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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About holder and AR
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In one of the previous articles we discussed necessary symbols, that must contain label of medical devices for state registration in Russia. Today we present symbols, that must contain label of active medical devices. They are presented in the Table 1. Table 1 – Necessary symbols Power source parameters 1. Power (I or P) Consuming current or power GOST R
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Today we speak about some easy but necessary rules in Russia – labeling, marking of medical devices must comply with in order to medical device could be registered in Russian Federation. Should be noticed, that all the labeling rules (except the electrotechnical symbols) are regulated by 3 standards: GOST R 50444, GOST R ISO 15223 and GOST 14192. The last
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In one of previous articles we discuss quantity of medical device samples for toxicological testing (biocompatibility trials). Current article is about necessary number of stomatology (dental) material samples for toxicological testing. The standard regulated this quantity in Russia is GOST 31576. And its actual version is GOST 31576-2012. The 3rd section of these standards contain the table, regulating the necessary number
Read moreSeminar for Korean manufacturers contains information about: how to be prepared for technical and toxicological trials (preclinical trials) during Russian registration? what is main feature? does Russian Government have list of applied standards for medical devices nowadays? how to provide trials of IVD? How registration process is provided and what is the place of trials in this process.
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Meet us at MEDICA 2017! Our booth number is 12e47
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After one month there is still no any official information about consulting services for medical device registration process from expert center sides, neither about process nor about cost and procedure. Short information by link – Order of the Federal Service on Surveillance in Healthcare dated 19.07.2017 No 6478 (started 10.09.2017 – about consultancy in expert centers)
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On 22 September 2017 Order No. 403n of the Ministry of Health of Russia dated 11 July 2017 came into effect in the territory of the Russian Federation Order No. 403n of the Ministry of Health of Russia “On approval of the rules for dispensing medicinal products for medical use, including immunobiological medicinal products by pharmacy organizations, individual entrepreneurs licensed
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Pharmaceutical benefits under the state social assistance program. Overall, the current situation with the medicine supply as part of the state social assistance program can be characterized as stable. According to health authorities of constituent entities of the Russian Federation, as of 01.07.2017 the medicine shelf inventory capacity funded from the Federal budget resources amounted to 15.9 billion rubles, which
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