Leading regulatory agencies of the world came to the IMDRF Forum, organized by Roszdravnadzor in Yekaterinburg

The 16th meeting of the International Medical Device Regulators Forum (IMDRF-16), chaired by the Russian Federation, opened today in Yekaterinburg.

On September 17, 2019 in Yekaterinburg, the 16th meeting of the International Forum of Medical Device Regulators (IMDRF-16) was launched under the chairmanship of the Russian Federation, in the framework of which the Open Forum of Stakeholders was held (hereinafter – the Forum).

The Forum, organized by Roszdravnadzor and the Ministry of Health of Russia, 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.

The head of Roszdravnadzor Mikhail Murashko addressed the Forum with a welcoming speech on behalf of the Russian Federation and the Federal Service for Supervision of Healthcare. In his speech, he noted that the dates of the Forum were not chosen by chance: on September 17, World Patient Safety Day is celebrated for the first time, which is primarily aimed at reducing the risk of adverse events related to the provision of medical care to an acceptable risk and raising global awareness . “Ensuring patient safety is recognized as a serious challenge to the effectiveness of public health worldwide,” emphasized Mikhail Murashko. – Health systems operate in the rapidly changing conditions of the emergence of new technologies and types of treatment, which, being promising, can simultaneously become sources of new threats to safe care. The last sad example of this is the incident in Voronezh, when the patient died due to malfunctioning medical equipment. “We cannot allow a similar tragedy to happen and in this regard, at the current meeting of the IMDRF, special emphasis will be placed on the safety of medical care in general and medical devices in particular.”

Also, welcoming remarks to the event were made by the Assistant to the Plenipotentiary Representative of the President of the Russian Federation in the Ural Federal District Anna Lenskaya and the Deputy Governor of the Sverdlovsk Region Pavel Krekov.

The plenary session highlighted the main changes in the legislation governing the circulation of medical devices in IMDRF member countries: Australia, Brazil, Canada, China, the European Union, Japan, the Russian Federation, Singapore and South Korea.

Members of the IMDRF working groups spoke about the status of a number of ongoing IMDRF projects related, in particular, to the development of requirements for the documentation provided for regulatory purposes and the structure of the registration dossier of a medical device, the terminology of adverse events arising from the use of medical devices, the implementation and application of good regulatory practices and standards. Presentations were made on the issues of handling personalized medical devices, the clinical evaluation of medical devices, and cybersecurity.

Also, the representative of the new working group “Principles for the Classification of Medical Devices for In Vitro Diagnostics”, created in March 2019 in accordance with the decision taken at IMDRF-15, highlighted the group’s first results and plans for next year.

In addition, the Forum participants were provided with information on the activities and achievements in the field of the circulation of medical devices by representatives of interested parties and stakeholders – the Ministry of Industry and Trade of the Russian Federation, the World Health Organization (WHO), Asia-Pacific Economic Cooperation (APEC), the Asian Working Group for harmonization, Pan American Health Organization, DITTA Manufacturers Association, GMTA Alliance of Manufacturers, International Development Association Cheeks, manufacturers and users of medical equipment (MOMT).

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.