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.
stage 1
Legal manufacturer prepares legalized company documents and technical dossier
stage 2
Application, TF and IFU preparation by AR
stage 3
Submission to RZN (expert center)
stage 4
RZN issues registration certificate (with expiry date)
stage 5
AR applies for samples import permission to RZN and support customs clearance
stage 6
Preclinical trials: biocompatibility trials, technical trials, EMC etcetera
stage 7
Clinical trials
accepted
Conclusion
stage 9
RZN expert center review
stage 8
TF and IFU legalization by legal manufacturer
stage 10
RZN canceled registration certificates (with expiry date)
not accepted
