April 9th, 2018

International Medical Device Regulators Forum (IMDRF) held a meeting in China during March 20 to 22. The current chairman, China FDA, proposed two projects and get the support from all IMDRF members.

The projects was described in brief as below:

1.   IMDRF will renew the international standard list which was approved in 2014, and explore the technical difference among the standards that IMDRF member approve.

2.  IMDRF will explore the basic requirements for clinical trial decision-making and evaluation, including the foreign clinical trial data acceptance.

Reference:

1. The official press on the work of international standard renew.

2. The official press on the work of clinical trial evaluation.