By this past October, device manufacturers and importers of Class A medical devices in India are required to register their products via an online portal. The manufacturer or importer will also need to confirm that their device meets the requirements of the essential principles checklist and is non-sterile and non-measuring. Information on the Class A device to be uploaded onto the online system includes the generic name, brand name, intended use, shelf life, etc. After self-certifying with the online system, a registration number will be issued. In addition, the manufacturer or importer will need to keep good records of the manufacture, import, sales, and distribution of such products or risk suspension or cancelation of their registration number.
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.