents are required at the moment for the approval of medical devices in India?

Kind regards,
K. Budwitz
The Drugs Controller General of India (DCGI) is getting responses/feedback from the manufacturers with regard to the comments on aforesaid guidance documents. But I don’t when will this draft version become final.
 
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