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REGISTRATION
OF MEDICAL PRODUCTS IN THE EURASIAN ECONOMIC UNION

State registration of medical devices is a list of measures taken in order to obtain admission to the production, sale and use of medical devices on the territory of the EAEU.

In connection with the formation of a single market for medical devices in the EAEU from January 1, 2022, medical devices will be subject to registration only in accordance with the rules of the EAEU. This means that the circulation of medical devices on the EAEU market is possible only after passing the registration procedure in accordance with the unified rules of the EAEU.

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Medical devices registered according to national rules in a Union Member State can be applied before the expiration of the national registration certificate and only on the territory of the State of national registration. At the same time, until December 31, 2026, there is the possibility of re-registering medical devices and making changes to the registration dossier for medical devices with national registration.

Process of registration 

  • choice of reference state and states of recognition

  • collecting evidence of the safety and effectiveness of medical devices

  • formation of the registration dossier and its submission to the authorized body of the reference state

  • checking the completeness and reliability of documents and making a decision to start the registration and examination procedure

  • manufacturing site inspection

  • carrying out all necessary tests

  • coordination of an expert opinion with the recognition states

  • registration of medical devices and issuance of a Registration Certificate

  • adding information about registered products into the Register

Scope of provided services

  • selection of the optimal registration plan, based on the method of selling products, taking into account the specific of the products and current practice;

  • evaluation of the timing of state registration and the list of procedures based on product characteristics;

  • assistance in choosing a reference state of registration and countries of recognition, taking into account the analysis of existing risks;

  • collection and preparation of the registration dossier;

  • translation of the registration dossier into Russian according with the requirements of the legislation;

  • support of the registration process after submitting the registration dossier to the authorized body, interaction with expert institutions;

  • support of the process of carrying out technical, toxicological and other tests (in case of appointment);

  • support of the preparation procedure for the inspection control of the production site (I required);

  • accompaniment of clinical trials (if required);

  • receiving the expert opinion;

  • obtaining a properly executed Registration Certificate with preliminary control for errors, mistakes and other inaccuracies.

The procedure of registering medical devices under the EAEU rules is more complicated, laborious and time-consuming than registration under national rules. At the same time, the formation of a common market for medical products will allow interested parties to freely sell and use medical products throughout the EAEU based on the results of a single registration procedure without the need to undergo separate registrations in each Union Member State.

 

AVAKO specislists have a long-term experience in the regulatory field and have already registered dozens of medical devices in the EAEU countries. Our company will help you in the implementation of the registration procedure for medical devices in the EAEU.

Registration of medical devices intended for circulation on the territory of the Eurasian Economic Union is carried out in the manner prescribed by the Rules for registration and examination of the safety, quality and effectiveness of medical devices approved by the decision of the EEC COUNCIL No. 46 dated 12.02.16.

 

Registration of a medical device at the choice of the applicant can be carried out both in one and in several EAEU member states.

 

The document confirming the fact of registration of a medical device is a registration certificate, which is issued indefinitely and is valid within the EAEU.

 

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