Registration of medical devices within the Eurasian Economic Union is carried out in accordance with the Rules for the Registration and Expertise of Safety, Quality and Efficiency of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission dated 12.02.2016 No. 46.
The applicant for registration may be a manufacturer who is a resident of a member state of the Union, or its authorized representative, who must also be a resident of a member state of the Union, and registration of a medical device may be carried out in one or several member states of the Union at the applicant’s discretion.
The member states of the Eurasian Economic Union are the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic and the Russian Federation.
The document confirming the fact of registration of a medical device is a registration certificate, which is issued indefinitely and is valid within the Union.
State registration of medical devices in the EAEU countries consists of 2 stages:
- Laboratory testing (Technical testing, biological evaluation, testing for the purpose of type approval of measuring instruments, clinical testing (research)).
- Expertise and recognition of other countries. The dossier is submitted in XML format.
Technical testing of medical devices
in accordance with the Rules for conducting technical tests of medical devices (Decision of the EEC Council of 12.02.2016 No. 28)
Tests (research) to evaluate the biological effect of a medical device
in accordance with the Rules for conducting research (testing) for the purpose of assessing the biological effect of medical devices (Decision of the EEC Council of 16.05.2016 No. 38)
Testing of medical devices for the purpose of type approval of measuring instruments
in accordance with the national legislation of the Member States of the Union
Clinical trials (research) of medical devices
in accordance with the Rules for Conducting Clinical Trials (Research) of Medical Devices in Authorized Organizations Selected by the Applicant, or includes available clinical data in the registration dossier (Decision of the EEC Council dated 12.02.2016 No. 29)
Reference state
a member state of the Union whose authorized body (expert organization) carries out the procedure for coordinating the expert opinion of the reference state.
State of Recognition
a member state of the Union whose authorized body (expert organization) carries out the procedure for coordinating the expert opinion of the reference state.
Cost and prices for services of registration of medical devices in the Russian Federation, the Republic of Belarus and the Republic of Kazakhstan – the countries of the EAEU: Kyrgyzstan and Armenia
If you need to register medical devices according to the EAEU rules, we recommend that you contact professionals, as you may encounter a number of problems. Our company’s specialists have experience in successfully registering medical devices in Kazakhstan and in the EAEU countries. Our team has already registered more than 310 medicines/medical devices in six countries. We are ready to provide a free consultation on registering medical devices in Kazakhstan and the EAEU countries, including registering medical devices according to the EAEU Rules.
The main problems of self-registration of medical devices in the EAEU include:
- the opportunity to encounter a large amount of information
- the procedure for registering medical devices in the EAEU may take up to two years or more
- lack of communication knowledge in the country
- the possibility of encountering difficulties during the paperwork
The advantages of examination and registration of medical devices according to the rules and within the framework of the EAEU with the help of Blitz Medica specialists:
- The organization will take care of all issues related to the preparation of documentation.
- Saving time. At the same time, Blitz Medica specialists will try to register medical products in the Republic of Kazakhstan in the shortest possible time
- Qualified specialists understand different areas of activity. They are able to cope with a task of any complexity
- Professionals select an individual approach to each project
- The company guarantees confidentiality
Registration of medical products in Kazakhstan is carried out in several stages. The stages are attached below:
| 1 | Collection of documents | 30 calendar days |
| 2 | Determination of the risk class of use and nomenclature type | 1 working day |
| 3 | Determination Collection of evidence of safety and effectiveness | 210 calendar days |
| 4 | Conclusion of an agreement with the reference state | 3 working days |
| 5 | Payment for expert work | 3 working days |
| 6 | Conversion of the dossier into XML format | 5 working days |
| 7 | Provision of documents | 1 working day |
| 8 | Expert work | 120 calendar days |
| 9 | Payment of state fees | 15 working days |
| 10 | Coordination of the conclusion of recognition by states | 30 working days |
| 11 | Registration of the registration certificate | 10 working days |
