Review of new Eurasian Economic Union Medical Device Approval Process.

click here for this post in Russian

After the approval of the Agreement on Common Principles and Rules for Circulation of Medical Devices (link in Russian) in the EEU in December 2014, the new rules of registration of medical devices for the future harmonized system can be called the most important and anticipated legal act among “second level” regulations. At the beginning of July 2015 the draft of new registration rules was published on the website of the Eurasian Economic Commission.

Here I would like to shortly recap the main innovations of this draft, as well as its most significant differences compared to existing medical device regulatory systems in Russia, Belarus and Kazakhstan which could expect us since January 2016:

  1. Registration acceptance “by default”?

According to the text of the draft, the new rules do not imply a uniform registration throughout the EEU “by default”. At the beginning, the document introduces the concept of “reference state”, a country in which it is assumed the full cycle of medical device registration occurs with the expertise phase and the “acceptance state”, that accepts the results of expertise by the simplified acceptance procedure of 15 business days. According to the draft, a “reference state” and “acceptance state” are selected by the applicant at the beginning of the registration procedure and after registration is fixed on the title of the registration certificate (see Annex 13).
The non-acceptance of the expert opinion of the reference state (see Clause 32) by another state of EEU, according to the draft, could be reason for prohibition of circulation of a medical device in the territory of the individual states of the EEU.
Form the text of the draft it is not clear whether an authorized representative of the manufacturer is required in each country of the EEU, or one across the entire union.


  1. The transitional period

Probably one of the best pieces of news is that according to the draft, at the beginning of 2016, Eurasian regulation changes seem not to be drastic. Clause three of the new rules introduces a transitional period (exact time is not currently specified). According to the project, during this time the registration dossiers can be submitted either in accordance with existing national legislation of the States of EEU or in accordance with the new harmonized registration procedure. Nevertheless it should be noted that in accordance with clause 15 of the agreement on common principles and rules for the treatment of medical devices, current (local) registration certificates of medical devices will be valid until 31 December 2021 at the latest.


  1. New definitions

The draft of new registration rules introduces new definitions for: component parts, modifications, accessories, and consumable materials for medical devices (as well as some other definitions). Up to now these concepts caused a lot of questions during the registration process in Russia, because they were not fixed in regulations.


  1. The procedure for amendment of registration certificate

In Russia today (unlike Belarus or Kazakhstan) there is two separate procedures: amendment in the registration certificate (according to Clause 37 of the current Russian registration rules) and amendments to the registration dossier (according to Clause 55 of the current Russian registration rules). Based on personal experience, such separation of procedures is not always obvious and sometimes causes a lot of additional questions from the medical device manufacturer. The new rules introduce a single procedure for amendments to the registration dossier. The changes, according to the project, can be carried out with or without the issuance of a new registration certificate. The document provides the reasons and pathways for such amendments (see Section IV of the draft).


  1. Classification and nomenclature

According to clause 15 of the new Eurasian rules, “simultaneous submission for registration of several modifications of the medical device belonging to similar types can be grouped in accordance with the medical device nomenclature of the EEU […] the applicant should submit as a single application and a single registration dossier.” It should be recalled that clause two of the previously approved Agreement on Common Principles for the Treatment of Medical Devices requires “harmonization of the nomenclature of medical devices used in the Member States, with the global medical device nomenclature GMDN”. From a practical standpoint, this change may lead to a multiplication of applications for registration (compared to earlier registrations, particularly in Belarus and Kazakhstan). As you probably know, new nomenclature classification of medical devices has recently been adopted and is already working in Russia and Belarus.


  1. Medical device expertise

In contrast to the current regulatory system, the new rules propose one-step expertise of not more than 60 business days. (In comparison, today in Russia and Belarus, the expertise phase of medical devices registration takes place in two stages, with the official time of 15-30 business days and for Kazakhstan, a three-phase expertise, lasting up to 180 days). It’s no secret that in Russia today, the stage of expertise is the most challenging for the registration. Clause 23 of the new rules describes in detail the main steps of the new expertise of medical devices for the registration. In the case of a lack of necessary information, the new rules allow a one-time request for additional materials from the expert organization, with 60 working days for delivery of these materials for the applicant (today the similar timeframe for Russia is 50 working days, and in Kazakhstan, 30 business days). 


  1. Manufacturer inspection

Today, the inspection of the manufacturer is the most difficult stage of the registration of medical devices in Belarus and Kazakhstan, and is used by regulators in a rather limited number of cases. The draft of new rules (see Clause 22) significantly expands the indications for inspections to control the manufacturer’s quality management system, suggesting regulator inspection of the registration of all medical devices of high risk and sterile products of class 2a. Total time for the organization and conduct of such an inspection, according to the project, shall not exceed 90 business days.


  1. Instruction for use and labelling

A new requirement for the medical device system is the approval of the regulator layout packages and instructions for their placement on the official regulator`s website (see Clause 28 and 35). By analogy with current registration rules in Kazakhstan, the new rules allocate a separate step for approval of the labelling of a medical device (see Clause 24): “the expert organization of the reference state within a period not exceeding 30 business days, confirms the correctness of translation of instructions for medical use and external package marking to the national language in accordance with the requirements of the Member States.”


