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

While ISO 13485 is not a mandatory requirement for manufacturing medical devices in India, it is highly recommended as it demonstrates a commitment to quality and safety and can help companies to meet the regulatory requirements for medical device manufacturing. Many countries, including the United States and European Union, require that medical device manufacturers have an ISO 13485-compliant QMS in place. So, if a company or a manufacturer wants to export its products to other countries, it should comply with ISO 13485. Additionally, CDSCO also recognizes ISO 13485 as a standard for QMS for Medical Device manufacturers. Hence, it's always recommended to comply with the standard to have a robust QMS system in place and increase the chances of getting a license from CDSCO.