Medical Device Registration
The Indian medical regulatory system has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered.
With the rising opportunities in India comes increasing regulations that companies must face and overcome. With the assistance of a highly experienced third-party regulatory compliance consultant such as Pacific Bridge Medical, the registration process is much less complex. We can help you prepare and submit the required documents and materials to the relevant regulatory agencies in India.
Click on the questions below to find out more details on the registration and approval of medical devices in India.
WHICH REGULATORY BODIES IN THE INDIAN GOVERNMENT ARE RESPONSIBLE FOR MEDICAL DEVICE REGISTRATION IN INDIA?
- The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
- The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs.
- In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).