Tag Archives: labeling

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, March 2021

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Dear Colleagues,

Here is my regular update on the Russian and Eurasian medical device regulations for the last month:

  1. Update on the Eurasian Transitional Period

On 9 March 2021, the Eurasian Commission published Regulation No.28 (Link in Russian) which confirmed and specified deadlines for the Eurasian regulation transition period previously established  as follows:

  • Submissions for registration and expertise of medical devices according to the local rules (of the Eurasian member states) will be open until 31 December 2021.
  • If submitted before 31 December 2021, the registration dossier will be reviewed according to the local registration rules of a member state.
  • Medical devices approved according to the local registration system in the Eurasian member states may stay approved in this member state by the end of validity of the registration.
  • Registration certificates for medical devices registered according to the local rules may be amended (by the local rules) by 31 December 2026.

On 22 March 2021, the Russian Ministry of Health published the draft of amendments of the rules for the state registration of medical devices in Russia (link to the draft in Russian), harmonised with Eurasian regulations and transition deadlines and proposed other amendments. The draft is currently in the discussion stage until 9 April 2021.

Regardless of the approaching end of the transition period, we still may see a limited number of submissions and approvals according to the new Eurasian system.  As of the end of March 2021, there are five records concerning approval of medical/in-vitro devices in the Eurasian Union. All approved devices are manufactured by Eurasian manufacturers.

  1. Extension of the Restriction List for Medical Devices in Russia

On 6 March 2021, the Russian Government released Resolution No.336 (link in Russian), which expanded the list of medical devices originating from foreign countries, subject to restrictions for state and municipal procurements according to Resolution #102.

The new devices added to the restriction list include biochemical analysers, fetal monitors, medical, biological, and clinical microscopes for laboratory diagnostics, ultrasound surgical devices, surgical coagulants, and therapeutic laser devices.

According to Resolution #102, participation in government and municipal tenders for the supply of these products must be rejected if at least two suppliers from Russia or the EAEU countries take part in the auction with a similar type of product.

  1. Kazakhstan Updated Labelling and Advertising Requirements for Pharmaceutical Products and Medical Devices

At the end of February 2021, the Ministry of Health of Kazakhstan released order #KR-DCM -11 (link in Russian) and updated national requirements for the labelling of medical devices. The regulations provide a list of information and symbols required for the manufacturer to state on the label of a medical device. The labelling must be present in Russian and Kazak languages, approved by the competent authority during the registration process and attached to each unit.

Previously, in January 2021, the Ministry of Health of Kazakhstan enforced the order #KR-DCM -11 (link in Russian) and updated rules for advertising medical devices in the country.

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Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, May 2019

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Dear Colleagues,

In my regular post, let me share information on the main developments and changes of medical device regulations in the Russian and Eurasian regions over the past month:

  1. Development of Medical Device Registration and Inspection Regulations in Kazakhstan

Last month, several updates regarding registration expertise and inspection requirements in Kazakhstan were enforced:

On 15 May 2019, a new edition of the Order of the Minister of Health of the Republic of Kazakhstan No. 736 ‘on approval of the rules for examination of medicinal products and medical devices’ (Link in Russian) came into effect.

Earlier, on 7 May 2019, the Kazak Ministry of Health enforced another amendment to the Order No. 743 ‘on approval of the rules for assessing production conditions and the quality assurance system for the state registration of medicinal products, medical products and medical equipment’, which came into force (Link in Russian) and updated the criteria for when an inspection is required for the registration of medical devices and pharmaceutical.

Thus, the Kazak regulator clarified that according to amended regulations, the criteria for the inspection of the registration of medical devices in Kazakhstan is required for registering sterile 2A, 2B and 3 class devices in case a manufacturer has never registered or supplied products in Kazakhstan before.

  1. Update on Eurasian Medical Device Regulations

On 21 May 2019, the Eurasian Economic Commission published Recommendation No. 14 (link in Russian) on ‘the methodological recommendations for the expertise of safety, quality and efficiency of medical products for the purpose of their registration within the Eurasian Economic Union’. This is the third-level document intended to ensure the unification of the requirements for the content of evidence materials submitted for registration expertise across Eurasian member states.

