Medical device registration under EAEU rules

Medical device registration

Stage I. Preparation of the List of Documents Required for Medical Device Registration

Stage II. Registration and Expert Review of the Medical Device

Registration under EAEU rules imposes stricter requirements on medical devices and registration dossier documents than registration under national (Russian) rules. Obtaining a registration certificate under EAEU rules is a significant competitive advantage in the medical device market. The specialists at Rezultat-Audit are ready to provide professional assistance in developing, revising and preparing all the documents required for the registration dossier, as well as in supporting the registration process with the competent authorities.

Determining the List of Documents Required for Registration

The applicant submits the following documents to the competent authority of the reference state:

Proof of Safety and Efficacy

IMPORTANT! Fees for the expert review and registration of the medical device in the recognition states are paid after the reference state makes a positive decision on registration. The amount and procedure for paying the fees are determined by the legislation of the member states.

IMPORTANT! Production inspection is mandatory for sterile devices of risk classes 2a and 2b and for devices of risk class 3. For devices of risk class 1 and non-sterile devices of risk class 2a, the inspection may be carried out voluntarily.

Medical devices intended for circulation within the Eurasian Economic Union are registered in accordance with the Rules for Registration and Expert Review of the Safety, Quality and Efficacy of Medical Devices (EEC Council Decision No. 46 of February 12, 2016).

The list of documents required for the registration dossier depends on the potential risk class of the medical device. Depending on the degree of potential risk of use, medical devices are divided into 4 classes in accordance with the Rules for Classification of Medical Devices Depending on the Potential Risk of Use (EEC Board Decision No. 173 of December 22, 2015).

an application for expert review and registration of the medical device;
the registration dossier;
copies of documents confirming payment for the expert review and registration of the medical device in the reference state.

To confirm compliance with the general requirements for the safety and efficacy of medical devices and the requirements for their labeling and operational documentation (EEC Council Decision No. 27 of June 12, 2016), the applicant conducts the following types of tests while preparing the registration dossier documents:
technical tests in accordance with the Rules for Technical Testing of Medical Devices (EEC Council Decision No. 28 of February 12, 2016);
IMPORTANT! Technical tests are not required for in vitro diagnostic medical devices (reagents, reagent kits).
tests (studies) to evaluate the biological effects of a medical device in accordance with the Rules for Conducting Studies (Tests) to Evaluate the Biological Effects of Medical Devices (EEC Council Decision No. 38 of May 16, 2016);
tests for type approval of measuring instruments for medical devices classified as measuring instruments in accordance with the List of Types of Medical Devices Classified as Measuring Instruments upon Registration (EEC Council Decision No. 42 of February 12, 2016);
clinical trials (studies) in accordance with the Rules for Conducting Clinical Trials (Studies) of Medical Devices (EEC Council Decision No. 29 of February 12, 2016).
IMPORTANT! These types of tests must be conducted at institutions and organizations chosen by the applicant that are included in the unified register of authorized organizations entitled to conduct studies (tests) of medical devices for the purpose of their registration.

A new element of medical device registration under EAEU rules, compared with national rules, is the inspection of production. The competent authority (expert organization) of the reference state, or an organization designated by it (expert organization), inspects the production of medical devices in accordance with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use (EEC Council Decision No. 106 of November 10, 2017).

If manufacturers of medical devices of potential risk class 1 and non-sterile medical devices of potential risk class 2a have undergone an assessment of the medical device quality management system that covered design and development processes, then, during the validity period of the conclusion in the production inspection report, changes to the registration dossier of these medical devices are made by notification, without an expert review of safety, quality and efficacy.

A medical device that has passed the registration procedure established within the Union is labeled with a special mark of circulation of medical devices on the market of the Eurasian Economic Union in accordance with EEC Council Decision No. 26 of February 12, 2016.

Registration certificates issued under the EAEU registration procedure are valid indefinitely.

The registration process takes from 6 to 15 months.

At the applicant's choice, a medical device may be registered in one or several EAEU member states. The EAEU currently includes the following member states: the Russian Federation, the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan and the Kyrgyz Republic.

IMPORTANT! A device cannot be registered in the reference state alone. At least one recognition state must be selected for registration. The applicant may be a manufacturer that is a resident of an EAEU member state, or its authorized representative, who must also be a resident of an EAEU member state.

Our company offers dossier submission services and arranges payment of state fees when the Russian Federation, the Republic of Belarus or the Republic of Kazakhstan is chosen as the reference state.

IMPORTANT! When registering in several EAEU member states, a single authorized representative is appointed for all countries.

You can view and download the legislation governing registration rules in EAEU member states in the "Regulatory documents" section.

Companies

Services for obtaining medical device Registration Certificates and preparing medical device documentation. We work in accordance with EAEU rules and Roszdravnadzor requirements.

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