Mortality from adverse events in the use of medical devices will be included in the indicators of state control

The Ministry of Health of the Russian Federation will add to the list of key indicators of state control over the circulation of medical devices the number of patients who died as a result of adverse events when using such devices. The value will be determined in terms of 1 million people, the target is defined as a maximum number of 0.7 people in 2022 with a decrease to 0.55 by 2025.
Amendments are planned to be made to the Regulation on Federal State Control over the Circulation of Medical Products, approved by Decree of the Government of the Russian Federation No. 1066 of June 30, 2021.

The value will be calculated on the basis of messages sent during the reporting year to Roszdravnadzor by subjects of medical devices circulation. The target is expected to be approved at a level of no more than 0.7 per 1 million in 2022, 0.65 in 2023, 0.6 in 2024 and 0.55 in 2025.

If approved, the amendments to the government decree will enter into force on March 1, 2022.

At the end of June 2021, the Government of the Russian Federation approved the updated Regulation on state control over the market of medical devices. In the new edition, the intervals of inspections have been increased – they will be carried out once every 4-10 years for participants in the market of medical devices classified as moderate, medium and significant risk. The state control includes new oversight mechanisms – a preventive and inspection visit, as well as test purchases, which will be carried out by Roszdravnadzor.