Also, potential prolongation of the transition period until 2026 was announced by the Eurasian commission during the annual regulatory conference FarMedObrashenie in Moscow as one of the possible measures. However, up until today, no official regulations/drafts on this matter have been published (to be recalled that for today, the end of the transition period is set as the end of 2021).

In the same conference, the representative from the Eurasian commission confirmed that four registration files for medical devices are currently under review by the Eurasian competent authorities.

  1. Voluntary Experiment on the Identification Measures for Wheelchairs in Russia

The initiative for additional marking for identifying medical devices has been discussed since the beginning of 2019 and is one of the priorities for  the Russian healthcare regulator as a measure of ensuring traceability and counteract the turnover of counterfeit products on the market.

One of the first steps of this initiative was published by the Russian Ministry of Industry and Trade at the end of April 2019 as the draft resolution of the Government of the Russian Federation “on conducting an experiment on labelling with means of identification and monitoring the circulation of certain types of technical means of rehabilitation (wheelchairs classified as medical devices)” – link to the document in Russian.

According to the published document, an experiment on marking with additional means of the identification of certain types of wheelchairs  will be launched in Russia from 1 June 2019 to 1 June 2021.

Participation in the experiment is to be on a voluntary basis, but it is assumed that the pilot project will determine the feasibility of introducing mandatory and additional identification labelling in the future.

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Thank you for following my blog, which is a non-commercial project.
My objective is to provide clear and up-to-date information on Russian medical devices.
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Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Economic Union, November 2015

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Is it the calm before the storm? In November 2015 we cannot observe major regulatory news and updates for medical devices in Russia and the Eurasian Economic Union countries… In one month’s time the common harmonised market of pharmaceuticals and medical devices will begin functioning (at least formally). Meanwhile, at the current time, there are still a lot of questions to be answered, second-level regulations and guidelines to be published…
Nevertheless, here are some updates which should be useful to know for your Russian regulatory projects:

  1. New version of national standards for labelling requirements for In Vitro devices

In November 2015 the Russian Federal Agency on Technical Regulating and Metrology (Rosstandart) published an updated version of its voluntary national standard GOST R ISO 18133, which is composed of five parts and which contains technical requirements on labelling and accompanying information and documentation for In Vitro Diagnostic (IVD) medical devices (part 1, link in Russian), IVD reagents (part 2, link in Russian), IVD instruments for professional use (part 3, link in Russian), self-testing IVD devices (part 4, link in Russian), and IVD instruments for self-testing (part 5, link in Russian). The new standard will come into force in November 2016 and will replace the version from 2009, which is valid currently. It should be recalled that the use of standards is voluntary, but recommended by Roszdravnadzor as the best way to demonstrate that a medical device meets all labelling requirements during the approval process and into further commercialisation.

  1. Discussions around the Russian product classification code

FullSizeRenderAnother update from the Federal Agency on Technical Regulating and Metrology (Rosstandart) is the extension of validity of the Russian product classification code OKP (ОКП ) until 1 January 2017. The OKP code is a classification code which is present in every registration certificate (in addition to the medical device safety class and nomenclature classification) and is used by customs officials, among others, to define the amount of VAT exemption during medical device import and customs clearance. Previously, the deadline for transition into a new product classification system was set as 1 January 2016, which seemed to threaten a wave of uncertainty in calculation and in applying VAT exemption in practice. It should also be noted that some months ago Roszdravnadzor (the Russian medical device regulator) expressed the opinion that, in future, this code should be removed from the registration certificate.

 

  1. Armenia joins the EEU Agreement for Medical Devices

ArmeniaArmenia ratified the Agreement on common principles and rules of circulations of medical devices signed at the end of last year by EEU countries. In such a way, for November 2015, this agreement is approved by Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia. It should be noted that, at present, unlike in other EEU countries, Armenia regulates the approval process for pharmaceuticals and not medical devices, which suggests quite deep further changes are coming in the medical device sector for the country.

In conclusion, I would like to thank you for the following and remind that you can get regulatory updates about Russian medical device regulations from this blog directly in your e-mail using the ‘Follow’ button in the toolbar in the upper corner of this page.