Medical Device Regulation in Russia & EAEU

On 25 September 2018, the “Medical Device Regulation in Russia & EAEU: Regulatory Landscape 2018” conference, organized by Raifarm, was held at the InterContinental hotel.

“Regulatory landscape” means the current situation in the field of circulation of medical devices with all of its regulatory irregularities - ups and downs.

The conference was organized for clients and partners of Raifarm. Certain issues were considered, starting with the principles of regulation of circulation of medical devices according to the national and Eurasian rules and ending with consideration of complicated cases of registration from the experience of Raifarm.

The following presentations were given at the conference:

1. Principles of regulation of circulation of medical devices, a short overview of the national registration system.

2. Problems with registration of medical devices in Russia: experience of 2016-2017.

3. Overview of the system of regulation of circulation of medical devices in the EAEU: expectations and reality.

4. Regulatory strategy of Raifarm in Russia and the EAEU.

Among some particular issues, the following was considered: the specifics of preparation of a registration dossier based on the national rules, the procedure for preparation of a technical file in compliance with the Russian requirements.

The specifics of conducting registration trials in accordance with the national and Eurasian requirements were separately discussed. This issue remains one of the most significant ones for all the foreign applicants for registration, since the Russian Federation continues to rely on the results of trials conducted according to the national rules, and these rules are not always clear and comprehensible.

Another important issue brought up in the course of the presentation on the registration problems in 2016-2017 is the registration of medical devices containing medicine. The requirements for the mandatory separate state registration of medicinal products and pharmaceutical substances included in a medical device resulted in the registration collapse and required a whole range of concerted actions on the part of the market participants to resolve the issue.

To sum it up, we would like to communicate the following - in our opinion, the companies, who count on entering the Russian and EAEU markets, do not have to wait for the EEAU registration rules to become effective, but it makes sense to prepare and submit the dossier according to the Russian national rules. The enactment date of the EEAU registration system has been multiple times re-scheduled; the law enforcement practice is still unavailable, and the submitted applications have been lying idle. However, it is more than likely that a law might be adopted allowing medical devices, having passed the national registration, However, it is more than likely that a law might be adopted allowing medical devices, having passed the national registration, to circulate on the territory of the country after the expiration of the period established by the EAEU legislation.

Our next regulatory conference will be dedicated to some certain aspects of registration of medical devices containing medicine, and namely, cosmetic fillers.

The next conference will be announced additionally.

Mikhail Vinogradov, Senior Manager Regulatory Affairs (Medical Devices).