
Registration of In Vitro medical devices in Russia
Market access for IVD products within the general registration scheme for local Russian regulation mirrors that of medical devices.
However, the registration flow chart can vary significantly:
- For reagents/calibrators/control panels, each analyte and product typically requires separate registration. Otherwise, it can be sold out only as a kit (as stated in current classification and should be checked in advance)
- Trials specific often exclude biocompatibility trials and featuring a limited testing program (technical trials) shorter than clinical trials.
- No clinical trials as clinical evaluation as option. Each IVD products required clinical trials with human subject (human samples),
- Certain products, like blood tubes, centrifuges, and sample containers, are commonly categorized as IVD by default.
Registration process steps (presented on the chart) are the following:
The IVD manufacturer determines a final list of products for registration. This step is crucial for determining the number of required registration certificates based on classification of the type of medical device and the list of models (as set in the norms and rules for the classification of medical devices in Russia
The manufacturer appoints an Authorized Representative (AR) of the Manufacturer, though not necessary for Russian manufacturers. For manufacturers from Russia the AR is not required, since the manufacturer himself acts as AR. Shortly, at this stage it is determined who AR is and what powers they have
AR/Manufacturer prepares technical documentation for the selected products
AR imports product samples into Russian Federation, adhering to all necessary customs procedures
AR/Manufacturer submits an application for a inspection (if required by the type of product) and conducts this inspection
AR/Manufacturer contacts accredited laboratories for sample testing
Upon receiving test and clinical reports, along with necessary document legalization in the country of origin and notarization in the Russian Federation, a registration dossier is prepared
The AR submits the dossier to the Federal Service Roszdravnadzor and receives an acceptance registration case number
Roszdravnadzor reviews the case. Firstly, an expert within the department reviews the case for document completeness (e.g. not attached photographs or some necessary reports). In case some documents are missing, or there are comments on them, the expert requests additional information from the AR/Manufacturer. All requested documents should be provided within a 30-day period (calendar days).
The case is then forwarded to expert centers for technical and clinical regulatory evaluation, with a 50-day period for responding to queries. There are 2 expert centers - both subordinate structures of Roszdravnadzor - VNIIIMT and NQI (or NIK) (see more information about expert centers). They check the completeness of the information provided and the tests/studies conducted in order to verify the quality, effectiveness and safety of the medical device. If questions arise during the review process, the experts request information from manufacturer/AR.
If the previous steps are completed successfully, Roszdravnadzor issues an order to register the medical device or IVD product, as well as a Registration Certificate (RC) on paper. It is extremely important to pay attention to the original RC – original paper is necessary for making changes to the RC, to the registration dossier.
Our company offers comprehensive services for obtaining a registration certificate for IVDs:
- We examine a classifier and alert to risks during the registration process
- We assume the role of an Authorized Representative of the manufacturer
- We guide the process and offer assistance throughout the entirety of the project
- We oversee the project from inception to completion and in stages
- We handle registrations at various stages, including requests and following refusals
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Medical device registration in Russia
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Fast-track registration of medical devices
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552 - Decree of the Government of the Russian Federation…
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Expedited Registration - Regulation 299
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Government Decree 430 - abbreviated diagram
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Check-in the classification of medical devices
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Obtaining a declaration of conformity to GOST R for…
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Obtaining a declaration of conformity with the CU TR…