Order 299 from 18.03.2020

Order of Russian Government 299 came into effect in March 2020. Let's review the main features:

1.        It is only for Class 1 risk devices (i.e., it does not apply to the registration of coronary stents or X-ray machines).

2.        It allows to obtain a registration certificate (bringing the device to the Russian market) before conducting the full scope of local testing.

3.        The dossier submission is time-limited and consists of two stages: submission of administrative documents and submission of trial results.

4.        There is no choice of laboratories for preclinical testing: technical tests and biocompatibility trials studies can only be conducted at the FGBU "VNIIMT".

5.        There is no expire date for the registration certificate.