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Effective from January 1, 2022, the registration process for medical devices in the Eurasian Economic Union (EAEU) follows specific guidelines and regulations. Registration can occur in a single member state or across multiple member states within the Union. The key regulation document for all member states is Decree No. 46 "On the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices" of Eurasian Economical Commission Council. The registration certificate serves as the official document acknowledging the registration of a medical device, while a special mark indicates compliance with the EAEU regulations for medical device circulation in the market.
The process comprises several stages described below.
1) First, the risk class and nomenclature of particular medical device should be determined, resulting in specific requirements to the registration dossier documents.
2) Completion of required technical and preclinical tests to ensure compliance with EAEU safety and effectiveness requirements. An applicant should perform the following studies, depending on the risk class and type of particular medical device:
➢ Technical testing (except for medical devices for in vitro diagnostic tests). Average estimated timeline is 30-50 business days, it is not officially regulated.
➢ Preclinical testing (assessment of biological effects) for medical products that come into contact with the human body. The official timeline, regulated by Eurasian Economic Commission Council, Decree No. 38, is 10 calendar days with potential extension for extra 30 business days.
* Electromagnetic compatibility testing (electrical medical devices). Average estimated timeline is 30-50 business days, the timeline is not officially regulated.
* Testing for the approval of type of measuring instruments (for medical devices classified as measuring instruments). Average timeline is 3-4 months, it is not officially regulated.
3) Clinical evaluation stage become available after the completion of technical and preclinical tests, the requirements for that stage vary depending on type and risk class the medicinal product:
➢ Medical devices of risk classes 1 and 2a (non-implantable) that have registered analogs in EAEU countries require only clinical report on evidence of efficacy and safety, certified by corresponding healthcare facility. The approval process takes 1-3 months, the timeline is not officially regulated.
➢ Medical devices of risk classes 2b and 3, including implantable ones, as well as devices that do not have registered analogs in EAEU countries, require multicenter clinical trial including centers from at least one EAEU member state.
The clinical trial requires obtaining permission from the Ethics Committee and the authorized body of the EAEU member state. Total timeline estimate for that stage is 9-12 months.
➢ Products for in vitro diagnostics at this stage require only report(s) of clinical studies and clinical experience as well as literature review.
1) The applicant selects the reference state and recognition states, performs state duty payment in the reference state. The authorized body of this reference state, such as the Federal Service for Surveillance in Healthcare ("Roszdravnadzor")of the Russian Federation, performs the registration process. EAEU recognition states coordinate and provide their expert opinions.
After the submission of the dossier to the authorized body of the reference state, verification of the registration dossier (formal check) starts, that initial step of the registration is limited by 5 working days.
In case of discrepancies during the verification step, the authorized body issues request specifying them and the comments for their removal. The term to address the request is limited by 30 business days.
2) Assessment of the quality, safety, and efficacy of medical device. Inspection of manufacturing.
The maximum timeframe for expert evaluation of the quality, safety, and effectiveness of a medical device is 60 business days.
If the authorized body identifies any deficiencies during the expert evaluation of a medical device, the applicant will be notified and provided with details regarding the nature of the observations and the necessary corrective actions. The applicant should reply within 60 business days to resolve all identified issues.
3) During the expert evaluation process for medical devices of risk classes 2b and 3, as well as for sterile medical devices of risk class 2a, official manufacturing inspection will be performed to ensure compliance with the requirements for implementing, maintaining, and evaluating the quality management system according to Russian National Standard ("GOST") ISO 13485-2017.
The time limit for a manufacturing inspection is 90 business days (excluding from the overall timeframe for expert evaluation of the quality, safety, and effectiveness of a medical device).
4) Expert evaluation conclusion of the reference state.
Upon positive conclusion of the expert evaluation regarding the possibility of registration of the medical device in the reference state, the authorized body will inform the applicant about the requirement to submit copies of documents related to the payment of state fees in the recognition states.
5) Harmonization of the expert evaluation by the recognition states.
The authorized bodies of the recognition states are required to provide confirmation of agreement or disagreement with the expert evaluation to the authorized body of the reference state within 30 calendar days.
Non-approval of the expert evaluation by any of the recognizing states will result in the refusal to circulate the medical product within the territory of that state.
6) Decision for the registration of medical device in EAEU.
The decision on the registration of a medical device is issued by the authorized body of the reference state within 10 business days from the date of receipt of the expert evaluations by the recognition states. Issuance of the registration certificate takes extra 10 business days.
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