If devices are not on the clinical evaluation exempt catalog but have an NMPA-approved predicate device to show substantial equivalence, per the “Guidance for Clinical Evaluation of Medical Devices” published on Sep 28, 2021, the applicant can use the clinical data of the predicate device as a part or the total clinical evidence of the product to be registered for NMPA registration.
The clinical data of predicate can be used as an alternative to local clinical trial to meet NMPA clinical requirements.
Highlights of the Guideline
- The goal of the clinical evaluation is to demonstrate the safety and efficacy through the equivalency between the product under application and the predicate device.
- The applicant must demonstrate that the product to be registered is basically equivalent to the predicate in terms of application scope, technical and biological characteristics.
- The application scope includes intended use, applicable population, area to be applied to, severity and stage of the disease etc.
- The technical characteristics include but not limited to the product design, working principle, technical specifications, chemical and physical characteristics, key performance requirement etc.
- The biological characteristics include degradation characteristics, biological response etc. If there is any difference, the applicant needs to demonstrate and justify those differences will not have any negative impact on product safety and efficacy.
- If the existing evidence is not sufficient to fill the gap, the clinical evidence of the predicate can be used in combination with other clinical pathways. For example, the gap can be filled through a relatively small-scale clinical study in China. Vice Versa, the clinical data of predicate can be used to reduce the scale of China clinical trial.
- It is recommended to use just one predicate if possible. If more than one predicates are used, the applicant should explain the reasons and make a comprehensive comparison of multiple predicate devices with the product to be registered.
- The similarities and differences between the product to be registered and each predicate device should be described in detail.
- If the information of the predicate device is not publicly available, the applicant will need to obtain an authorization letter from the predicate device manufacturer clarifying that the predicate manufacturer agrees to give access to the applicant for the predicate’s data.
If you have any questions whatsoever about these product registration clinical evidence guideline highlights, please contact us at info@chinameddevice.com.