Medical Devices (HCE)

Health Care Equipment is subject to the State Food and Drug Administration’s (SFDA) regulations. In this regard, please refer to our Approval for Medical Devices flyer.

Some medical devices also need CCC, as outlined in the category 17 of the CCC Catalogue:
- Medical diagnostic X-ray equipment
- Haemodialysis equipment
- Hollow fiber dialysers
- Extracorporeal blood circuit for blood purification equipment
- Artificial heart-lung machine
- Electrocardiographs
- Implantable cardiac pacemakers

If not mentioned here, the device might not need the CCC certification.

Quality Partnerships
helps you
identify which license schemes are required for your products, initiate the relevant procedures and reach successful medical devices certification in China.