On June 27th, Teleconference of International Medical Device Regulators Forum (IMDRF) Management Committee was held at China Drug Administration. The progress of clinical evaluations of medical devices proposed by China was introduced in the conference.
At present, the working group for IMDRF clinical evaluation projects has been established. The working group includes 27 representatives from all 10 official members of IMDRF, the Pan American Health Organization and two international associations. The Chinese working team led by Center for Medical Device Evaluation includes three research groups which respectively conduct research on the decision-making principles of clinical trials of medical devices, the basic requirements for the equivalence property argumentation of products applied and products listed, and the principles for accepting data of overseas clinical trials. They collected more than 340 clinical evaluation related documents published by IMDRF and its predecessor, Global Harmonization Task Force (GHTF), and IMDRF member countries for reviewing them one by one, obtained review documents (first draft) of clinical evaluation related requirements, proposed suggestions for the preparation of IMDRF documents, and submitted to the working groups for discussion.
Liu Yinghui, Head of the clinical trial project working group of Center for Medical Device Evaluation, said that clinical evaluation is a common topic in various countries and regions to promote innovation, research and development of medical devices and speed up product launch. In recent years, various countries and regions have achieved new progress in the regulatory concepts and methods of clinical evaluation, but the requirements for clinical evaluation are not unified, so it is imperative to formulate international coordination documents in a timely manner. Against such backdrop, as a member of IMDRF, China presented medical device clinical evaluation projects to the conference at the 13th Management Committee Conference of IMDRF held in March this year, and successfully established the projects.
At present, the working group for IMDRF clinical evaluation projects has been established. The working group includes 27 representatives from all 10 official members of IMDRF, the Pan American Health Organization and two international associations. The Chinese working team led by Center for Medical Device Evaluation includes three research groups which respectively conduct research on the decision-making principles of clinical trials of medical devices, the basic requirements for the equivalence property argumentation of products applied and products listed, and the principles for accepting data of overseas clinical trials. They collected more than 340 clinical evaluation related documents published by IMDRF and its predecessor, Global Harmonization Task Force (GHTF), and IMDRF member countries for reviewing them one by one, obtained review documents (first draft) of clinical evaluation related requirements, proposed suggestions for the preparation of IMDRF documents, and submitted to the working groups for discussion.
Liu Yinghui, Head of the clinical trial project working group of Center for Medical Device Evaluation, said that clinical evaluation is a common topic in various countries and regions to promote innovation, research and development of medical devices and speed up product launch. In recent years, various countries and regions have achieved new progress in the regulatory concepts and methods of clinical evaluation, but the requirements for clinical evaluation are not unified, so it is imperative to formulate international coordination documents in a timely manner. Against such backdrop, as a member of IMDRF, China presented medical device clinical evaluation projects to the conference at the 13th Management Committee Conference of IMDRF held in March this year, and successfully established the projects.