The Federal Service for Supervision of Healthcare announces the 16th meeting of the Forum held on September 16-19, 2019 in Yekaterinburg (hereinafter – IMDRF-16)
The forum was established in October 2011 in order to harmonize internationally the regulatory requirements for the circulation of medical devices (market access, quality control, safety and effectiveness, etc.).
The Forum Steering Committee (IMDRF Management Committee) currently includes official representatives of 10 regulatory authorities of the participating countries, including: Australia, Brazil, the European Union, Canada, China, the Russian Federation, Singapore, USA, South Korea, Japan. The official observer is the World Health Organization (WHO). Regional harmonization initiatives are APEC (represented by the Life Sciences Innovation Forum), the Asian Harmonization Working Party, and the Pan American Health Organization.
The first meeting of the Form Steering Committee, chaired by the Russian Federation, was held in Moscow from March 18 to 21, 2019.
On March 18, a joint seminar of the Working Group on IMDRF Standards and the Global Association of Radiography, Medical IT and Radiotherapy Systems Manufacturers (DITTA) seminars was held on the subject of the final document IMDRF / Standards WG / N51 FINAL: 2018 “Optimizing Standards for Regulatory Use” standards for regulatory use ”). The precursor of the XV meeting of the Forum Steering Committee was attended by more than 200 representatives of medical devices and regulatory authorities from Japan (PMDA), the USA (FDA), the European Union (EU), China (NIFDC) and Russia (Roszdravnadzor).
On March 19, 2019, the XV meeting of the International Forum of Medical Device Regulators (IMDRF-15) started, on the first day of which the Open Forum of Stakeholders took place. On March 20 and 21, 2019, members of the Forum Steering Committee held meetings to discuss pressing issues of the circulation of medical devices.
The Forum was attended by over 300 representatives of the medical device industry, scientific institutions, federal executive bodies, federal state budgetary institutions, foreign regulatory bodies and international organizations from 28 different countries.
Documents and presentations on past events of the Forum can be found in the section “International Forum IMDRF” – “Materials”.
On September 16, 2019, within the framework of IMDRF-16, a seminar will be held organized by the members of the Forum Steering Committee in conjunction with the Global Association of Radiography, Medical IT and Radiation Therapy Systems (DITTA) Manufacturers on the topic “Artificial Intelligence in Healthcare”.
An Open Stakeholders Forum (IMDRF-16 Open Stakeholders Forum) will be held on September 17, 2019. It is expected that the event will be attended by about 300 representatives of the medical device industry, scientific institutions, federal executive bodies, federal state budgetary institutions, foreign regulatory bodies and international organizations. Also within the framework of the Forum, an exhibition exposition is planned at which Russian-made medical devices will be presented.
On September 18 and 19, 2019, open and closed meetings of the members of the Forum Steering Committee will be held, which will discuss current issues of the circulation of medical devices, make decisions on final documents and discuss new work topics, as well as consider procedural issues of the Forum.
The relevance of participation in the Forum of medical device manufacturers is primarily related to the discussion of the regulatory activities of authorized bodies at the pre-registration and post-marketing stages as part of the event, and, as a result, consideration of the development of common regulatory requirements, that is, regulatory convergence – harmonization at the international level regulation of the circulation of medical devices. The purpose of this approach is the accelerated access to foreign markets of effective, high-quality, safe, as well as innovative medical devices.
Conducting IMDRF-16 in Yekaterinburg will provide medical treatment entities with another unique opportunity for live communication with representatives of foreign regulatory bodies. This interaction experience will give domestic manufacturers of medical devices the opportunity to take a decisive step towards realizing their export potential and familiarize themselves with regulatory practices of world markets.