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Certificate of Conformity (CoC)

What is a CoC?​

A Certificate of Conformity (CoC) is a third-party certification confirming that the medical device and its manufacturer's quality system conform to recognised international standards.

What does CDSCO accept?​

For import licence applications, CDSCO typically accepts:

  • ISO 13485:2016 quality management system certification (from an accredited certification body);
  • CE marking documentation (Declaration of Conformity + Notified Body certificate for Class I SR/M through Class III EU MDR);
  • US FDA 510(k) clearance or PMA approval;
  • TGA conformity assessment certificate (Australia);
  • PMDA approval certificate (Japan).

Role in the application​

The CoC (or equivalent conformity evidence) demonstrates that the manufacturer has a functioning quality system and that the device meets applicable safety and performance standards. For Class C and D devices, CDSCO may require more detailed quality system evidence.

Validity​

ISO 13485 certificates are typically valid for 3 years with annual surveillance audits. Ensure the certificate is current at time of CDSCO submission.