.png)
Obtaining a medical device manufacturing license in India is a complicated process that requires extensive documentation and compliance with regulatory requirements. The CDSCO medical device manufacturing license is necessary to ensure that medical devices being manufactured meet certain quality and safety standards. Companies must ensure that their products are in compliance with the regulations laid down by the CDSCO before they can be marketed in the country.
The documentation needed to apply for a license to manufacture medical devices
To apply for a Medical Devices Manufacturing License, an applicant must provide extensive documentation to demonstrate compliance with regulatory requirements. This includes information about the premises, the company's legal structure, the identities and qualifications of the staff, technical information about the manufacturing process, and various certifications and approvals from relevant government agencies. The documentation must be self-attested, and applicants must pay a license fee and any additional charges.
Applicable Forms for Manufacturing License
The licensing process differs depending on the risk classification of the medical device.
For Class A and Class B medical devices, the manufacturing license is regulated by the State Licensing Authority, and companies must fill out Form MD-3 to obtain a license, which is issued on Form 5.
For Class C and Class D medical devices, the manufacturer must submit an online application using Form MD-7 to the Central Licensing Authority of the Ministry of Health and Family Welfare of the Central Government to obtain a medical device manufacturing license. The license is issued in form MD-9 once the application is approved.
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 13485-compliant 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.
About Regulatory Solutions India
Regulatory Solutions India (RSI) offers technical, strategic, and project management support to companies seeking to register their medical device with CDSCO. With their vast experience in registrations with CDSCO, RSI assists clients throughout the entire lifecycle, from application preparation to obtaining successful registrations for marketing products in India. Since their establishment in 2011, RSI has registered over 400+ products, including Medical Devices, IVD, and Cosmetics, across 25+ categories for clients from 15+ countries.
Comments