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 (or ISO 13485:2023) quality management system certification from a certification body accredited by a signatory to the International Accreditation Forum (IAF) multilateral recognition arrangement;

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.