
552 - Decree of the Government of the Russian Federation 552 (accelerated registration of medical devices)
Order of Russian Government 552 is one of the measures accelerating the registration of medical devices in Russia. This document was adopted in April 2022 to prevent a shortage of medical devices in Russia.
The Order includes two main subparagraphs:
- Simplification of the existing primary registration scheme (Order of Russian Government 1416) for all types of medical devices.
- Introduction of an even more quick registration scheme for medical devices and in vitro diagnostic devices from the list in the appendix.
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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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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…