Why choose us
Why does a manufacturer need an authorized representative?
For foreign manufacturers of medical devices, the presence of an authorized representative on the territory of the Russian Federation is a mandatory legal requirement. Without the appointment of an authorized representative, state registration of a medical device is impossible.
An authorized representative of the manufacturer (AMR) is not just an intermediary between the manufacturer and Roszdravnadzor. This is a legal entity that acts on behalf of the manufacturer on the territory of the Russian Federation and is responsible for fulfilling the legal requirements in relation to the registered medical device.
It is the authorized representative who interacts with Roszdravnadzor, expert organizations and testing laboratories, ensures the relevance of the registration dossier, participates in post-registration procedures and represents the interests of the manufacturer throughout the entire period of circulation of the medical device on the Russian market.
What is included in the service
We perform the functions of an authorized representative of the manufacturer in full, including:
- official representation of the interests of the manufacturer on the territory of the Russian Federation;
- participation in the state registration of medical devices;
- interaction with Roszdravnadzor, expert organizations and testing laboratories;
- preparation, submission and support of registration documentation;
- support of procedures for making changes to the registration dossier (VIRD);
- participation in post-registration support of medical devices;
- consulting the manufacturer on compliance with the requirements of the legislation of the Russian Federation;
- prompt interaction with government authorities when queries and regulatory issues arise.
Responsibility of the authorized representative
Appointment of an authorized representative is a long-term cooperation that does not end after receiving a registration certificate.
We accompany the manufacturer throughout the entire period of circulation of a medical device, monitor compliance with regulatory requirements, promptly inform about changes in legislation and provide the necessary support if any issues arise related to the registration and circulation of products on the territory of the Russian Federation.
If necessary, our specialists accompany changes to the registration dossier, organize interaction with Roszdravnadzor and expert organizations, and also help the manufacturer fulfill all obligations stipulated by current legislation.
Result
By appointing our company as an authorized representative, you get a reliable partner who provides legal representation of your interests in the Russian Federation, undertakes support of registration and post-registration procedures and helps to comply with the requirements of Russian legislation throughout the entire life cycle of a medical device.
