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.