India DCGI Extends Device Registration

As noted in our July newsletter, the Indian authorities required all non-notified Class C and D devices to be registered by October 1. Such devices could include certain X-ray products, ventilators, etc. that have moderate to high risks. However, some medical device manufacturers claimed that they had applied for such licenses but had still not been audited yet. Thus, device manufacturers and importers of Class C and Class D products that have already submitted applications to the CDSCO, but have not been approved, will be able to continue their business for another 6 months, or until the CDSCO makes a determination on their application, depending on which occurs first. This is not the first Indian medical device registration to be postponed until a proper registration review can be done.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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