December 24, 2019
On September 17th, IMDRF, the International Medical Device Regulators Forum, has passed the proposal of Medical Device Clinical Evaluation, with unanimous approval of the IMDRF members. This proposal is written by Medical Device Clinical Evaluation Working Group, which is led by China NMPA.
The proposal consists of three parts: “Clinical Evidence – Key Definitions and Concepts,” “Clinical Evaluation” and “Clinical Trial”, and each part focuses on the following three key themes: Basic Requirements for Demonstrating Equivalence of Declared Devices and Comparative Devices During Clinical Evaluation; Principles for Decision-Making in Conducting Clinical Trials of Medical Devices; Principles for Accepting Data From Overseas Clinical Trials of Medical Devices.
In the next step, China NMPA would bring up the draft guidance of “Post Market Clinical Follow-up studies”. With the approved proposal of clinical evaluation, the world is one step closer to the harmonization of medical device regulation.
The three guidance that IMDRF has approved will be published on IMDRF’s website (https://www.imdrf.org). The access link of three guidance are as below.
The Final Documents of Clinical Evaluation Are Released on IMDRF Official Website
IMDRF, Clinical Evaluation, NMPA