Post Market surveillance (PMS) for medical devices and IVD in Russia-bg

Post Market surveillance (PMS) for medical devices and IVD in Russia

Post-registration monitoring of medical devices (monitoring) consists of two main parts:

  1. Monitoring of safety and clinical effectiveness by the manufacturer and the authorized representative of the manufacturer;
  2. Monitoring compliance with mandatory requirements by Roszdravnadzor, including collecting data from patients and medical workers on the used medical devices.

The main purpose of monitoring is to ensure the safety and effectiveness of the use of MD.

Among the monitoring procedures, for example, the following can be highlighted:

  1. Unregistered MD;
  2. Non-compliant MD;
  3. Falsified MD;
  4. Substandard MD and/or model of MD;
  5. New data on the safety of MD.

Based on the identified circumstances, for example, it can be initiated:

  1. Recall of the MD;
  2. Suspension of use of the MD;
  3. Withdrawal of the MD from circulation;
  4. Conducting corrective measures;
  5. The beginning of the procedure for making changes to the registration dossier.

During the monitoring process, Roszdravnadzor, the manufacturer of MD and AR are obliged to work closely together to prevent the appearance of substandard and other MD on the market.

Of the monitoring procedures, the following can be highlighted, for example:

I. Accomplished by the manufacturer or the AR

  1. Submission of reports to Roszdravnadzor on import or commissioning of MD in accordance with the Order No. 11020 of 25.10.2021
  2. Submission of reports to Roszdravnadzor within 3 years on clinical use of MD of risk class 2b implantable and 3 in accordance with the Order No. 1113 of 19.10.2020

II. Accomplished by Roszdravnadzor

  1. Conducting Federal State control (vigilance) over the circulation of medical devices by Roszdravnadzor
  2. Maintaining registers containing information about adverse events/recalls of MD, etc.

Post-registration monitoring is an important tool for ensuring the safety and quality of medical devices. It allows you to timely identify and eliminate problems associated with their use, and thereby prevent undesirable effects and other negative consequences.

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