
Amendments to registration certificate for medical devices
The registration certificate of Roszdravnadzor is an approval document required for the circulation and use of a medical device or in vitro diagnostic device in Russia within the framework of the national regulatory system.
Government Decree 1416 of December 27, 2013 (the current text of the Decree in English) is the main document on the procedure and rules for registration of medical devices on the territory of the Russian Federation. This document came into force in 2013 and has been updated a significant number of times since then (the most significant changes: acceleration of the registration procedure for products of the 1st risk class, software, inclusion of permission for medical device samples import in the registration dossier).
How the registration process for a medical device is conducted? We will tell you briefly:
The manufacturer of the medical device determines the final list of products for registration. This step is extremely important - depending on the type of medical device and the list of models, the number of registration certificates may vary. It depends on the classification (norms and rules for the classification of medical devices in Russia).
The manufacturer appoints an Authorized Representative of the Manufacturer (in short - AR, who is it and what powers does he have), for a manufacturer from Russia - the AR is not required, the manufacturer himself acts as AR).
AR/Manufacturer prepares technical documentation for the selected products.
AR imports samples of medical device into the territory of the Russian Federation, taking into account all necessary customs procedures.
AR/Manufacturer submits an application for a production inspection (if required by the type of product) and conducts this inspection.
AR/Manufacturer contacts accredited laboratories to test samples.
After receiving test reports, clinical reports and preparation of documents (including legalization of documents in the country of origin and notarization in the Russian Federation), a registration dossier is prepared.
AR submits the registration dossier to the Federal Service Roszdravnadzor (receives the acceptance registration case number).
Roszdravnadzor reviews the case - first, an expert within the department checks the completeness of the submitted documents (for example, if you forget to attach photographs or one of the necessary reports); if not all documents are submitted, or there are comments on them, the expert sends a request to the AR / manufacturer. In order to provide the requested documents, there is a period of 30 calendar days.
Next, the case is sent for consideration to an expert center - there are two of them, both subordinate structures of Roszdravnadzor, in short - VNIIIMT and NQI (or NIK) (more information about expert centers). There they are considered from the point of view of technical/clinical regulatory requirements - that is, 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 send a request to the manufacturer/AR. In order to eliminate of request, there is a period of 50 working days.
If the previous steps are completed successfully, Roszdravnadzor issues an order to register the medical device, as well as a Registration Certificate (in short - RC) on paper. It is extremely important to pay attention to the original RC – original paper is necessary to make changes to the RC, to the registration dossier.
Our company provides a full range of services for obtaining a registration certificate for medical devices:
- we check a classifier and warn about risks during the registration process
- we take a function of an Authorized Representative of the manufacturer
- we accompany the process and provide support throughout the entire duration of the project
- we manage the project both from start to finish and in parts
- we take cases for registration at the stages of requests and after refusals