Q&A about Clinical Trials of Medical Devices in China
Q: Can I select similar products as the control products according to Chinese regulations, when conducting parallel controlled clinical trials, if I cannot use the similar products on the market as the control products due to reasonable grounds?
A: For the issue above, you can take following factors into account comprehensively, such as product design characteristics, pre-clinical trial results, risk-benefit analysis, clinical trial purpose, clinical trial evaluation indicators and follow-up time.
It is considered to select similar products on the market whose efficacy and safety have been recognized, whose scope of application is the same as that of the test device, and whose evaluation indicators set in clinical trials are comparable to those of the test device as control products.
Q: Whether the non-Chinese clinical trial data of the product must fully meet the requirements of the corresponding Chinese guidelines or not, for products with existing clinical trial data of non-Chinese medical devices, if there are also published clinical trial guidelines for corresponding products in China?
A: Clinical trials conducted outside China may meet the technical review requirements of the original country where the trial is conducted, but may not fully meet the relevant review requirements of China. For example, when designing clinical trials, some countries only require clinical trials to conclude that the performance of the device meets a certain endpoint.
However, when applying for registration in China, the performance of the device may be required to reach multiple observation endpoints to confirm its effectiveness, and the safety of the medical device need to be supported by appropriate evidence.
If the guidelines for technical review of specific medical devices issued by Chinese NMPA (National Medical Products Administration) contain relevant requirements for their clinical trials, you should consider relevant requirements for the non-Chinese clinical trials of medical devices. In case of any inconsistency, you should provide sufficient and reasonable grounds and basis.
Q: Is it necessary to include the Chinese trial data in the non-Chinese clinical trial data when accepting the clinical trial data of non-Chinese medical devices?
A: It is not necessary to include the Chinese trial data in the non-Chinese clinical trial data when accepting the clinical trial data of non-Chinese medical devices.
According to the Guidelines for Accepting non-Chinese Clinical Trial Data of Medical Devices, the factors that may affect the results of clinical trials are not limited to ethnic differences, and you should consider the effects comprehensively according to product characteristics such as differences in test population and clinical trial conditions.
Although we all know that these factors exist objectively and will have a certain impact on clinical trials, the determination of the influential degree of each factor should also be carried out in combination with the characteristics of the instruments to be declared, the purpose of clinical trials, etc.
According to the development status of medical devices, clinical usage experience, as well as the knowledge of related diseases and diagnosis and treatment methods, it is not necessary to prove one by one if you can judge that it has no practical clinical significance on the clinical trial data of most medical devices.
The applicants should clarify the methods to reduce or eliminate the impact of various differences, such as subgroup design of the subject population or subgroup analysis of existing, clinical trial data.
Q: Are the medical devices listed in the Catalogue of Class III Medical Devices Requiring Clinical Trial Approval required to carry out clinical trials in China?
A: According to the Technical Guidelines for Accepting Non-Chinese Clinical Trial Data of Medical Devices, you can submit non-Chinese clinical trial data in accordance with these Guidelines for medical devices listed in the Catalogue of Class III Medical Devices Requiring Clinical Trial Approval.
Following ethical principles, legal principles and scientific principles, you do not have to carry out clinical trials in China if the non-Chinese clinical trial data meet the relevant technical requirements for registration in China and the data are scientific, complete and sufficient.