Features and benefits of registration of medical devices in the EAEU
- The certificate is valid indefinitely
- It is possible to choose in which countries the registration will be carried out: in one, several or all five at once
- To obtain RU, it is necessary that the manufacturer of the medical device is a resident of one of the EAEU countries
- When registering in the EAEU, a medical device is checked according to more stringent requirements than when registering only at the national level. In the long term, this provides the manufacturer with significant benefits. RU is a kind of quality mark and favorably distinguishes a medical device from competitors
Rules and stages of registration of medical devices
We are ready to accompany you at all stages until the successful receipt of RC for your medical device.
- Registration dossier preparation:
- At this stage, we analyze the documents, check that they meet all the requirements of the registration authorities (in Russia, the registration of medical devices is handled by Roszdravnadzor).
- We help to draw up technical specifications (for foreign manufacturers - a technical file), instructions for use, operating instructions for medical devices.
- We help to determine the country or country of recognition.
- If necessary, we obtain permission to import product samples and pay the state duty in the reference countries.
- Testing and submission of the registration dossier:
- We organize toxicological, technical and clinical trials.
- We submit the dossier to the registration authority.
- If you have any questions or comments, we eliminate them and modify the technical and operational documentation.
- After that, the registration authority decides to start the registration procedure.
- Expertise and execution of an expert opinion:
- The product is being examined.
- In case of any claims, we will help to eliminate them.
- An expert organization conducts on-site inspection and verifies compliance with production requirements.
- Then he draws up an expert opinion and coordinates it in all countries of recognition.
- Registration of RU:
- The registering authority places information about the product on its resources.
- Draws up RU and its annexes. They are valid indefinitely, so re-registration is not required.
Do you want to discuss your situation and entrust us with the receipt of an RC for a medical device?
We will be happy to help you.