What is a CDSCO Manufacturing License for Medical Device?
The Central Drugs Standard Control Organization (CDSCO) is the regulatory body in India responsible for the registration and regulation of medical devices. In order to manufacture medical devices in India, companies must obtain a manufacturing license from CDSCO.
How to Register for CDSCO Manufacturing License?
To register for a CDSCO manufacturing license in India, determine the specific license type, ensure your facility meets eligibility criteria and GMP guidelines, employ qualified technical staff, and submit a comprehensive application, including Form 27, prescribed fees, site master file, premises details, and manufacturing process information to the relevant State Drug Control Department or CDSCO, depending on the type of license required.