Category Archives: MD regulation

Fast track registration for products from special list

Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list of products: medical devices with 1 risk class are included in this list (for example, gloves), “fast track” includes initial submission with very limited amount of documents – with providing main dossier after registration certificate

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Medical devices that include components of animal origin

 An extensive group of medical devices (MDs) includes completely different products that may include different components. In the section devoted to MD, articles about drugs as part of MD have been published more than once (here and here). However, in addition to medicinal substances, various components of animal origin can be included in MD. Product overview Among the MD, which

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Import of medical device samples for the registration on the territory of Russian Federation

Order № 633 “On the introduction of amendments to the Rules of state registration of medical devices” came into force in June 2018. This normative document introduced the amendments to the range of important processes, including the confirmation of sample import. According to the Order, from now on the registration dossier should contain the hard copy of the sample import

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Climatic zone classification for medical devices

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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Medical device classification in GOST R 50444-92

GOST R 50444-92 (equivalent to GOST 20790-93) is an important standard for many types of medical devices in Russia, and is particularly important for their marketing authorization procedure; however it has several specific features to be mentioned: Despite its vaguely described scope (which is as medical devices, medical apparatus, medical equipment and sets of medical equipment, except X-ray medical equipment

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Changing in Regulation for medical devices – the biggest from 2013

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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Medical device labeling

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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