Is ISO 13485 Mandatory for Class A and B Devices?

An ISO 13485 certificate is not legally mandatory for Class A and B medical devices, but it becomes essential when demonstrating compliance with specific regulatory frameworks or when required by a notified body or authority.

Does CDSCO Form MD 7 Require an ISO 13485 Certificate?

No, ISO 13485 certification is not explicitly required for CDSCO Form MD-7. However, having it is highly recommended, as it helps demonstrate compliance with quality standards during audits. While the form does not mandate ISO 13485, aligning with its QMS framework strengthens the application and can significantly streamline the approval process.

Is ISO 13485 Accepted Globally?

Yes. ISO 13485 for medical devices is widely accepted worldwide and serves as the foundation for CE marking, Health Canada, TGA (Australia), and MDSAP requirements. Having this certification simplifies global market access and reduces duplication of audits.