Registration of medical devices under the EAEU regulations

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Registration of medical devices

Registration of medical devices following regulations of the Eurasian Economic Union (EAEU) is mandatory for companies involved in the manufacture and marketing of medical devices. Safety of medical devices is ensured by additional testing undertaken in the course of registration with the EAEU. Experts test them for quality and compliance with applicable regulations and standards. No medical device is permitted to be marketed, purchased or operated freely without it being compliant with the approved regulation.

The circulation of medical devices is controlled in accordance with the Treaty on the Eurasian Economic Union dated May 29, 2014, Agreement on Common Principles and Rules of Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014, other international treaties that are governed by EAEU law, decisions of the Commission, and the legislation of the Member States. In the EAEU, medical devices are registered in accordance with regulations for documentation and assessment of safety, quality and successful operation of equipment. Applicable regulations were adopted by Resolution No. 46 of the Council of the Eurasian Economic Commission dated February 12, 2016.

Medical devices subject to mandatory registration

According to Decree No. 46 of the EEC Council dated February 12, 2016, para. 1 and 4 of Article 38 of the Federal Law “On the Fundamentals of Public Health”, and Decree No. 1416 of the Government dated December 27, 2012, the list of devices subject to public registration includes the following:

  • Any tools, apparatus, devices, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes, whether separately or in combination with each other, or in combination with accessories necessary for the use of products for their intended purpose;
  • Medical devices for assessment of human health (in vitro).

Problems you may encounter when obtaining registration on your own and how we can help

Registration of medical devices and cooperating with government authorities may not lead to the desired goal if done on one’s own. The following are common mistakes made by manufacturers when applying to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) on their own:

  • A registration dossier is completed incorrectly
  • A required package of documents for submission to Roszdravnadzor is incomplete
  • Information in an Application for Registration or other documents is incorrect
  • Some of the laboratory tests of medical devices required by the EAEU regulations are missing
  • The deadline for filing has been missed.

Registration of medical devices under the EAEU regulations is a complex task that requires a clear understanding of applicable regulations and experience in laboratory testing and completing the related documentation. Since medical devices affect patients’ health, they must be checked according to applicable rules, and the relevant powers should be vested in professionals. MEDALIS LLC employs a team of highly skilled professionals with years’ worth of experience. Our team members are familiar with all ins and outs of the current legislation, and willing to provide you with comprehensive support in registration of medical devices under the EAEU regulations. We guarantee that work will be completed to the highest standard, the deadlines will be met, and the process will be monitored from start to finish. We are continuously track any revisions in the legislation, which enables us to achieve top performance and prompt completion of our assignments.

Stages of registration of medical devices in the EAEU

Starting from January 1, 2022, Russia and other Member States of the EAEU will apply common standards to the registration and certification of devices across all Member States. The registration of medical devices is governed by Resolution No. 46 dated February 12, 2016. According to these amendments, Roszdravnadzor recommends that the following registration procedure be followed:

  • Analysis of the medical device involved. Identifying the risk class and nomenclature type of the medical device. Compiling a registration dossier.

  • Laboratory testing of medical devices (technical testing, toxicity testing, clinical trials and electromagnetic compatibility (EMC) testing (for electrical medical devices only)) to confirm the product’s quality and prepare a documentation package under the EAEU Agreement; the registration dossier is to be attached.

  • Selecting a reference Member State where an Application for registration of medical devices will be filed and an EAEU Member State where the subject medical equipment is intended to be marketed after being registered in the EAEU

  • Filing an Application for Registration with the Registration Authority (for example, with Roszdravnadzor in case of the Russian Federation). The agency’s officers will then verify the data provided.

  • Assessment of efficacy, safety and quality of the medical device.

  • Inspection of medical devices. Specialists will check the equipment according to engineering requirements and other parameters in accordance with the EAEU regulations.

  • Registration of the medical devices checked. If the state agency reveals no violations, a Registration Certificate for the medical device is issued. Information about the device is entered into the Unified Register of Equipment.

Special considerations on the transition between national registration rules to the EAEU registration rules

In pursuance with Resolution No. 46 of the EEC Council dated February 12, 2019 and Order No. 28 of the EEC Board dated March 9, 2021 “On Draft Order of the Council of the Eurasian Economic Commission “On Draft Protocol to Amend the Agreement on Common Principles and Rules of Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014”, before December 31, 2021, an application for examination or registration of a medical device could have been submitted in the manner prescribed by the laws of a Member State. The term of the certification varies based on the country where the medical device is registered.

After December 31, 2021, registration certificates received as part of the registration process under the national regulations of Member States will remain valid until their expiration dates as follows:

  • For the Russian Federation: for an indefinite period of time.
  • For the Republic of Kazakhstan: 5 years.
  • For the Kyrgyz Republic: for an indefinite period of time.
  • For the Republic of Belarus: 5 years.
  • For the Republic of Armenia, no national registration procedure is available.

Any medical device that has been registered according to the regulations of a national legislation system of the host State (except devices that have been registered for an indefinite period and have a certifying document) must be reregistered according to the EAEU regulations. In this case, the registration procedure is to be completed again in the usual manner. However, if a valid Registration Certificate obtained under the national system of a Member State is available, it will be easier to prove the safety, efficacy and quality of a medical device to be registered.

The registered documentation for a medical device may be amended if it was registered under the approved legislation of the host State. To launch the procedure, an application should be filed before December 31, 2026.26.

How long it takes to obtain registration of a medical device

How long it takes to get a medical device registered in the EAEU depends on the class of, and risk associated with, the device to be registered, number of its versions, and other features of the product. Unlike the registration process under the national system, registration of medical devices in the EAEU is a more complex procedure, involving more rigorous checks of the product by an expert institution and a more complex testing procedure. In this connection, the average duration of the registration process under the EAEU regulations is longer.

EAEU Russian Federation
Registration Certificate validity period For an indefinite period of time. Until 2026
Territories where Registration Certificates are recognized In all the countries of recognition to be selected by the applicant. At least one country. For example, Russia + Kazakhstan (the country of recognition). Within Russia
Manufacturing inspection Classes 1 and 2a (non-sterile): voluntary; Class 2a (sterile) and Classes 2b and 3: compulsory./b > None
Expert Report approval With the member states concerned (Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia). None
State fees In Russia and countries of recognition, fees will be payable in the country of registration and in each of the countries of recognition specified by the applicant. В РФ

What the Applicant will obtain from registration of medical devices

The Customer will save their money and invaluable time and will receive a formal Registration Certificate as a result of our cooperation, thus becoming authorized to market their medical devices in the EAEU Member States. With us, you will be ahead of your competitors and will be able to get the most out of sales of your product.

Why choose us

  • We are accredited for testing medical devices under the EAEU regulations.
  • We charge no markup or hidden fees.
  • We offer a turnkey registration service, which includes technical tests, toxicity testing and clinical trials of medical devices
  • MEDALIS LLC is part of Eleсtrontest Group which has helped obtain more than 600 Registration Certificates for various medical devices

By hiring MEDALIS, you will obtain expert services with no agency fees, and consultancy support throughout the registration process for your medical device. Please contact us by phone at: +7 (495) 455-11-16 (ext. 206) or +7 (919) 777-93-36 to launch the process today.

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