The new “Regulation for Medical Device Administration and Supervision”, Order 739, effective since June 1, 2021, allows the implied permission for class III devices conducting clinical trial. It states that, once the receipt of Clinical Trial Application is received, the sponsor can initiate clinical trials after waiting 60 days, in the absence of a rejection or deficiency notice.
It significantly shortens the timeline for clinical trials and accelerates the market introduction for medical devices and IVDs. Previously, the manufacturers had to wait for a formal approval letter from the NMPA to begin their clinical research. Frequently, due to backlog of applications and shortage of the reviewing staff, the manufacturers experienced significant delays waiting for NMPA’s approval.
Class III Devices Going Through Implied Permission
The Center for Medical Device Evaluation (CMDE) website lists the following devices which received implied approval after the policy is implemented:
- Fully degradable peripheral blood vessel drug-eluting stent system
- Absorbable drug-eluting coronary stent system
- Iron-based absorbable stent system
- Personalized skull repair system
- Implantable magnetic fluid suspension left ventricular assist system
- Personalized dental implants
- Transcatheter prosthetic tricuspid valve
Check List for Application
Before submitting a Clinical Trial Application, sponsors are encouraged to contact CMDE. During the 60-day period, NMPA has an opportunity to review the application for safety to assure that research subjects will not be subjected to unreasonable risk. The analysis items include:
- the equipment and professionals of the institution that undertakes the clinical trial
- the degree of risk of the medical device
- the implementation plan of the clinical trial
- the comparative analysis report of clinical benefits and risks
If no rejection or deficiency notice are issued, CMDE will publish the application number, address of applicant, name of medical device, model number and its configuration on CMDE website.
Not all of them require NMPA clinical approval to begin clinical trial but for some there is an extra step. For the Catalog of Higher-Risk Class III Medical Devices Requiring Clinical Trial Approval, please email info@ChinaMedDevice.com.