The Ministry of Health of the Russian Federation has made a proposal to transfer the procedure for registering medical devices (MD) into electronic form. For now, changes are planned only for medical devices registered in accordance with a facilitated procedure.
Amendments are planned to be made to Resolution No. 552 of 04/01/2022, which regulates the specifics of the circulation of medical devices in case of their deficiency (shortage of suggestion in the market) or a risk of deficiency. The deficiency of these devices arose due to the introduction of economic restrictive measures against Russia.
In case of electronic registration, documents will need to be submitted on the Unified State Services portal through personal account. Documentation will need to be submitted either in the form of electronic documents or in the form of electronic images of documents signed with the applicant’s electronic signature. Changes to registration documents will also be made through your personal account. The registration certificate will be issued to the applicant in electronic form.
You can learn more about the amendments and the rules for submitting documents for registration in electronic form on the website of the Federal Portal of Draft Regulatory Legal Acts.
If the amendments are adopted, they will come into force on April 1, 2024. Registering medical devices using facilitated procedure is permitted until January 1, 2025.