The NMPA published the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” on September 28, 2021, directing manufacturers on how to decide if clinical trial is necessary for certain medical devices. The draft version was released in May, 2021.
“Applicants are encouraged to use the most effective way to demonstrate safety, efficacy and performance of medical device, and eliminate or reduce unnecessary clinical burdens”, the document says. Various methods can be adopted for design confirmation, such as phantom test, computer simulation test, animal test, clinical evaluation, etc. The clinical data that can be used for clinical evaluation include safety and effecacy information generated during clinical use within or outside China, such as clinical trial data, clinical literature data, and clinical experience data.
The necessity of clinical trials should take the following aspects into consideration:
- scope of application
- technical characteristics
- biological characteristics
- degree of risk
- differences with existing medical devices
If the results of non-clinical research and/or existing clinical data are not sufficient to prove the safety, efficacy and performance, clinical trials should be required.
Exceptions for Clinical Trial
Manufacturers are encouraged to use the most effective way to prove the safety and performance of medical devices, which are demonstrated by the clinical evidence and other design verification and confirmation documents, device descriptions, and instructions, etc.
Clinical trial is mandatory for high-risk Class III device, but in three scenarios the clinical trial can be exempted:
a) predicate is marketed in China, and the non-clinical & clinical data, and overseas data can prove the safety and efficacy
b) predicate is not marketed in China, but the non-clinical, clinical trial and overseas clinical data for device can prove the safety and efficacy
c) overseas clinical data acceptance pathway.
If the device is a New Medical Device, clinical trial is necessary. New Medical Device means that, compared with those that have been approved in China, the medical devices have significant differences in scope of application, technical characteristics, and/or biological characteristics. But in three scenarios the clinical trial can be exempted:
a) non-clinical data is enough to prove the safety and efficacy
b) utilizing overseas data pathway
c) predicate product has overseas clinical data