Comparative analysis of regulatory models for medical devices: national regulations and international guidelines

Ivanov I.V.; Berseneva E.A.; Agamov Z.Kh.; Zinovieva E.V.

doi:https://doi.org/10.17116/profmed20222505114

Ivanov I.V.

National Institute of Quality of Roszdravnadzor

Berseneva E.A.

Federal State Budgetary Institution «Natsional’nyj institut kachestva»;
Russian Presidential Academy of National Economy and Public Administration

ORCID: 0000-0003-3481-6190

Agamov Z.Kh.

N.A. Semashko National Research Institute of Public Health

ORCID: 0000-0002-3745-4888

Zinovieva E.V.

National Institute of Quality of Roszdravnadzor

Comparative analysis of regulatory models for medical devices: national regulations and international guidelines

Authors:

Ivanov I.V., Berseneva E.A., Agamov Z.Kh., Zinovieva E.V.

More about the authors

Journal: Russian Journal of Preventive Medicine. 2022;25(5): 14‑20

DOI: 10.17116/profmed20222505114

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To cite this article:

Ivanov IV, Berseneva EA, Agamov ZKh, Zinovieva EV. Comparative analysis of regulatory models for medical devices: national regulations and international guidelines. Russian Journal of Preventive Medicine. 2022;25(5):14‑20. (In Russ.)
https://doi.org/10.17116/profmed20222505114

Подписка 2026 Профилактическая медицина (Russian Journal of Preventive Medicine)

Использование инфографики авторами научных работ

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Abstract:

The main trends in the development of legal regulation in the field of circulation of medical devices, which are typical for the leading healthcare systems of the world, are presented. The main trends and changes that have occurred in the legal regulation of the circulation of medical devices are considered. The domestic and foreign experience in ensuring the safety of medical devices is analyzed, the main approaches to regulating the circulation of medical devices implemented by the expert communities of the most developed healthcare systems are presented.

Keywords:

safety of medical activity

regulatory and legal regulation in the field of circulation of medical devices

medical device

quality assurance and safety of medical devices

international models for regulating the circulation of medical devices

agreed tools

international safety standards

Authors:

Ivanov I.V.

National Institute of Quality of Roszdravnadzor

Berseneva E.A.

Federal State Budgetary Institution «Natsional’nyj institut kachestva»;
Russian Presidential Academy of National Economy and Public Administration

ORCID: 0000-0003-3481-6190

Agamov Z.Kh.

N.A. Semashko National Research Institute of Public Health

ORCID: 0000-0002-3745-4888

Zinovieva E.V.

National Institute of Quality of Roszdravnadzor

Received:

04.03.2022

Accepted:

27.03.2022

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References:

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