Procedure to obtain a medical device manufacturing license

Obtaining a medical device manufacturing license in India typically involves several steps, including submitting the application online, uploading necessary documents, scrutiny of the application, audit of the applicant’s premises by a notified body, scrutiny of the details of the products applied to ensure compliance with norms, and grant of the manufacturing license.

Role of ISO 13485 in obtaining manufacturing license for medical devices in India

ISO 13485 is not mandatory for manufacturing medical devices in India but is highly recommended as it demonstrates a commitment to quality and safety and can help companies meet regulatory requirements. Many countries, including the USA and the European Union, require medical device manufacturers to have an ISO 13485compliant QMS in place, and CDSCO recognizes ISO 13485 as a standard for QMS for medical device manufacturers. It is recommended to comply with the standard, have a robust QMS system, and increase the chances of getting a license from CDSCO.