According to “Guideline on Acceptance of Overseas Clinical Trial Data of Medical Devices” issued on January 11, 2018, Overseas Clinical Trial Data package should include three parts:
1. Clinical trial protocol
3. Clinical study report
The study report shall include the analysis and conclusion for the complete clinical trial data.
According to “Guideline on Acceptance of Overseas Clinical Trial Data of Medical Devices” issued on January 11, 2018, there are three principles:
1. Ethics principle
2. Scientific principle, in terms of clinical trial design, clinical trial outcomes, and benefits and risks of participants.
3. Compliance principle. The overseas trial must comply with “Regulation of Medical Device Clinical Trial Quality Management” issued on March 1, 2016. If not comply, the difference must be demonstrated in detail.
1. Difference in Technical Review Requirements
2. Difference in Subjects (internal factors and external factors)
3. Difference in Clinical Trial Conditions
For multi-center or clinical trials, the following points should be followed:
– The study design should meet the requirements of the multi-center clinical trial in the “Medical Device Clinical Trial Quality Management Practice” (China Medical Device GCP), published on March 1, 2016.
– One clinical trial site should be identified as the lead site. All the sites should use same clinical protocol and conduct the clinical trial in the same period of time, to ensure the consistency of trial implementation and administration of study medical device.
– Statistical analysis principles and methods can follow those of multi-center clinical trial.
– The lead site should compile the clinical trial summaries from other sites and complete the clinical study report (CSR). The CSR should be stamped by all sites.
After signing an agreement or contract with each clinical trial site, the sponsor can file with the provincial drug administration department where the sponsor/agent is located. After the record is filed, clinical trials can be conducted.
When the same clinical trial project was filed for multiple times, the sponsor shall provide all the records obtained previously. The provincial drug administration department shall indicate in the “recording number” column of the “Medical Device Clinical Trial Record Form”, so that the clinical trial record number of the same project can be consistent.
Based on our previous experience, it is very likely that the reviewer only accepts one predicate device for the justification for clinical trial exemption. That is to say, you need to have a NMPA approved product that is very similar to your product structure design.
Simple CER is only a comparison table following NMPA’ s format requirements.
NMPA has a specific requirement for the comprehensive CER format and contents (16 sections). Comprehensive CER could be 50 or more pages long.