
Fast-track registration of medical devices
Apart from the general registration scheme within the Russian medical device market, there are several fast-track regulatory options available.
Each can be applied to different products and situations:
- Order of Russian Government 430 - offers a time-limited registration certificate option, initially designed for pandemic products required during COVID-19. It can be utilised for products listed in the appendix to the Order, with specific requirements for technical dossier and sample importation.
- Order of Russian Government 299 - provides a registration certificate without an expiry date, primarily for low-risk class products.
- Order of Russian Government 552 - offers a time-limited registration certificate, applicable to products listed in a special appendix to the Order.
Let's delve into each process in detail.
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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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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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Check-in the classification of medical devices
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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…