Welcome to my monthly review of the most important updates in regulations of medical devices in Russia and the Eurasian countries.
In addition to the significant and long-awaited milestone announcement made in early January 2020 on the first medical device approved under the Eurasian medical device regulations, over the last month, there were further updates in local regulation systems, which are discussed below:
1. Criteria for Unplanned Inspections by Russian Competent Authorities
In continuation development of regulations on medical device control procedures in Russia and following the resolution #1433 (link in Russian) enforced in November 2019, on 17 January 2020, the Russian Ministry of Health published the draft regulation ‘on approval of risk indicators of violation of mandatory requirements used as the basis for unscheduled inspections <…> for circulation of medical devices’ (link to the draft in Russian).
The published document provides ten criteria that may be considered by the regulator to be the reasons for initiating unplanned inspections of manufacturers of medical devices and other organisations involved in medical device turnover. Most of the criteria are centred on situations where the regulator receives information regarding certain issues such as violations of current regulation (i.e. about the circulation of falsified, poor quality, or unregistered medical devices), safety concerns with respect to a medical device discovered in the international databases that was not reported in adherence to the Russian regulation, off-label use of a medical device, and such other violations.
According to the information in the regulation database, the draft is currently open for public discussion until 06 February 2020.
However, let me remind you that according to Resolution #970 on state control of medical devices, the Russian healthcare regulator Roszdravnadzor performs planned and unplanned inspections of medical device manufacturers. The list of organisations for planned inspections in 2020 was published by Roszdravnadzor at the beginning of 2020.
2. New Process for Importation of Samples for Registration in Russia
On 28 January 2020, the Russian Ministry of Health published a draft regulation (link in Russian) on the amendment of the procedure for importing samples of medical devices to Russia for registration and registration renewals. It should be noted that this process is currently regulated by the Order #7N.
According to the published document, samples for registration may be imported into Russia according to the special procedure single-use importation permit by the manufacturer of the product, or its authorised representative, registered in Russia as a legal entity. The number of samples allowed for importation is calculated by employing recommendations from laboratories conducting pre-registration testing. The sample importation permit is granted by the competent authority based on the application within five business days. According to the draft, this regulation is not applicable to software.
The draft is currently open for public discussion until 17 February 2020.
3. Belarus is Discussing Amendments in Price Regulations for Medical Devices
At the beginning of January 2020, the Belorussian Ministry of Antimonopoly Regulation and Trade published a draft order ‘on prices of medicines, medical devices, and its spare parts’. According to the published document, the Belarusian government is implementing the price regulation for certain groups of medical devices and their spare parts, which are included in the special lists approved by the Ministry of Health of Belarus. The document also established the trade margins, from 10 per cent to 40 per cent, depending on manufacturers’ selling prices or estimated prices.
Thank you for following my blog intended to provide up-to-date information on medical device regulations in the region. Your feedback, questions, and comments regarding my updates are always welcome.
Pingback: Three Things You Should Know about Medical Device Regulations in Russia, May 2020 | Medical Device Regulations in Russia and Eurasian Union