In August 2023, Government Decree (GD) No. 1332 was published, containing information on changes to the Regulation on Maintenance Licensing (ML) of Medical Devices (GD No. 2129 of 11/30/2021). After the entry into force of the GD (September 1, 2024), Roszdravnadzor will have the opportunity to make changes to the register related to changing the name of the work performedRead more
Tag Archives: Regulation
In May 2023, Decision No. 60 “On Amendments to the Rules for Registration and Examination of Medicinal Products for Medical Use” was published on the legal portal of the Eurasian Economic Union. By this decision were approved a number of important changes that many members of the regulatory community were waiting for. Firstly, as part of these changes, some termsRead more
According to a Decree of the Government of the Russian Federation No. 894, dated 31 May, 2023, the Rules are set out for the labelling of certain types of medical devices using identification means. This Decree establishes that the parties involved in the circulation of certain types of medical devices shall submit an application to the State Information System forRead more
At the end of May 2023, a letter from the Ministry of Health and the expert center of the Federal State Budgetary Institution ‘SCEEMP’ was published on the State Register of Medicines (GRLS) with clarifications for applicants on the availability of medicines sold without secondary packaging in circulation. What is secondary packaging? According to the information from the general pharmacopoeialRead more
On May 2, 2023, the Ministry of Health of the Russian Federation approved the procedure for importing medical devices for the purposes of state registration. According to Order No. 201n, the applicant must notify Roszdravnadzor of the intention to import medical devices in the electronic form for the purposes of state registration. The notification procedure for the import of unregisteredRead more
Documents confirming the registration of a medical device in the country of origin are not required for registration of a medical device in Russia.
Regarding the national registration of medical devices in the Russian Federation, it is often clarified – is registration required in the country of origin or is a CE certificate, declaration, Free Sale certificate, export certificate and other such documents required? According to the current position of the Federal Service of Roszdravnadzor (the relevant reply to our request was received inRead more
In April 2023, the Ministry of Health of the Russian Federation issued Order No. 95n, which simplifies the procedure for making some changes to the registration dossier for a medicinal product (MP). Thus, the changes have impact on grounds for making changes to the registration dossiers that do not require an examination of quality, efficacy and safety. Now examination ofRead more
Roszdravnadzor issued the first permission to use an unregistered medical device for in vitro diagnostics.
As part of the implementation of Decree of the Government of the Russian Federation No. 2026 dated November 24, 2021 “On unregistered medical devices for in vitro diagnostics”, Roszdravnadzor for the first time issued permission for the use of an unregistered medical device for in vitro diagnostics “A kit of reagents for high-throughput sequencing of human biological material in orderRead more
Rospotrebnadzor plans to amend the technical regulations of the Customs Union “On food safety” (TR CU 021/2011) and “On the safety of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition” (TR CU 027/2012). The changes will concern the production, sale and labeling of dietary supplements. Thus, with the help of amendments to the regulation TRRead more
In November 2022, Roszdravnadzor received a notification from the Novo Nordisk manufacturing company about the planned termination of supplies of the Ozempic drug to the Russian Federation. It should be noted that according to the current legislation of the Russian Federation, the holder of the registration certificate must notify Roszdravnadzor in advance (1 year in advance) of the termination ofRead more