There is a standard GOST 15150 in Russian Federation, which regulates climatic conditions of manufactured devices. It contains normative values of ambient temperatures for different modifications of devices for different climatic areas. According to GOST R 50444 medical devices must comply with requirements of one of these climatic conditions: УХЛ4.2 (English abbreviation see in table below), У1, У1.1, У2, У3,
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In connection with the recent tragic events attributed to plastic surgery, the Ministry of Healthcare of the Russian Federation has amended the requirements for the provision of medical assistance in the field of “plastic surgery.” On July 3, 2018, Order No. 298 N dated May 31, 2018 On Approval of the Procedure for the Provision of Medical Assistance in the
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Federal Law No. 140-FZ dated June 04, 2018 On Amendments to the Federal Law On the Circulation of Medicinal Products entering into force on June 15, 2018 has been designed to amend the procedure for the submission of documents for the purpose of the state registration of medicinal products, confirmation of the state registration, and introduction of amendments into
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GOST R 50444-92 is the most critical standard for medical devices in Russian regulation. The most critical points are: it is most usable standard despite of scope of this standard, by fact it is applied for all medical devices except of X-Rays, eyeglass optics and eye protection devices, this standard is quiet old and contains special requirements for medical device
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After receiving information about the death of the woman after planned plastic breast surgery in the OOO Elit Clinic company facility, the local office of Roszdravnadzor in Moscow and Moscow Oblast conducted an unscheduled audit of the aforesaid medical facility. During the audit visit, multiple gross violations of the applicable legislation were discovered. In particular, two plastic surgeons (one of
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The state marketing authorisation of medical devices (medical device registration process) in the Russian Federation is carried out in accordance with the Rules of State Marketing Authorisation of medical devices, as approved by Order of the Government No. 1416 of the Russian Federation dated 27 December 2012 (hereinafter “the Rules”). The procedure for the state marketing authorisation of medical devices
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Amendments for Order of Russian Government 1416 were done – and this 4th issue is the most significant from 2013 year. Main ideas: IVD registration uses fast track for 1 risk class devices Government could changes classification rules (4n code) – and in this case code will be changed automatically by informing holder Permission of samples import – as a
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The Federal Service for Surveillance in Healthcare informs about the adoption of the decree of the Government of the Russian Federation dated 31.05.2018 № 633 “On amendments to the Rules of State registration of medical devices”. The Government decree amended the Rules of State registration of medical devices № 1416 which were approved by the Government of the Russian Federation
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Labeling of accumulators as a part of medical devices is required – full information in our new technical regulation issue.
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Main information you should know about biomedical cell product in our great update: what is biomedical cell product by law? name of biomedical cell product – how to combine it how to store biomedical cell product (main questions from people who couldn’t understand how this “product” look like)? international regulation safety monitoring – what is the role of manufacturer and
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