According to a Decree of the Government of the Russian Federation No. 894, dated 31 May, 2023, the Rules are set out for the labelling

From 03/01/2022, within the framework of Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 “On approval of the rules for state registration of medical
Read more »According to a Decree of the Government of the Russian Federation No. 894, dated 31 May, 2023, the Rules are set out for the labelling of certain types of medical
Read more »The PharmComm company, the owner of the exclusive rights to the Bezornil® trademark, found pages of sellers on marketplaces that were not related to this product in any way. The
Read more »In May 2023, a letter regarding the safety of proton pump inhibitor drugs containing omeprazole, pantoprazole, rabeprazole, lansoprazole, esomeprazole, dexlansoprazole as an active ingredient was published on the website of
Read more »At the end of May 2023, a letter from the Ministry of Health and the expert center of the Federal State Budgetary Institution ‘SCEEMP’ was published on the State Register
Read more »On May 2, 2023, the Ministry of Health of the Russian Federation approved the procedure for importing medical devices for the purposes of state registration. According to Order No. 201n,
Read more »Regarding the national registration of medical devices in the Russian Federation, it is often clarified – is registration required in the country of origin or is a CE certificate, declaration,
Read more »In April 2023, the Ministry of Health of the Russian Federation issued Order No. 95n, which simplifies the procedure for making some changes to the registration dossier for a medicinal
Read more »As part of the implementation of Decree of the Government of the Russian Federation No. 2026 dated November 24, 2021 “On unregistered medical devices for in vitro diagnostics”, Roszdravnadzor for
Read more »Rospotrebnadzor plans to amend the technical regulations of the Customs Union “On food safety” (TR CU 021/2011) and “On the safety of certain types of specialized food products, including dietary
Read more »According to a Decree of the Government of the Russian Federation No. 894, dated 31 May, 2023, the Rules are set out for the labelling
From 03/01/2022, within the framework of Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 “On approval of the rules
One of the articles in the US medical device registration section was devoted to the PMA (premarketing approval) procedure. As part of this procedure, a
In Russia, there is a risk of disappearance of tests for genetic breakdowns and oncological diseases. According to information from some laboratories, there is a
With reference to the current economic situation, in April two resolutions of the Council of the Eurasian Economic Commission were adopted, namely No. 46 dated
Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our
For the first time, the Federal Service for Surveillance in HealthCare is conducting remote inspection of medical device manufacturing located abroad. The FGBU VNIIIMT of
First registration certificate under EAEU regulation was issued in the end of December 2019: registration certificate is in action inside Russia and Kyrgyzstan, for medical
On 19 April 2019 the territorial body of the Federal Service for Supervision in Healthcare in Moscow and the Moscow region, together with law enforcement
As a result of control and supervisory measures the territorial body of the Federal Service for Supervision in Healthcare in the Orenburg region exposed the
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