All medical devices placed on the Russian market must be registered and compliant with laws and regulations of the Eurasian Economic Union (EAEU). Since the establishment of the EAEU in 2015 a new regional registration system for medical devices has come into force. The EAEU registration rules have been in full effect since the start of 2022 and cover five markets: Russia, Belarus, Armenia, Kazakhstan and Kyrgyzstan.
An application and a registration dossier are submitted to the competent authorities of one of the EAEU countries. This country is referred to as the reference country. After the registration process is completed, the mutual recognition procedure is applied to register the medical device in the other four countries. The reference country will issue the registration certificate where all member states are included.
Foreign companies are required to have a local representative within the EAEU, that will act as liaison with the Competent Authorities of the Union. The Authorized Representative will manage your submissions and the registration of your medical devices. Authorized representative can also provide the post-market surveillance procedures in the EAEU.
The EAEU medical device classification is rule-based and, in general, resembles the European Union classification, but it differs from the EU regarding class I products. Besides, the EAEU maintains a large list of medical devices, and each product on this list has a corresponding code that determines its classification (Class 1, 2a, 2b or 3). Selecting the proper classification code is critical to ensuring a smooth registration process.
Technical testing in the Eurasian Economic Union is mandatory for all medical devices except IVD products. It is allowed to perform field-testing for capital equipment without importation, e.g., tomography unit. The testing must be performed in a testing laboratory accredited in the reference country. Biological testing is performed for all medical devices or parts of medical that come into contact with the patient except IVD products and biological evaluation in vivo and in vitro. Biological testing must be performed in special laboratories accredited in the reference country of the EAEU.
Manufacturers should implement and maintain the quality management system for medical device manufacturing. The Competent Authorities of the reference country will inspect the manufacturing site. The timelines for inspections are not included in the registration timelines but should not exceed 90 days.
There are numerous standards that should be taken into consideration while preparing a EAEU registration dossier for a medical device. The list of documents required for the regulatory submission is set forth in the medical device legislations of the Member States. When preparing for the application, you should include the post-market surveillance plan describing the data collection plan for safety and efficacy measures after potential marketing authorization. The risk management plan must be included in full. If your medical device contains a drug product, you must provide all the necessary data on drug safety. If your medical device is software, you must provide all the documents for software validation.
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