China FDA Releases Guidance on Accepting Foreign Clinical Data for Devices

China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to remove barriers to expediting reviews.

It recently released technical guidance that outlines requirements for those planning to submit foreign clinical data, and said the efforts will also help to avoid duplication for companies conducting global clinical trials.

The new guidance provides details on the clinical trial data needed to assess safety and efficacy of medical devices and in vitro diagnostics intended for registration in China.

The guidance notes that clinical trials conducted abroad should conform to CFDA good clinical practices (GCP). If a trial is conducted in a country that does not have GCP requirements, the differences should be described in detail to demonstrate that they will not have an effect on the authenticity, scientific rigor, and reproducibility of research results, and that human research subjects will be protected.