Submission by the applicant of the documentation for the Мedical device for primary analysis

Applicant's choice of states of recognition [Belarus, Kazakhstan, Armenia, Kyrgyzstan]

Finalization of the documentation in accordance with the requirements of the Roszdravnadzor (decision No. 46 EEC)

Testing of medical devices

Coordination of test reports, verification / correction

Formation of the registration dossier / Submission to the RZN for registration

Expert committee report [30 working days]

Translation and notarization of documents

Expertise of quality management, visit of RZN experts to the production site. For products 2a (sterile), 2b, 3 risk classes. [90 working days] - Expert committee report [30 working days]

Checking the completeness and reliability of the dossier provided in the register [5 working days]

if RZN made a comment (request)

Eliminate of the remark
[the regulated period is 30 working days]

Re-submission to the RZN for checking the completeness and reliability of the information

if the remarks are not resolved

Refusal to register

The information provided in the registration dossier is presented is full

Beginning of registration of medical devices and examination

Expertise of MD [60 working days]

If the expert center issues a remark

Elimination of the remark
[the time limit is 60 working days]

If the comments are not resolved

Refusal to register

Coordination with the countries of recognition [30 calendar days]

RC

Refusal to register the country of recognition

Remarks removed

The examination was successful