India Will Require All Lower-Risk Class A Devices to be Registered Online

By this past October, device manufacturers and importers of Class A medical devices 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.