Accelerated registration of medical devices is carried out in accordance with Government Decree of the Russian Federation No. 552. The procedure is particularly attractive for low-risk class devices (1 and 2a), non-sterile ones — in this case, it is possible to obtain a registration certificate in the shortest possible time, up to 2 months, without conducting tests.
For high-risk class devices, accelerated registration loses its appeal, as it requires the creation of a full set of documentation and conducting tests similar to the standard procedure.
It should be noted that the registration certificate issued under Decree No. 552 is time-limited. To extend it and make it indefinite, it will be necessary to undergo a full confirmation procedure with new tests.
A major advantage of the procedure is that obtaining a temporary registration certificate under 552 does not require inspection of production sites.
Stages of our work in accelerated registration of medical devices:
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Preparation of technical and operational documentation — formation of the registration dossier in accordance with the requirements of Decree No. 552.
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Checking the device for compliance with the list under Decree 552 — confirmation of eligibility for accelerated registration.
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Conducting the necessary tests. Tests are carried out only when necessary (high risk class).
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Electronic submission of the dossier and interaction with registration authorities — making adjustments based on requests.
The process is applicable only to medical devices included in the approved list under Decree No. 552.
In our portfolio — more than 50 temporary registration certificates obtained through the accelerated procedure.