Catalogue of non-commissioned medical devices produced by the State Pharmaceutical Product Supervision and Administration

Catalogue of medical devices prohibited from being commissioned for production

First, some implant materials and artificial organ medical devices.

1. Vascular stent and vascular stent system (except peripheral vascular stent);

Cardiac occluder and cardiac occluder system;

3. Artificial heart valve;

4. Plastic implants (medicines).

Second, allogeneic medical devices

Third, some animal-derived medical devices.

1. heart, nerve and dura mater repair materials;

2. Artificial skin;

3. Use hemostatic and anti-adhesion materials in vivo;

Bone repair materials;

5. Other implantable medical devices directly derived from animal tissues.

Fourth, others.

1. Pacemaker;

2. Implantable blood pump;

3. Implantable insulin pump.

Notice from China Food and Drug Administration on Publishing the Catalogue of Medical Devices Prohibited from Entrusted Production (No.2014 18).