Welcome to my monthly review of the most important updates in medical device regulations in Russia and Eurasia:
- Strengthening of Import-Substitution Policy for Certain Medical Devices in Russia
On 28 August 2021, the Russian Ministry of Industry and Trade issued Resolution #1432 (link in Russian), which significantly strengthens restrictions on public procurements for a range of over 170 groups of electronic equipment, including more than 30 groups of medical devices manufactured by foreign companies.
The resolution introduced the so-called ‘second odd one out’ rule, which requires public customers procuring products listed in the resolution to reject bids from foreign manufacturers if there is already one (or more) bids for the supply of the same product manufactured in the Eurasian Union. For the medical devices listed in this document, this requirement will replace the similar ‘third odd one out’ rule, introduced by Resolution #102 in February 2015.
In addition, the new regulation requires public customers to obtain permission from the Ministry of Industry and Trade to purchase imported products on the new list.
Resolution #1432 will affect computer tomography, mammography and certain other X-ray machines, certain endoscopic equipment, individual glucometers and glucose analysers, heart rate monitors, ultrasound equipment, inhalation anaesthesia machines and ventilators and some other groups.
2. Russian Regulator Updated Requirements for Importation of Non-registered Medical Devices in Russia
On 9 August 2021, the Russian government issued Resolution #1321 (link in Russian), specifying requirements for importing non-registered medical devices into Russia and the Eurasian Union. These requirements will apply to custom-made medical devices intended for personal use, medical devices imported for research and scientific purposes, medical devices intended for medical assistance during international cultural and sporting events, trade exhibitions and other cases.
According to the published regulation, such imported devices must be reported to Roszdravnadzor via electronic system within three business days.
Regulations allow for the transportation, storage, installation, adjustment, use, operation, maintenance and repair of such non-registered devices, as well as their disposal, destruction and export from the country.
The new order will go into effect on 1 March 2022 and will be valid until 1 January 2027.
3. Updates on Development on Eurasian Medical Device Regulations
There have been several updates to Eurasian medical device regulations over the last month:
At the end of July 2021, the Russian government confirmed (link in Russian) amendments to the Eurasian agreement on common principles of circulation of medical devices regarding deadlines for the end of the transition period, as previously proposed:
-Submissions for registration and expertise of medical devices according to local rules (of the Eurasian member states) will be open until 31 December 2021.
-If submitted before 31 December 2021, the registration dossier will be reviewed according to the local registration rules of a member state.
-Medical devices approved under the local registration system in Eurasian member states may remain approved in this member state until the registration expires.
-Registration certificates for medical devices registered according to the local rules may be amended (under local rules) until 31 December 2026.
Meanwhile, there is a discussion in the Russian media about a petition from manufacturers and Russian distributors regarding the possibility of extending the submission deadline based on current national requirements.
On 6 August 2021, the Eurasian Commission published a draft amendment to Eurasian Decision #106 ‘On the requirements for the quality management system for medical devices manufacturers’ (link in Russian), suggesting several updates on the status of the inspection body that performs the audit inspection.
As of the end of August 2021, seven medical devices have been approved under Eurasian rules.