Authorized Representative services for medical devices and IVD-bg

Authorized Representative services for medical devices and IVD

In order to understand the role and importance of having an authorized representative of the manufacturer of medical device in the Russian Federation (AR), first of all, it is necessary to pay attention to the definition of AR in the Russian Federation Decree dated 27 December 2012 No.1416 «On the approval of the rules state registration of medical devices» [i] (RF Government Decree 1416):

"Authorized representative of the manufacturer" - a legal entity or individual entrepreneur registered in the territory of the Russian Federation, authorized by the manufacturer of a medical device to represent his interests on matters of circulation of the medical device in the territory of the Russian Federation, including the issues of conformity assessment and state registration procedures, in whose name a registration certificate for the medical device may be issued;

From the definition we can conclude that AR:

  1. represents the manufacturer on the issues of medical device circulation in the Russian Federation (usually on the basis of a power of attorney);
  2. must be a resident of the Russian Federation.

The concept of “circulation of a medical device” is a “collective” term for many stages of the life cycle of a medical device; its definition is given in paragraph 3 of Article 38 of the Federal Law of 21.11.2011 No. 323-FZ “On the Fundamentals of Health Protection of Citizens in the Russian Federation” [ii]:

"3. Circulation of medical devices includes technical testing, biocompatibility testing, clinical trials, examination of the quality, efficiency and safety of medical devices, their state registration, production, manufacturing, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of conformity, storage, transportation, sale, installation, adjustment, use, operation, including maintenance provided by regulatory, technical and (or) operational documentation of the manufacturer, as well as repair, disposal or destruction..."

Based on the definition, the AR can represent the manufacturer's interests both before and during the stages of assessment of compliance of a medical device (MD) with the requirements (registration/obtaining a registration certificate), and after - during the circulation of the MD on the market until its export or disposal.

Let's consider examples of those processes (stages) in which the AR can and/or must take part:

  1. Collection of the registration dossier, including the organization of biocompatibility testing, technical testing, clinical trials, and factory audit (for class 2a sterile medical devices, 2b and 3) [iii][iv];
  2. Submission of notifications on the import of samples for the purpose of registration of medical devices and/or amendments to the registration dossier;
  3. Development and submission of a clinical monitoring report (for medical devices of risk class 3, implantable medical devices of risk class 2b) [v];
  4. Submission to Roszdravnadzor of information on the occurrence of adverse events during the use of a medical device;
  5. Preparation and submission of a report on corrective actions to Roszdravnadzor on the safety of use of a medical device;
  6. Submission of statement for an amendment process to update the information in the registration dossier, in accordance with the requirements of RF Government Decree 1416.

An authorized representative of the manufacturer can and should participate in all stages of the life cycle of medical devices on the territory of Russia; the long-term application of MD in Russia, as well as the quality and safety of MD application, depends primarily on the integrity of the AR.

[i][i] https://base.garant.ru/70291692/

[ii] https://www.consultant.ru/document/cons_doc_LAW_121895/ddcfddbdbb49e64f085b65473218611b4bb6cd65/

[iii] http://publication.pravo.gov.ru/document/0001202402090045

[iv] https://base.garant.ru/403517950/

[v] https://base.garant.ru/75011335/

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