Registration of medical devices under the EAEU procedure

Registration under the EAEU procedure allows you to obtain a single registration certificate recognized in the territory of all member states of the Union: the Russian Federation, the Republic of Belarus, the Republic of Kazakhstan, the Republic
of Armenia and the Kyrgyz Republic.

This opens up the possibility of simultaneously launching a product on the market
in several countries without having to go through separate national procedures.

The reference country is the country in which the registration dossier is submitted. In addition, at least one recognition country must be indicated, in which the certificate will also be valid.

Regulatory framework

Since 2017, the Eurasian Economic Union (EAEU) has been able to register medical devices in accordance with uniform regulations.

Registration under the EAEU rules requires a specific dossier structure, different from national requirements, as well as specific features in conducting
tests and preparing documentation.

The following questions require solutions:

The complexity of the process of registering medical devices under the law of the EAEU in comparison with national regimes for registering medical devices;

Ensuring stable information interaction in the field of circulation of medical devices within the EAEU (implementation of an integrated information system of the EAEU);

Insufficient level of trust in the recognition of expert reports on the effectiveness, quality and safety
of medical devices by the states
of recognition;

Our team is ready to assist you through all stages of registration in accordance with EAEU rules.

Key stages of work

The entire procedure is based on a clearly defined algorithm, taking into account the specific regulatory requirements of the EAEU. As part of our service, we will provide the following:

Product classification

We determine the product type code and its potential risk class. We prepare an application for registration in the reference state and the recognized states;

Preparation of documentation

We promptly develop a set of documents necessary for organizing and conducting tests;

Selection of test centers

We select accredited laboratories
and provide recommendations
on the timing and cost of services;

Tests support

We coordinate the entire process, ensure sample delivery to laboratories, review test reports, and, if necessary, coordinate and make adjustments
to documentation;

Production inspection
support*(if necessary)

We provide training and support for inspections by the authorized body;

Interaction with the regulator

We respond promptly to incoming requests and resolve any issues
that arise;

Submission to a government agency

We submit the dossier for verification
of the completeness and accuracy
of the information;

Formation of a dossier

We assemble a registration dossier
in accordance with EAEU requirements. The completed package is approved
by the authorized representative or manufacturer;

Product examination

We receive a conclusion on the product’s compliance with quality and safety requirements, and if there are any comments, we address them;

Final steps

We inform you of the need to pay for state examination and registration in the countries
of recognition, and we receive supporting documents;

Linguistic adaptation

We provide professional
translation of the required documentation into the official languages of the states
of recognition;

Completion of the procedure

We send the translated documents
to the Federal Service for Surveillance
in Healthcare (Roszdravnadzor)
for transfer to the authorized bodies
of the countries of recognition;

If necessary, we provide support in preparation
for inspection, including the development and implementation of a product quality management system in accordance with the requirements
of GOST ISO 13485.

Result

Upon completion of the procedure, we notify you that the product has been added to the Unified Register of Medical Devices. You will receive
the original registration certificate.

Once a registration certificate is issued, the product is legally permitted for sale in all EAEU countries.

However, the Manufacturer must also remember to comply with established labeling requirements and conduct post-registration monitoring to ensure proper quality and safety during use.

Need a consultation?

Request a free consultation on the registration procedure  and ask all your questions.

Reasons to choose our team:

Transparent planning

We develop a detailed
registration plan in
collaboration with the
manufacturer or authorized representative… More

Professional approach

Our staff includes experts with proven experience in the field of medical device registration;

Flexible cooperation
format

We provide both full turnkey support and individual stages
of the registration process;

Financial guarantees

In case of registration refusal due to our company’s fault, we will refund the payment for services;

Open pricing policy

We provide clear and transparent pricing.