Three Things You Should Know about Medical Device Regulations in Russia: July 2019

 

Dear Colleagues,

This is my usual selection of highlights and recent changes in medical device regulations in Russia:

  1. Some Updates in Medical Device Registration and Clinical Trial Requirements in Russia

On 4 July 2019 the Russian Ministry of Health enforced order no. 239N (link in Russian). This updated certain requirements for pre-registration clinical trials (update of order no. 2N), requirements for the content of the technical file and instruction for registration of a medical device (update of order no. 11N). The main updates implemented in the published document are:

  • The clarification of and uniform requirements for documents confirming the quality of the pharmaceutical component of drug-containing medical devices.
    The first amendments of registration rules (regulation no. 1416) to simplify the registration of drug-containing medical devices in Russia were made in June 2018; later in 2018 Roszdravnadzor clarified requirements for confirming the quality of the pharmaceutical component. However, until July 2019 these registration rules were not harmonised with other Russian medical device regulations (order no. 2N and order no. 11Nr). The order no. 239 seems to finally resolve these discrepancies.
  • Henceforth, it is permitted to conduct clinical trials for registration in Russia where a certain type of capital medical equipment is on-site in other countries in ‘organizations where a medical device is located/installed and is approved for use/application’. The possibility of on-site clinical trials is not new, however, previous revisions of order no. 2N permitted clinical trials to be performed ‘during inspection on the place of the manufacturing of a medical device’.
  1. Russia Launches the List of Medical Devices Containing Ethyl Alcohol

On 2 July 2019 the Russian government enforced resolution no. 774 (link in Russian), which approved the rules for the formation of the list of alcohol-containing medical devices. Medical products included in this list are excluded from general alcohol regulations in Russia i.e the Federal law 171 “On state regulation of the production and circulation of ethyl alcohol, alcoholic and alcohol-containing products and on limiting the consumption (drinking) of alcoholic beverages”. The released resolution provides the criteria for inclusion on the list (based on a product’s intended use, the form of the container or package and the product retail price) along with a list of documents  for application for inclusion. Russian healthcare regulator Roszdravnadzor is responsible for the list’s inclusion procedure and has clarified the rules for applications — which should be received <annually> by the regulator between 1 January – 30 June.

  1. Russia: New Administrative Provision on Medical Device Registration

On 26 July 2019 the Russian Ministry of Health published order no. 3371 (link in Russian) – with a new version of the administrative provision of Russian medical device regulator Roszdravnadzor – on the procedure for the registration of medical devices in Russia. Simultaneously, the previous version of the same document (the Ministry of Health order no. 737) was annulled.

Administrative provision on the procedure for the registration of medical devices is a regulation that establishes the following: the terms and sequence of administrative procedures of the regulator during the approval process, the procedure for interaction between its structural divisions and the interaction between applicants/manufacturers and other government bodies. The new version of administrative provision does not contain critical changes but it is aligned with the last changes of the registration rules and other medical device regulations.

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