According to the announcement about Accepting the Medical Device Oversea Clinical Trial Data Technical Guideline issued by China Food and Drug Administration (CFDA) on January 11th 2018, there are three main considerations from the CFDA.
Technical review differences is one of the considerations for the acceptance of the oversea clinical trial data. The oversea clinical trial data may confirmed to the technical review requirements in the tests conducted countries, but it may not meet the requirements of CFDA. For example, when conducting clinical trial design, some countries require the clinical trial can conclude the product performance reaches one observation terminal. However, for the CFDA registration, it could require the performance of the product can be verified by multiple observation terminals. And the safety of medical device shall be supported by appropriate evidence. If CFDA issued technical review guidelines for specific medical devices and it contains relevant requirements for its clinical trials, this medical device shall provide sufficient, reasonable reason and basis for the differences about the oversea clinical trial considered requirements.
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