Criteria to avoid new clinical trials for in vitro diagnostic medical devices

4. January 2018

On November 8, 2017, the CFDA (China Food and Drug Administration) issued a notice that aims to facilitate the reference to existing studies in in-vitro diagnostic medical devices. Even further, under certain conditions it may be possible to dispense clinical studies altogether.
The evaluation of the decision that has been made in 2014 has now been completed.

The underlying letter specifies, among other things, the scope, basic requirements and test- as well as evaluation methods that must be met in order for existing studies to be recognized.

In its core, three main aspects were emphasized :

1. The responsibility of the applicant. The applicant in particular is responsible and held liable for the verification and authenticity of the collected test data of the respective study.
2. Chosen studies must show traceability and transparency in the selection of test individuals and samples used.
3. It is required that all studies were conducted with clear clinical evaluation and test methods. In addition, it is necessary for existing studies to refer to a representative and meaningful control study.

For applicants, these decisions can simplify the approval process significantly in the future and reduce both costs and time for CFDA registration .

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