For the import of medical devices in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules. For import of medical device, the manufacturing site and products (medical devices) are required to be registered with Indian drug regulatory agency (i.e. Central Drugs Standards Control Organization).
Any person/firm/enterprise etc. having wholesale license and/or manufacturing license issued under Drugs and Cosmetics Act, 1940 and Rules 1945 can be an applicant for Registration and import of medical devices license into India.