In the territory of the Russian Federation, only medical devices that have been registered, received their registration certificate, and been included in the State Registry may be legally marketed. The government authority responsible for the state registration of medical devices is the Federal Service for Healthcare Oversight (‘Roszdravnadzor’).
The current system of medical product registration began in 2013, following the Government Decree No.1416 of December 27, 2012. The system represents a complex, multilevel bureaucratic regulatory system that must be navigated carefully and skillfully.
With the establishment of the Customs Union (CU) and, subsequently, the Eurasian Economic Union (EAEU), the single national registration system was replaced with a joint procedure for medical product registration. Formally, the common market of medical devices in the EAEU States (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan) was launched in May of 2017, but the final registration legislation (Requirements for Implementation, Maintenance and Evolution of Quality Management System for Medical Devices) was not approved until the spring of 2018.
Currently, two parallel systems of registration exist: the national system (valid until January 1, 2022) and the supranational EAEU system. It should be noted that the rules of the EAEU registration are more transparent – largely improving and optimizing the registration process. However, the submission of registration dossiers, according to the new rules, has not yet become routine.
It’s an intricate and perplexing situation, but Raifarm is here to help with the following:
- Consultation and guidance with registration dossier preparation and strategy for overall product submission (to Russian national system)
- Consultation and guidance for product registration in EAEU system
- Preparation of technical documentation (technical file) and operational documentation, in accordance with the requirements of the Decree No.11n dated January 19, 2017
- Preparation of normative documentation and adaptation of manufacturer’s documents in accordance with the Russian requirements
- Preparation of importation documentation for samples of devices
- Test laboratory selection and preparation of all necessary documents for investigators
- Organization and management clinical trials of product
- Respond to Roszdravnadzor administrators requests at all stages of the registration process
- Translation and verification of all necessary documents (and notarization, if necessary)