CFDA adjusts some administrative approval procedures for medical devices

China Food and Drug Administration (CFDA) recently issued The Decision of China Food and Drug Administration on Adjusting Some Administrative Approval Procedures for Medical Devices (CFDA order No. 32), to adjust CFDA’s administrative approval procedures for the approval of clinical trials, the approval of registration renewal, and the approval of registration alteration of medical devices, it is implemented from July 1^st 2017.
In accordance with the CFDA Decision, Center for Medical Devices Evaluation (CMDE) will represent CFDA to approve the following administrative approval items:

• Approval of clinical trial for the High risk Class III medical devices
• Approval of registration alteration (administrative approval items) for the domestic class III medical device or imported medical devices(class I, II and III medical device included)
• Approval of registration renewal for the domestic class III medical device or imported medical devices(class I, II and III medical device included)

How it works along the new administrative approval procedure

The registration alteration for administrative approval items

The List of High risk Class III Medical Devices requiring clinical trial pre-approval

1. Implantable pacemakers and defibrillators
2. Implantable blood pumps
3. Drug infusion systems
4. Biodegradable stents
5. Prosthetic heart valves
6. Nano-orthopedic implants
7. 3D-printed orthopedic implants
8. Vascular staplers not yet on the market

Manufacturers of these devices must apply to the CFDA for clinical trial authorization before they begin such clinical trials.