Authorized representative of the manufacturer

The company KС-PROF provides the service of acting as an authorized representative of a manufacturer of medical devices in the Russian Federation and the EAEU. Let us study the intricacies of this aspect of the medical devices circulation together.

Who is an authorized representative of the manufacturer?

The authorized representative of the manufacturer on the territory (ARM) on the territory of the Russian Federation (RF) is an organization or an individual entrepreneur who resides in Russia and is authorized in accordance with the power of attorney issued by the manufacturer of the medical device to represent its interests and bear responsibility concerning the circulation of the medical device in the Russian Federation and the execution of mandatory requirements for medical devices.

Who needs an authorized representative of the manufacturer (ARM) on the territory of the Russian Federation?

Following the requirements of the Rules of state registration of medical devices approved by the Decree of the Government of the Russian Federation No. 1416 dated 12/27/2012 and the Rules of registration and examination of the safety, quality, and effectiveness of medical devices approved by the Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016, all foreign manufacturers of medical products which are currently in circulation in Russia should have an authorized representative. For a foreign manufacturer, the presence of an authorized representative is a prerequisite for the legal circulation of medical devices both on the territory of the Russian Federation and within the EAEU (if one chooses several states of recognition during the registration of a medical device by the EAEU Rules).

When should one choose an authorized representative of the manufacturer?

Since the circulation of medical devices on the territory of the Russian Federation for foreign manufacturers begins with the state registration procedure, the ARM should be chosen no later than one applies for the permission to import samples of the registered medical device into the Russian Federation, because to obtain this document one needs to contact the Federal Service for Supervision of Health Care of the Russian Federation (Roszdravnadzor).
In case when the manufacturer needs to change its ARM to another one, the new ARM should begin to perform its duties immediately after the former authorized representative ceases to perform its duties. In this case, it is necessary to inform Roszdravnadzor about the change of AMR within 30 days.

What are the duties of the ARM?

Based on the definition of ARM, they take full responsibility for the circulation of medical devices of foreign manufacture on the territory of the Russian Federation and the cases when there is a need to carry out the procedures established by regulatory enactments. The main functions and responsibilities of the ARM are the following:

– implementation of work on registering medical devices and introducing relevant amendments to the valid registration documents;

– interaction with consumers of medical devices regarding the issues of their quality, safety and effectiveness;

– interaction with Roszdravnadzor in the event of adverse events related to the circulation of a medical device;

– interaction with the manufacturer in order to obtain the necessary documents, information or other resources necessary to comply with the requirements of the legislation of the Russian Federation in the sphere of the medical devices circulation.

Thus, performing the ARM duties requires extensive knowledge in the field of legislation governing the circulation of medical devices. Therefore, the choice of an authorized representative should be approached with prudence and attention. This approach will avert problems related to the various aspects of medical device treatment in the future.

Violation of the legislation in the field of medical devices circulation can lead to administrative, and in some cases criminal liability. In addition to that, certain issues may lead to the suspension or termination of approval documents for medical devices (including registration certificates), which entails serious financial losses.

What is the cost of service for performing the ARM duties?

Considering the practically infinite variety of medical devices (different risk classes of use, active/inactive, sterile/non-sterile, disposable/reusable, implantable/non-implantable/for in-vitro diagnostics) and the fact that the manufacturer may require services of the ARM at various stages of medical devices circulation (registration, distribution and sale, post-sales monitoring), establishing a fixed price for this service is not possible. Therefore, the cost is calculated individually based on the amount of manufacturer’s medical products in circulation in the Russian Federation, their classification and the extent of our company’s involvement in solving various issues that arise in the process of performing the ARM duties.

The company KC-PROF is ready to provide services as an authorized representative of the manufacturer (ARM) both during the state registration of medical devices and during their further circulation on the markets of Russian and the EAEU after receiving a registration certificate and beginning the sales of medical equipment (ME) and medical devices.

Get a free consultation and calculation of the cost of work on this service!