Registration and examination of a medical device at stage 2 is carried out in 4 steps:
Step No.1. Submitting Documents to the Selected Authority of the Selected State
The document is provided in accordance with international certification standards or certification standards established in accordance with the legislation of the member state of the Eurasian Economic Union. The package of documents includes the following:
- Application for examination and registration of a medical device (on paper and/or electronic media) in the form in accordance with Appendices No. 2 and 3;
- Registration dossier on an electronic medium containing documents on the list in accordance with Appendix No. 4 (in the event that the legislation of a Member State does not provide for the preparing of the aforementioned documents in electronic form, the authorized body of the Reference Member State is entitled to request such documents (or copies thereof) on paper. In this case, documents submitted in a foreign language must be translated in authentic manner into Russian, certified in accordance with the procedure established by the legislation of the Member State.
Requirements for the electronic form of applications and documents of the registration dossier submitted during the registration and expert examination of the safety, quality and effectiveness of medical devices approved by the decision of the ECE Board dated 30.06.2017 No. 78);
- Copies of documents confirming payment of customs duties in the selected country.
The authorized body of the reference state shall check the completeness and accuracy of the information provided by the applicant, shall make a decision on the commencement of the procedure for registration and expert examination of the medical device and places the application and registration dossier in its information system. These actions shall be completed within 5 working days. If there are any comments, the applicant is given the opportunity to fix them. The period for fixing is 30 working days. Then, within 3 working days as from the date of receipt of the application and registration dossier, which fully complies with the requirements of the Rules, the authorized body makes a decision on the commencement of the procedure for examination and registration of the medical device.
Step No. 2. Performing an Expert Examination of the Medical Device
In accordance with paragraph 7 of the Rules for the purposes of registering a medical device by an examination of the medical device is carried out by an expert organization determined by the authorized body of the member state (hereinafter referred to as the expert organization). This expert organization shall prepare an expert opinion, which is essentially the key document of the registration dossier.
The applicant is given no more than 60 working days to eliminate the identified deficiencies. The time of the inspection of the production of medical devices is not included in the expert examination period. After the expert opinion is issued, the authorized body notifies the applicant of the need to submit copies of documents on payment for the expert examination and registration in the states of recognition. The applicant shall submit the specified documents within 10 working days.
Step 3. Coordination of the Expert Opinion by the Concerned Member State
After confirmation that the applicant has fulfilled all requirements, the authorized bodies of the Concerned Member State shall send confirmation of approval (non-approval) of the expert opinion. No more than 30 working days should pass from the date the opinion is posted in the information system until the final decision is made. The executive bodies supervising the state shall receive notification of the decision taken.
Step No. 4. Issuance of a Registration Certificate for a Medical Device
The final stage involves registration of the medical device, which is carried out by the Reference Member State based on the results of the examination of the medical device and the approval of the expert opinion by the Concerned Member State (clause 10 of the Rules). If a decision is made to register the medical device, the authorized body of the Reference Member State, within no more than 10 working days, shall place information about the medical device registered within the EAEU, the user manual (instructions for medical use) and an image of the approved labeling of the medical device in the Unified Register Of Medical Devices. The authorized body of the Reference Member State shall issue a registration certificate and an appendix to it within 10 working days of the decision to register the medical device.
Information on the progress of reviewing documents for which Russia has been selected as the Reference Member State is posted on the Roszdravnadzor website and is available for opening by indicating the incoming application number.
The registered device is marked with a special EAEU symbol.