Registration of the medical devices within the framework of the Eurasian Economic Union
What does registration procedure for a medical device under the EAEU rules look like:
Our company offers services for the registration of medical devices under the rules of the Eurasian Economic Union (EAEU). Russia, along with the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, and the Kyrgyz Republic, is a part of the EAEU. The purpose of the union was to simplify the rules of economic interaction between countries, as a result of which unified safety and quality standards for different categories of products were established. This condition covers medical devices and their registration. The general procedure for cooperation between countries in this segment is governed by the provisions of the Treaty on the EAEU dated May 29, 2014. The rules of registration and examination of safety, quality and efficiency of medical devices are regulated by the EAEU Council Decision No. 46 dated 2016. Presently (prior December 31, 2021) registration of medical devices can be carried out both under national rules and the new rules of the Eurasian Economic Union. After December 31, 2021, all registration certificates shall be issued only under the EAEU procedure. Registration certificates of the new type are issued for indefinite period of time and open access to the markets of other countries that are members of the union, allowing operating within the integrated information system of the single market of medical devices of the EAEU. The registration procedure under the new rules is more complicated and imposes strict requirements on medical devices and relevant documentation. Registration under the new rules may take from 1 to 2 years, but the registration certificate issued under the new rules may become a great advantage over competitors on the medical device market.
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More details on the audit and registration procedures for medical devices, regulatory documents, as well as the list of documents required for registration of a medical device can be found on the official web-page of the EAEU
What does registration procedure for a medical device under the EEU rules look like:
Stage 1 – preparation of the registration docket documents
- Definition of the device risk class: according to the Decision of the Eurasian Economic Commission dated December 22, 2015 No. 173, medical devices are divided into 4 classes, depending on the potential risk of use. The contents of the registration docket depend on the risk class of the product.
- Determination of the list of required registration docket documents (depending on the type of in vitro/non-in vitro devices, risk class of the device)
- Evidence of the safety and efficiency of the device. General requirements for safety, efficiency, labeling and operational documentation are regulated by EAEU Council Decision No. 27 dated February 12, 2016. At this stage, all necessary types of tests are performed (technical, clinical, and laboratory tests, as well as tests performed to assess the biological effects of a medical device). The volume, timing and cost of tests are determined by the specifics of the product and are conducted in certain laboratories with the appropriate accreditation and experience.
Stage 2 – registration and evaluation of a medical device
- Verification by Roszdravnadzor of the completeness and accuracy of the documents submitted (application for expert evaluation and registration, registration docket, copies of documents on payment for expert evaluation and registration)
- Inspection of the production and technological process for the production of the medical device
- Evaluation of the medical device and issue of an expert’s report
- Approval of the expert’s report. The opinion is published on a special information network accessible to all member countries of the union. After the states have analyzed the expert conclusions, a decision is made on the possibility of registration
- Execution of a marketing authorization.