. Submitting documents to the reference state (Roszdravnadzor).
2. The reference state's organization posts the electronic registration dossier on the EAEU's information website. The following activities take place:
— expert examination to assess the safety, efficacy and quality of the medical device (to be performed by experts of Roszdravnadzor);
— inspection of the production process for medical devices of Risk Class 2b and 3 risk class, sterile medical devices of Risk Class 2a;
— preparation of an expert opinion.
Not approved: Regfort makes adjustment subject to the experts' comments and resubmits the revised dossier.
4. Coordinating the expert opinion with experts from other countries with regard to the opinion.
3. Submitting the dossier to experts of the recognizing state for approval.
Resolving disagreements with the Eurasian Economic Commission.
The expert organization of the recognizing state provides comments or issues a rejection notice. Regfort assumes the responsibility for communicating and making amendments to documents prior to approval.
5. Registering and including the medical device in a unified register. This opens access to the common EAEU market.