How to get CDSCO NOC for Medical Devices?

Notified medical instruments are classified as drugs under the 1940 Drugs and Cosmetic Act and Rules established in 1945. The surgical bandages, surgical staples, ligatures, surgical sutures, blood collection bags, blood component collection bags, and compounds used in-vitro and in surgical dressings are included in the sub-clause (i) of the Drugs and Cosmetic Act, 1940 and 1945.

The department of medical devices discharges the following roles:

This division of the CDSCO issues licenses to medical device manufacturers for use in conducting clinical investigations, tests, evaluations, and other reasons.

This medical devices division issues licenses to import medical devices for use in conducting clinical investigations, tests, evaluations, and other reasons.

. A clinical assessment of a brand-new in-vitro diagnostic medical instrument is also permitted.

It allows for the manufacture or importation of medical devices of a comparable type. This section grants approval to manufacturers or importers for the new in-vitro diagnostic medical device's sale or distribution.

The medical device section verifies the registration of candidates who have applied to the laboratory for testing medical devices.

It creates FAQs and directions on significant topics.