Certain high-risk Class III medical devices will be subject to clinical trial pre-approval under a new catalogue proposed by China’s Food and Drug Administration (CFDA). The Catalogue of Class III Medical Devices Subject to Clinical Trial Authorization was released on September 30, 2013 and includes 15 types of Class III medical devices that would require pre-approval.
Class III medical devices requiring clinical trial pre-approval include:
- Implantable pacemakers and defibrillators
- Implantable blood pumps
- Drug infusion systems
- Biodegradable stents
- Prosthetic heart valves
- Nano-orthopedic implants
- 3D-printed orthopedic implants
- Vascular staplers not yet on the market
Manufacturers of these devices must apply to the CFDA for clinical trial authorization before they begin such trials. After the trials have begun, manufacturers that make “substantive changes” to the study protocol or consent documents must apply for supplemental authorization. Medical device manufacturers that re-start suspended clinical trials must also apply for supplemental authorization. Clinical trial authorization and supplemental authorization will both take 95 days for CFDA approval.