On September 19, 2019, the final meeting of the Steering Committee of the International Medical Device Regulators Forum (IMDRF) took place in Yekaterinburg
On September 19, 2019, the final meeting of the Steering Committee of the International Forum of Medical Device Regulators (IMDRF) in Yekaterinburg was held, organized by Roszdravnadzor.
At the meeting, the final versions of the following documents prepared by the working groups were reviewed and approved by the IMDRF Steering Committee:
– “Clinical data – key definitions and concepts”;
– “Clinical evaluation”;
– “Clinical researches”.
In connection with the election of Singapore by the chairman of the IMDRF Steering Committee next year, the next meeting of the IMDRF Steering Committee will be held from March 16 to 19, 2020 in Singapore.
Information from Roszdravnadzor: The International Forum of Medical Device Regulators (IMDRF) was established in October 2011 with the goal of harmonizing internationally the regulatory requirements for the circulation of medical devices (market access, quality control, safety, effectiveness, etc.).
The Forum Steering Committee (IMDRF Management Committee) currently includes official representatives of 10 regulatory authorities in Australia, Brazil, the European Union, Canada, China, the Russian Federation, Singapore, the USA, South Korea and Japan.
Forum official observer is the World Health Organization (WHO). Affiliates are APEC (represented by the Life Sciences Innovation Forum), the Asian Harmonization Working Party, and the Pan American Health Organization.