Registration of medical devices in the EAEU-bg

Registration of medical devices in the EAEU

Registration of medical devices within the Eurasian Economic Union (EAEU) is carried out in accordance with the Decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 46 “On the rules of registration and examination of safety, quality and efficiency of medical devices”. The process of registration of a medical device (MD) can be divided into 2 large stages: preparation of the dossier and review of the dossier.

Dossier preparation procedure

The list of the documents required for registration of a medical device is set out in Appendix No. 4 to the Rules, Decision of the EEC Council of 12.02.2016 No. 46 and depends on the risk class. One of the most important moments of dossier preparation is the collection of evidence of safety and efficiency. For this purpose, the applicant conducts the following types of tests:

•         Technical testing (for all devices except for in vitro diagnostic MD).

•         Tests (research) for the purpose of assessing the biological effect of a medical device (for MD that come into contact with the surface of the human body, its mucous membranes, and the internal environment of the body).

•         Clinical trials (research) (for all MD).

•         Tests for the purpose of approving the type of measuring instruments (for MD classified as measuring instruments, according to the Decision of the EEC Council dated 12.02.2016 No. 42).

All tests must be conducted in accredited testing institutions. Also, when preparing the registration dossier, the reference state and at least one recognition state from the EAEU members are determined. The dossier additionally provides instructions for use in the state language of the recognition states.

Registration procedure

Step 1. Submission of documents

A registration dossier together with statements for examination and registration of MD, together with copies of documents confirming payment of government fees for examination and registration of MD in the reference state are submitted to Roszdravnadzor.

Step 2. Checking of completeness and accuracy of the information contained in the statement and registration dossier

This procedure takes 5 working days. According to the results of the test, there are 3 possible options:

•         Notification of refusal – 10 working days.

•         Request for correction of comments – 30 working days. If the comments are not corrected, a notification of refusal is issued.

•         Decision to initiate the examination and registration procedure of the medical device – 3 working days. If the documents are reliable and presented in full.

Step 3. Conducting an examination of medical device

For MD risk class 1 and 2a non-sterile

The examination is conducted by an expert organization within 45 working days. In case of violations, a request is sent, for the elimination of which 60 working days are given. In case of failure to eliminate the violations, a refusal notice is issued within 10 working days. If all comments are eliminated and the decision of the expert center is positive, then within 5 working days the registration dossier is placed in the information system and a notice is received about the need to pay government fees of the countries of recognition. 30 working days are given for payment. The applicant notifies the authorized expert center of the reference state and the states of recognition about the payment of government fees.

For MD, risk class 2a sterile, 2b and 3

The examination is conducted by an expert organization within 45 working days. In case of violations, a request is sent, for the elimination of which 60 working days are given. In case of failure to eliminate the violations, a refusal notice is issued within 10 working days. If all the comments are eliminated, the expert center makes a decision to begin the factory audit and notifies the applicant about it. The factory audit should not exceed 90 working days. The elimination of comments based on the results of the factory audit is sent by the inspecting organization to the expert center, which issues an expert opinion within 15 working days. If the conclusion is positive, within 5 working days the registration dossier is placed in the information system and a notification about the necessity to pay the government fees of the countries of recognition is received. 30 working days are given for payment. The applicant notifies the authorized expert center of the reference state and the states of recognition about the payment of government fees.

Step 4. Approval of the expert opinion by the States of recognition

Approval of the expert report by the countries of recognition lasts 30 working days from the date of receipt of the notification of payment of government fees. Disagreements are settled within 30 working days. The following developments are possible:

·          Non-approval of the expert conclusion of the reference state in one of the countries of recognition. In this case, a refusal to register the MD on the territory of one of the countries of recognition is received.

·          Decision on MD registration. Occurs in the case when there is an agreement of the expert opinion in at least 1 country of recognition.

Step 5. Posting in the unified register and registration certificate issuance.

Within 10 working days from the date of approval of the expert conclusion by the states of recognition, a decision is made on posting in the unified register of the Union: information about the medical device, instructions for use and images of the approved label. Then Roszdravnadzor issues a registration certificate and an appendix to it within 10 working days from the date of the decision on registration of the MD.

Thus, the examination and registration period may be approximately 12 months for devices that do not require the factory audit and approximately 16 months for devices that require the factory audit. 

 

 

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