State registration of medical products and devices

Association of Dental Manufacturing and Trading Enterprises "RUSSIAN DENTAL INDUSTRY" provides services in registration of medical products and devices on a “turnkey” basis.

Our employees will help you to prepare all necessary documents, carry out all tests of your product in designated accredited organizations within the shortest possible time and on favorable terms.

On completing the registration procedure your company will obtain the Registration Certificate and the Declaration of Compliance, the documents which are necessary and sufficient for the disposal of medical products and devices within the territory of the Russian Federation. Fill in the application and send it to info@rosi-reg.com for the assessment of the estimated time and cost of the registration of your medical product.

State registration stages

1 Technical tests, toxicological researches, tests in order to certify the type of measuring devices

2 Filling of an application about registration and submission of documents in the Federal Supervisory Agency for Health Care

3 Preexamination: verification of the completeness and the accuracy of the information given in the documents		Denial of registration in case of any inconsistencies of the documents

4 Examination 1st stage. Verification of documents in order to estimate of possibility of carrying out clinical tests of the product		Decision on impossibility of carrying out clinical tests. Denial of registration.

5 Carrying out clinical tests in the accredited medical organizations

6 Examination 2nd stage. Verification of the completeness and the results of the carried out tests and researches		Denial of registration.

Issue of the registration certificate

	Association of Dental Manufacturing and Trading Enterprises RUSSIAN DENTAL INDUSTRY +7 (916) 853 04 57 info@rosi-reg.com
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State registration of medical products and devices

State registration stages

Results of the state registration