Rules for registration of medical devices under the EAEU procedure

Key differences

This topic is the most frequently requested, along with national expertise (LCS-kz). The procedure for issuing registration certificates for medical devices within the EAEU is fundamentally different in approach. Firstly, it is a process carried out within the framework of five states, which in itself is more complicated than doing the same thing within the framework of the legislation of only one country. Secondly, there is a major difference from the Kazakhstani approach - laboratory tests come before expertise. That is, before we start the registration process itself, technical and biological tests must be carried out. And thirdly, - the rules for registration of medical devices under the general rules require the reference country to choose at least one side of recognition. Let us analyze each statement separately.

EEU Registration Certificate

There are common verification rules and a common registry certificate within the five states. However, obtaining such a certificate means that your national RI cannot be traded in parallel on the market. To start with, you choose one reference country, which will give the main opinion and up to 4 other recognition countries. If the reference country is Kazakhstan, then respectively Russia, Belarus, Kyrgyzstan and Armenia will recognize the opinion. The reference country makes a full examination of the submitted dossier, conducts a site inspection if necessary, requests the necessary additional materials and issues an opinion. After that, the stage of harmonization with other selected states begins. This procedure is called recognition and it takes place between the regulatory authorities that exchange data on your MI. After positive recognition, the reference body issues a general registration certificate for the medical product, which will specify the countries in which your product can be used.

Laboratory tests

Within the framework of national legislation, the analytical stage is carried out during the registration process. Here, the manufacturer has no choice, and testing takes place in the national laboratory, the last stage. According to the EAEU rules, products that have passed laboratory tests are allowed for examination. The manufacturer independently finds an accredited laboratory (or several laboratories) to conduct technical and biological tests. Most often these are two different laboratories, as they are subject to different standards of conformity. The most important requirement for these laboratories is that they must be accredited to conduct tests exactly within the framework of the EAEU registration. This is confirmed by a special sign on the protocols. Compilation of the program, review of materials and testing itself can take from half a year and more, depending on the complexity of MI or technology. Further, these reports are submitted to the dossier for examination. Selection of laboratories can be carried out according to a special register (LCS Blog).

States of recognition

If you do not need all five countries, you may not choose the four regions of recognition, but must choose at least one. These are the conditions for obtaining an RI. If you are only interested in the reference state, you can make a national registration, until the end of 2025. From 01.01.2026, all countries in the union will move to common rules, and national rules will not be available. Once the recognition procedure has passed, your product will be placed in the common register, where the recognizing states will be specified and the marking layouts and instructions will be displayed.

Other features

- All dossier materials are completed electronically, in XML format. The dossier can also be submitted remotely via the portal

- All state fees for examination fees are posted on the regulatory agency websites. Payments are made remotely

- Translations of dossier materials (partially) are made into the languages of the territories where the MI is registered

- In some cases, recognition by other countries may be denied. In this case, you will receive a registration certificate with only one country of application

- In case of testing, the contract with laboratories is concluded separately, according to the rules of the testing center itself. When submitting the dossier, in addition to the reports themselves, the approved programs must be submitted