Authorized Representative Function

Both for medical devices and pharmaceutical products it is necessary to have the authorized representative company in Russia and EEU to respond to customers and authorities claims and collect information about side and adverse effects. Entrust RegMed with this function and remain independent from your distributor.

RegMed takes upon itself all the functions of authorized representative company:

• Informing Manufacturer of changes in healthcare legislation or other legislation which influences deliveries, turnover and sales of the relevant medical product (pharmaceutical) within the Russian Federation and Eurasian Economic Union territory;
• Responding to all complaints and inquiries received from consumers and state supervisory authorities;
• Informing Manufacturer of all complaints or inquiries received from consumers and state supervisory authorities, as well as of legal claims and other requirements of state supervisory authorities;
• Monitoring validity of certification.
• Actions on state control over the circulation of medical devices, safety monitoring, clinical monitoring, including receiving, submitting messages, reports, claims, requests; providing explanations; forming, coordinating action plans and implementing measures to prevent or reduce risks to health and life, recall or replacement of medical devices, etc.
• Cooperation with competent authorities in relation to any preventive or corrective actions taken to eliminate or, if this is not possible, reduce the risks associated with Medical Devices;
• Immediately inform the Manufacturer (producer) of claims and messages from healthcare professionals, patients and users about suspected incidents related to the Medical Device for which it is intended.

We always can discuss and add some more function and make our cooperation the most effective and beneficial.

Here we have listed the main functions of ARC (authorized representative company).