
Check-in the classification of medical devices
Classification marks the initial phase of the registration process. The pricing and timeline of registration projects depend on classification matters. Determining how the product list and composition will be presented in the final document, the number of required registration certificates, and the impact of classification results on the registration process — all these aspects should be addressed prior to commencing the market access procedure.
National regulation in Russia for medical devices encompasses 3 primary classification issues, applicable to all medical devices and IVDs:
1 - Nomenclature code (as per the Order of the Russian Government 4n) - medical device, medical software, and IVD classification rules based on the intended use of the product, its sterility, single or multiple use regulations, and healthcare group.
Generally, products under different codes cannot be combined into a single registration certificate.
2 - Risk class classification - determined by the potential risk of product use for patients. It comprises 4 options: 1st, 2a, 2b, and 3rd risk class, ranging from lowest to highest. The market access process may depend on this classification type, determining factors such as whether factory inspection for QMS is required, as well as post-market surveillance procedures.
There are no special classification options for measuring function medical devices and IVDs.
3 - OKPD2 - a general classification rule for any product in Russia, influencing VAT rates and sales issues.
All three classification items form part of the registration dossier and registration certificate, differing from classifications abroad.
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Medical device registration in Russia
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Registration of In Vitro medical devices in Russia
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Fast-track registration of medical devices
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552 - Decree of the Government of the Russian Federation…
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Expedited Registration - Regulation 299
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Government Decree 430 - abbreviated diagram
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Obtaining a declaration of conformity to GOST R for…
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Obtaining a declaration of conformity with the CU TR…