Registration of medical devices
To bring a medical device to the Russian market, the manufacturer or his representative must go through the state registration procedure and receive a registration certificate. Registration of medical product is a state procedure, the purpose of which is to allow the release of high-quality and safe products to the Russian market, which falls under the competence of Federal Service for Surveillance in Healthcare (Roszdravnadzor) on the basis of the positive conclusion of the quality and safety of the declared medical product.
The following classes of medical devices are distinguished:
•Risk class 1;
•Risk class 2a;
•Risk class 2b;
•Risk class 3.
To register a medical device, to Roszdravnadzor must be submitted a properly prepared package of documents consisting of:
•information on regulatory documentation;
•results of technical, toxicological, tests for the approval of the type of measuring instruments;
•power of attorney from the manufacturer;
•permission to import into the country;
•inventory of documents;
•other documents, depending on the characteristics of the medical products.
During the formation of this package, it is important that all documents must be prepared in accordance with the requirements of the Federal Service for Surveillance in Healthcare and current legislation. This process requires knowledge and attention, expertise and experience. For example, it is important to control a single name and purpose, both in all documents of the manufacturer, and in test reports. Special attention should be paid to the registration application: it is necessary to correctly assign the name, describe the composition of the medical device, select, if necessary, accessories.
One of the areas of practice of BRACE Law Firm is the provision of services for the registration of medical devices.
We provide support for both the complete registration process and its individual stages, as well as provide legal services in the field of medical devices circulation.
So, in particular, our services in this direction include:
- Support of the registration of a permit for importing a medical device into the territory of the Russian Federation for the purpose of registration;
- Preparation of an application for state registration of a medical devic
- Assistance in the preparation and/or verification of technical and operational documentation in accordance with legal requirements;
- Support of technical, toxicological tests, electro-magnetic compatibility of medical devices (EMC) (if necessary);
- Forming a dossier, checking the completeness of documents;
- Accompanying clinical trials;
- Consultation on the registration of medical products.
Also, despite the careful preparation of documents, applicant must be prepared to receive requests from the registering authority. Requests sent by the Federal Service for Surveillance in Healthcare require adequate responses in the manner and time specified by law. Missing these deadlines threatens to refuse to register products.
In this regard, services of BRACE Law Firm include preparing responses to received requests and interaction with the Regional Board and other organizations on issues related to the state registration of medical devices.