Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, September 2021.

Dear colleagues,

Here is my update on the Eurasian Economic Union’s (EAEU) medical device regulations for the last month:

  1. Revision of the EAEU’s Medical Device Registration Rules

On the 21st of September 2021, the Eurasian Economic Commission (EEC) released regulation 148 (link is in Russian) with an updated revision of the EAEU’s medical device registration rules where they implemented significant changes in its requirements. These changes included the option to register several medical devices with different EAEU codes at once, a change of the established timelines for the steps of approval, updates regarding the procedure of amendment of the registration certificate and clarification on the quality management system inspection procedure.

Earlier, on the 13th of September 2021, the EEC released regulation 22 (link is in Russian) with a guide for inspection bodies of the Eurasian member states (EAEU inspectors)  to conduct inspections/audits of a medical device’s manufacturers’ quality management system.

As of the end of September 2021, seven medical devices have been approved under the EAEU rules.

  • Authorisation for Emergency Importation of a Medical Device for Individual Patients in Russia

On the 22nd of September 2021, the Russian Government released resolution 1590 (link is in Russian). This opens the possibility to receive authorisation for emergency importation of medical devices for particular named patients in the case of a life-threatening medical emergency in Russia. Until this moment, this type of emergency importation was not regulated in Russia.

According to the published procedure, this authorisation is valid for 30 days and should be issued by Roszdravnadzor, the Russian medical device regulator, within five business days after the electronic submission of a dossier. A dossier should include the relevant medical justification on behalf of the clinic, identification documents of the patient, the relevant translated instructions for use or user manual and photos of the medical device.

This law will be implemented on the 1st of March 2022 and will be valid until the 1st of January 2027.

  • Updates of the Local Medical Device Registration Procedure in Belarus

On the 1st of September 2021, the government of Belarus released resolution 504 (link is in Russian) updating local medical device registration rules.
The main changes made are related to the registration requirements of medical devices that are needed for urgent needs , used to provide humanitarian aid and supplied by public health organisations as part of international health programs. This resolution also implemented updates on the registration renewal procedure.

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Thank you for following my blog which aims to provide clear and timely updates on the development of the EAEU’s medical device regulations. Let me also remind you that you can receive updates directly to your email via the ‘follow’ button on the toolbar of this blog.

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