January 11th 2018, China Food and Drug Administration (CFDA) issued announcement about Accepting the Medical Device Oversea Clinical Trial Data Technical Guideline. The article three in this regulation detailed the oversea clinical trial data submission condition and acceptance requirements.
What should include in the oversea clinical trial data (at least): Clinical trial protocol, ethical opinions and clinical trial report. And the clinical trial report shall include the analysis and conclusion for the Complete clinical trial data.
According to the chose clinical evaluation methods, the oversea clinical trial data can be both the clinical trial documents and verification documents that proof the differences between the same variety products and the verified product will not influence the safety and effectiveness of the products. If the oversea clinical trial data function as a verification documents, it should include the oversea clinical data that focus on the comparison of the differences with the same variety products. Also the applicants already have the oversea clinical trial data that can cover the content for the difference tests that need to be conducted after the same variety products comparison.
The oversea clinical trial data should meet the requirements of CFDA registration. The scientific, integrated and sufficient data will be accepted. The overseas test data shall conform to the basic requirements in article 2 of this guideline, however, it should supplement some information according to China's registration related technical requirements.
If the applicants adopt multi-center clinical trial data in both the domestic and overseas at the same time for the application dossiers. It should also clarify the distribution of cases in the territory in order to further evaluate whether it conforms to Chinese registration requirements.
The medical devices listed in the catalog of the class III medical devices that need to be approved for clinical trials may also submit the overseas clinical trial data according to this guideline.