The draft government decree "On Amendments to the Government Decree of the Russian Federation dated November 30, 2024 No. 1684" developed by the Russian Ministry of Health was published on the Federal Portal of draft regulatory legal acts - https://regulation.gov.ru/projects/168307/
According to the explanatory note, the initiative was prepared after appeals from associations of foreign manufacturers of medical devices. The Ministry of Health notes that due to the current restrictive measures, market participants have faced difficulties in processing and updating documents confirming the authority of authorized representatives in Russia.
Currently, the Rules for State Registration of Medical Devices stipulate that from September 1, 2026, the registering authority will be able to decide to cancel the state registration of a product if the manufacturer has not made changes to the registration dossier documents after the expiration of the documents confirming the authority of the authorized representative, or has not provided information about its appointment within the established timeframe.
The draft proposes to maintain the possibility of updating information about the authorized representative until September 2027 and to postpone the application of the rule on cancellation of registration for the same period. The Ministry of Health believes that this will allow manufacturers to complete the re-registration of the necessary documents without the risk of losing their registration certificates.
According to the explanatory note, the initiative was prepared after appeals from associations of foreign manufacturers of medical devices. The Ministry of Health notes that due to the current restrictive measures, market participants have faced difficulties in processing and updating documents confirming the authority of authorized representatives in Russia.
Currently, the Rules for State Registration of Medical Devices stipulate that from September 1, 2026, the registering authority will be able to decide to cancel the state registration of a product if the manufacturer has not made changes to the registration dossier documents after the expiration of the documents confirming the authority of the authorized representative, or has not provided information about its appointment within the established timeframe.
The draft proposes to maintain the possibility of updating information about the authorized representative until September 2027 and to postpone the application of the rule on cancellation of registration for the same period. The Ministry of Health believes that this will allow manufacturers to complete the re-registration of the necessary documents without the risk of losing their registration certificates.
