China CCC Mark Certification for Medical Devices

Through our office in Beijing, we can help medical device manufacturers obtain the CCC Mark for their medical device. The Chinese CCC Mark certification stands for China Compulsory Certification. The CCC Marking applies to a broad range of automotive, toy, home decor, wireless, machinery, safety and other products, but only to a select (but growing) group of medical devices, most of which have an electrical component.

Obtaining the China CCC Mark certification can be challenging for those not familar with the processes of the State Food and Drug Administration (SFDA). All devices that need Chinese CCC certification must be tested by a lab in China. If you do not have local contacts that know how to manage this process and speak Mandarin, the testing approval process would be very difficult.

Our team of China CCC Mark certification consultants specialize in guiding companies through the process, providing a wide range of services from creating the necessary Product Registration Standard to SFDA coordination and document translation. We can also act as your regulatory Legal Agent and After Sales Agent in China.

Please contact us for more information on China CCC Mark certification and SFDA approval.