On 31 December 2019, the Russian healthcare regulator Roszdravnadzor announced first medical device approved under the Eurasian medical device regulations First registration certificate was issued for 2A class neonatal phototherapy lamp manufactured in Russia. The registration record has also appeared in the Eurasian database.
Dear colleagues,
This is my short selection of highlights on medical device regulation changes and trends across Russia and the Eurasian Union for the last month:
The Russian law No. 488 (link in Russian), enforced in December 2018, gave the Russian government the right to approve the lists of goods subject to mandatory labelling/marking with additional means of identification. The objective of this initiative is to counteract the turnover of counterfeit products on the market.
Before 2019, the product labelling/marking initiative worked in experimental mode involving fur products (since 2016), medical drugs (since February 2017), and alcohol and tobacco products (since 2018). This year, Russia is also planning to gradually introduce the requirement of mandatory identification labelling/marking on other types of goods.
On 7 February 2019, the Russian medical device regulator Roszdravnadzor reported that the draft document on mandatory marking of medical devices has been prepared by the regulator and will be published in the near future. According to the regulator, the new requirements have been prepared ‘in line with the latest international requirements and on analogy with UDI’ in order to ensure traceability and to adequately identify medical devices through their distribution and use in Russia.
On 14 February 2019, the decree No. 311 of the Government of Kyrgyzstan ‘On certain aspects related to the registration of medical devices’ (link in Russian) came into force and introduced multiple changes in the medical device regulation in the country.
Thus, new local medical device registration rules (link in Russian) were implemented. According to the new rules, the medical device registration process takes up to 90 days and consists of a two-step examination: analytical expertise (this step is not required for medical devices approved in the European Union, Australia, Canada, Japan and USA) and specialised expertise completed with manufacturing site inspections in some cases.
In addition to the new registration rules, the enforced decree No. 311 accepts that classification of medical devices, as well as technical, biocompatibility testing and clinical trials for local registration, are conducted according to enforced Eurasian regulations.
Kyrgyzstan is a full-fledged member of the Eurasian Economic Union since 2015.
The fifteenth meeting of the International Forum of Regulators of Medical Devices (IMDRF), chaired by the Russian Federation, will take place on 18-21 March 2019 in Moscow for delegates from the medical devices manufacturing industry, research institutions, federal executive authorities, state institutions, foreign and international regulatory organisations. The open stakeholders forum will be held on 19 March 2019, with an agenda and registration details available on the IMDRF website and on the official web page of the event.
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At the beginning of August 2017 Kyrgyz president signed the law “On Circulation of Medical Devices”. Draft of this law was published previously (link in Russian).
The published law introduced definition and classification of medical devices (harmonized with Eurasian regulations) and requirements for registration, clinical trials, manufacturing inspections and safety monitoring (post market requirements).
Since 2015, Kyrgyzstan is a member of Eurasian Economic Union, but until today country didn’t have dedicated medical device regulations.
Medical Device Regulations in Russia and Eurasian Union 