  1. Pre-registration meetings and consultations


Formal pre-registration consultations are an interesting and long-debated innovation. Clause six of the draft of Eurasian registration rules establishes the possibility of prior consultation from the expert organization “on all issues of expertise and registration.” In its conferences and seminars Russian medical device regulator Roszdravnadzor talked in length about this possibility and the lack of legal mechanisms for its implementation. It should be remembered that today any consultations in the framework of the medical device registration procedure or any contact between an applicant and expert organization are officially prohibited in Russia.


  1. Lead-time for registration

The draft of new Eurasian medical device registration rules introduces the following timeframes for the main steps of medical device registration procedure:
• Five business days for formal checking of the registration dossier
• Three days to initiate registration procedure
• 60 business days for the expertise for registration procedure
• 30 business days for expertise for amendment procedure
• 90 business days for the organization of inspections of manufacturing site
• 30 business days to confirm the accuracy of the translation of instructions and markings
• 15 business days for the procedure of acceptance in selected countries of the EEU

The new rules also set out the following timeframes to provide additional materials on additional regulator`s request:

  • 30 business days after the formal cheek of the dossier (step before expertise)
    • 60 business days to the stage of expertise

I would like to remind you that the document published by the Eurasian Economic Commission currently has the status of a draft in the stage of public discussions. New medical device registration rules are expected to come into force across EEU since January 2016.


Disclaimer: Please note that this review is my professional analysis. It is neither an official report, nor official position of any organization or regulatory body.

9 thoughts on “Review of new Eurasian Economic Union Medical Device Approval Process.

  1. Pingback: Three Things You Should Know about Medical Device Regulations in Russia and CIS, July 2015 | Medical Device Regulations in Russia and CIS

  2. Dear Mr Stepanov,
    It is mentionned that “current (local) registration certificates of medical devices will be valid until 31 December 2021 at the latest.”. What should the manufacturer do to abtain a EEC registration certificate for an already registered product before 2016? Will it be just an administrative procedure to change the local registration certificate to a EEC one? Or will there be a kind of re-assessment of the product’s safety/effecacy/quality data to decide whether EEC common standards are filled? Or, the manufacturer has to pass a full EEC registration process for the registered medical device before 2016?
    Thank you very much in advance for your reply.
    Best regards,
    Meriem KONIEC

  3. Dear Meriem,

    Yes, it is correct: according to the clause # 13 of the Agreement of Common Rules and principles of circulation of medical devices, registration certificates for medical devices will be valid until 31 December 2021 at the latest. Form other hand there are still a lot of unclarity as far as a major part of second-level regulations are currently in phase of discussion.

    Based on documents that are available now, there is no information or reference about “simplified” or administrative procedure for this case. Moreover, based on OPINION of officials from Eurasian Commission declared on local regulatory conferences this year, it is more likely to be the full re-assement/re-registration of the product according to the new EEC rules.

    I am sorry that cannot provide you with more clear answer now, meanwhile I am monitoring this question and will publish all updates on it here.

    Kind regards,
    Alexey

    • Thank you very much Alex for this helpful and clear information!
      I would have two additional questions:
      – The regulation texts mention that the free circulation of MD will be applicable no later than 01/01/2016; will this be applicable for all Medical Devices registered inculuding those registered before 2016 (and until 2021) even if they are registered only in 1 or 2 countries, or does this concern only products registered via the EEC centralised procedure (in the reference Member state + local recognistion)? In other words, all products registered via national procedure will not freely circulate in the Union.
      -From 2016, will the EEC registration rules cover the national procédures? Or will the national procédures coexists until the concerned country align its regulation with the EEC one? If we are ineterestd in Russian Market only, can we register only in Russia with following russian regulation. If the “OPINION” you mention above is endorsed, of course, it will not make sense to register with local rules as re-registration will be needed within 5 years…
      I hope that my questions are clear,
      I thank you very much in advance for your support.
      Kindest regards,
      Meriem

  4. Hello again, Meriem!

    Free circulation between EEU countries is expected for medical devices approved under new EEU process only. E.g. if the device is approved for Russia now, it will remain approved for Russia (… till 2021), but for free circulation across Eurasian Union approval under the new procedure is a must.

    The clause #3 of the recently published draft of new EEU medical device registration rules says about “transitional period” when national and EEU registration systems will coexist. But for this draft it is still not clear, how long this transitional period will be.

    But even in the case of coexisting of two systems, if you submit under national process and get the national registration, you should consider the risk, that you will face with the need to re-register the product in 2021 under EEU process.

    Sorry again for possible confusion, but as I wrote previously there are now a lot of questions to be answered by Eurasian regulators within next three months.
    Hope it helps,

    Alexey

  5. Pingback: Russian Duma Ratified the Start of Functionning of Eurasian Medical Device Regulations | Medical Device Regulations in Russia and Eurasian Union

  6. Pingback: Three Things You Should Know about Medical Device Regulations in Russia and Eurasian Union, July 2016 | Medical Device Regulations in Russia and Eurasian Union

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