Simplified registration of medical devices is carried out in accordance with Government Decree of the Russian Federation No. 552 and is particularly relevant for low-risk class devices (1 and 2a), non-sterile ones. For them, it is possible to complete the process within up to 2 months, as they do not require testing.
For high-risk class devices, simplified registration loses its meaning: the need to create a full package of documents and conduct all necessary tests, which essentially equates it to the standard procedure.
It is important to note that under the simplified procedure, a temporary registration certificate is issued; to make it indefinite, an additional procedure must be completed.
A significant advantage is that when obtaining a temporary registration certificate under Decree No. 552, inspection of production sites is not required.
Stages of our work in simplified 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 simplified registration.
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Conducting the necessary tests. Conducted only when necessary, depending on the 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.
We have successfully obtained over 50 temporary registration certificates under the simplified registration scheme.