(HCE)
- Health Care Equipment is subject to the State Food and Drug Administration’s (SFDA) regulations.
- 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.