
Expedited Registration - Regulation 299
Order of Russian Government 299 came into effect in March 2020. Let's review the main features:
- It is only for Class 1 risk devices (i.e., it does not apply to the registration of coronary stents or X-ray machines).
- It allows to obtain a registration certificate (bringing the device to the Russian market) before conducting the full scope of local testing.
- The dossier submission is time-limited and consists of two stages: submission of administrative documents and submission of trial results.
- There is no choice of laboratories for preclinical testing: technical tests and biocompatibility trials studies can only be conducted at the FGBU "VNIIMT".
- There is no expire date for the registration certificate.
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