The Eurasian Regulations – Six Months Before the Start

30 August 2021

As it is known, the Agreement on Common Principles and Rules for the Circulation of Medical Devices in the Framework of the Eurasian Economic Union (EAEU) implies complete transition to registration of medical devices based on the new rules starting from 1 January 2022. Here we shall give a brief overview of the state of affairs six months before the new system comes into effect.

According to the information system data, the last three years saw 46 cases of filing registration applications in line with the new rules. As of early June 2021, the Unified Register of Medical Devices Registered in the Eurasian Economic Union contained only 5 entries of registered medical devices, all of them manufactured by companies located in the EAEU countries. Registration application processing took 87 to 363 days depending on the country.

Over 30 laboratories, located in Russia, Belarus, Kazakhstan, Kyrgyzstan and Armenia, are listed in the Unified Register of Institutions Authorized to Conduct Medical Devices Testing for The Purpose of Registration. Most of the labs on the list, which we were able to contact, stated their readiness either to conduct tests in compliance with the Eurasian standards or to begin necessary preparations for that.

Early this year we submitted a request with Roszdravnadzor (Federal Service for Surveillance in Healthcare) if it was necessary to obtain permission prior to importing a medical device. According to Roszdravnadzor’s response, the import procedure has not been set by any regulations in place.

The manufacturer’s quality management system audit is one of the key new features for the EAEU, which is also mandatory for class IIb and class III medical devices registration. It is worth reminding that Roszdravnadzor published information on the first manufacturing process inspection of compliance of implementation, maintenance and assessment of the medical devices quality management system in September 2020.

According to the response to our inquiry with Roszdravnadzor, FGBU National Institute for Quality of Roszdravnadzor (Federal State Budget Institution “National Institute for Quality” of the Federal Service for Surveillance in Healthcare) and FGBU VNIIIMT of Roszdravnadzor (Federal State Budget Institution “Russian Scientific and Research Institute for Medical Engineering” of the Federal Service for Surveillance in Healthcare) are authorized to perform inspections on behalf of Russia.

Mandatory multicenter clinical testing on humans for class IIb and class III medical devices and for implantable medical devices is one more new requirement. At the moment, according to Roszdravnadzor, 16 medical institutions are authorized to perform tests in line with the Eurasian system. It should be noted that the registration procedure under the Eurasian Economic Union regulations implies single-stage evaluation and requires filing clinical data as part of the registration dossier.

Raifarm team continues to closely follow the developments related to the Eurasian regulations of the medical devices circulation in order to implement the new rules in our work.