CNCA Announced Changes to CCC Product Categories for Medical Devices in China

by G&M Compliance (May 13, 2013)

CNCA announced on May 1st, 2013 that eight (8) types of medical devices no longer fall under mandatory CCC Certification. The food and drug supervision bureau of China and the CNCA both support this change. According to relevant regulations of the “Certification and accreditation regulation of the People’s Republic of China”, “Regulations on the supervision and administration of medical devices” and “Mandatory product certification regulations”, eight (8) types of medical devices no longer require to implement the certification and management of compulsory certification product and Incorporate in the medical device registration management as of May 1st, 2013.

Assigned certification bodies will no longer implement mandatory CCC certification for the below list of medical devices. Furthermore, existing CCC certificates will be canceled by the authorities. Companies who have already received CCC certificates for their products that fall under this list of medical devices should return their purchased but unused mandatory product certification marks to the Mark grant management institutions to receive a refund.

Below are the 8 types of medical devices no longer requires CCC certification:

1. Medical X-Ray Diagnostic Devices
2. Hemodialysis Devices
3. Hollow Fiber Dialyzers
4. Blood Purification Devices
5. Ariticial Heart-Lung Devices
6. Electro-cardiogram (ECG) Devices
7. Implantable Cardiac Pacemakers
8. Latex Condom

For more information, please contact G&M Compliance, Inc. at 714.628.1020