The Indian health ministry has announced that all medical devices must meet specific safety and quality standards before they are introduced in the Indian market beginning April 1st, 2020.
This includes any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used specifically for human or animals. Devices used for one or more of the following purposes:
- (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
- (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- (iii) investigation, replacement, modification or support of the anatomy or of a physiological process;
- (iv) supporting or sustaining life;
- (v) disinfection of medical devices;
- (vi) control of conception.
Manufacturers and importers of medical devices will need to be registered with the Central Drugs Standard Control Organization (CDSCO) of India. For a period of eighteen months after April 1st, 2020, device manufacturers and importers can voluntarily register with CDSCO. The manufacturer or importer have to upload the information related to the medical device for registration on the “Online System for Medical Devices” established by CDSCO.
If you need more information on or assistance in obtaining India CDSCO certification, please contact G&M Compliance, Inc. at 714-628-1020