Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union in February 2020

 

Dear colleagues,

I am pleased to deliver my usual end-of-the-month update on the highlights of medical device regulations in Russia and the Eurasian Union.

  1. Updated Criteria for Software as Medical Devices in Russia

On the 14th of February 2020, the Russian medical device regulator Roszdravnadzor published a letter that clarifies the criteria by which software may be considered a medical device (and require registration) and annulled previous requirements that had been applied to software since December 2015.

According to the letter, the Russian medical device regulator considers software to be a medical device when it meets all of the following criteria:

  • It is a computer program or its module (regardless of the program’s hardware platform and/or mode of distribution);
  • It is intended by the manufacturer to be used for medical care;
  • It is not a component of another medical device; and
  • It is intended to interpret sets of data received from medical devices, or entered by medical professionals, with the intention that the interpretations will be used for medical purposes.

According to several examples provided in the published document, medical software is not considered a medical device if it is intended for:

  • Hospital administration
  • Health and lifestyle management
  • The archiving and administration of medical data and medical images without the intention of interpreting them
  • The control and technical maintenance of medical equipment
  • Communication between doctors and patients
  • Educational and informational use
  • Receiving data from medical devices but not for medical care.

It should also be noted that, earlier in January 2020, the Roszdravnadzor announced plans to simplify the approval process for some IT healthcare products in Russia and to create a dedicated working group to discuss the registration of medical software.

  1. Draft on the Amendment to the Eurasian Medical Device Registration Procedure

On the 18th of February, the Eurasian commission published a draft document on an amendment to the rules of registration and examination of medical devices in the Eurasian Union (link in Russian). The current version of these rules (Regulation 46) is available in English.

The published draft suggests several clarifications and amendments to the definitions used in the regulations, as well as a clarification of the procedure by which member states accept registrations. It also suggests a protocol for making, and providing notification of, amendments to the registration dossiers of devices, and a clarification of the procedure for cancelling registration certificates.

The document is open for public discussion until the 20th of April 2020.

  1. Update on the Regulation of Medical Devices with Ethyl Alcohol

On the 9th of February 2020, the Russian healthcare regulator Roszdravnadzor enforced regulation 7975 ‘On approval of the regulation on the commission for the formation of a list of alcohol-containing medical devices, the production of which is not covered by the Federal law on the regulation of ethyl alcohol’ (Link in Russian).

Roszdravnadzor published a reminder to the industry that the process of forming this list is carried out on the basis of applications from manufacturers, or their authorized representatives, that are submitted to Roszdravnadzor between the 1st of January and the 30th of June.

It should be noted that the rules for the formation of the aforementioned list were enforced previously in July of 2019. Medical products included in this list are excluded from general alcohol regulations, such as Federal law 171, in Russia. According to this law, ‘alcohol-containing medical devices’ are medical devices in liquid form containing the pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol.

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Some other minor updates over the last month merit mention: Clarification letters have been published by the Russian Ministry of Finance regarding the application of a reduced tax rate for some medical devices (link in Russian). The tax rate for medical devices that will be applied after 2022 (link in Russian) and for custom-made medical devices (link in Russian). Several administrative regulations regarding the control of medical devices have also been cancelled (link in Russian) and replaced by new editions (link in Russian).

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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Three Things You Should Know about Medical Device Regulations in Russia, February 2018

Dear colleagues,

Welcome to my monthly update!

One may note that February 2018 was a fairly quiet month in the regulatory landscape for medical devices in Russia. However there are several recent minor updates which may be of interest:

  1. Updated List of Medical Products Taxed at 10% VAT

At the end of January 2018, the Russian government updated resolution # 688 with a list of medical products taxed at the reduced rate of value added tax (VAT) of 10% (link of updated resolution in Russian). An updated consolidated version of the list was aligned with the new national classification of products (enforced since January 2017).

In this context it should be recalled that Russian legislation grants VAT preferences (0% or 10% VAT instead of 18% as a ‘general rule’) for importing and selling most types of medical devices. The list of medical devices taxed at 0% was last updated in November 2017.

 

  1. List of Alcohol-Containing Medical Devices

At the end of January 2018, the draft regulation, ‘on formation of the list of alcohol-containing medical products’ (link in Russian), was published. According to the document, medical devices ‘in a liquid form of release containing the pharmaceutical substance of ethyl alcohol’ should be included in the special list by special commission of the Ministry of Health depending on a number of criteria (volume of consumer packaging, cost and functional purpose of a medical device). The commission is expected to revise the list no more than once a year and no later than 31st March. It is also expected that medical products included in the list will not be regulated by the Russian Law on State Regulation of Production and Turnover of Ethyl Alcohol and Alcohol-Containing Products, which was amended in January 2018.

 

  1. Weighted Average Prices for Polyvinylchloride Plastics Consumables

On 1st February 2018, the Russian Ministry of Health of the Russian Federation published a letter (link in Russian) proposing the updated weighted average prices for foreign disposable medical devices made of polyvinyl chloride plastics (PVC).

The weighted average prices are used for calculation of the guaranteed maximum price for state and municipal purchases according to the methodology provided in Order № 759N (link in Russian) by the Ministry of Health and the Ministry of Industry and Trade in October 2017.

A new scheme for the public procurement of consumable medical devices made from PVC was introduced in Russia in August 2017 with significant extension of the previously adopted Resolution No. 102 ‘On Establishing Access Restrictions for Certain Types of Foreign-Made Medical Products to Procurement for State and Municipal Needs’.

 

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