On approval of the Procedure for monitoring the safety of medical devices

Order of the Ministry of Health of Russia dated September 15, 2020 N 980n “On Approval of the Procedure for Monitoring the Safety of Medical Devices” establishes the procedure for monitoring the safety of medical devices. except for the territory of the international medical cluster and the territories of innovative scientific and technological centers. The purpose of monitoring is to identify and prevent side effects that are not specified in the instructions for use or the operating manual of the medical device, adverse reactions during its use, the peculiarities of the interaction of medical devices with each other, facts and circumstances that pose a threat to the life and health of citizens and medical workers when using and the operation of medical devices.
Monitoring includes the collection, processing, registration and analysis of information about adverse events, and the adoption of appropriate decisions.

It starts on January 1, 2021 and is valid until January 1, 2027.

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