CDSCO Medical Device Import License

Medical device importation in India is vital for every Manufacturer. To import into India, manufacturers have to fulfil all the standards of quality & efficacy to enter the Indian market. In India, the Distribution, Sale, Manufacture, and Import of Cosmetics, Drugs, Medical Devices, and IVDs are regulated under the provisions of the Drug & Cosmetics Act, 1940 and Rules, 1945. In the case of importation of Medical Devices into India, then it is necessary to obtain Medical Device Import License under CDSCO; then, only you can import the medical devices into India.

The Central Government supervises regulatory control over these articles imported into India through CDSCO, which is overlooked by the DCGI. The sale, manufacture, and distribution of Medical Devices are primarily regulated by the State Drug Control Authorities appointed by the State Governments. The primary objective of obtaining a Medical Device Import License in India is to ensure the availability of secure, potent & quality medical devices based on scientific excellence & best possible regulatory practices.

Which Regulatory Bodies are primarily responsible for Medical Device Import License in India?

Following are the primary regulatory bodies that are accountable for CDSCO Medical Device Import License in India:

1. The Drug Controller General of India (DCGI);
2. The CDSCO (Central Drug Standards Control Organisation);
3. In India, the import, manufacturing, sale & distribution of different medical devices are regulated or controlled under India’s Drugs & Cosmetic Acts and Rules.