TY - JOUR

T1 - Применение законно находящихся в обращении медицинских изделий — основа безопасности деятельности косметологической клиники

AU - Акулин, Игорь Михайлович

AU - Груздев, Денис

AU - Chesnokova, E.a.

AU - Махова, Ольга Александровна

PY - 2022/1/1

Y1 - 2022/1/1

N2 - Objective. To study legal regulation for cosmetology clinics as subjects of circulation of medical devices and regulator’s messages about prohibited medical devices. Material and methods. We analyzed the regulatory legal acts of the Russian Federation defining mandatory requirements for medical devices. The reports of the Federal Service for Surveillance in Healthcare about medical products specific in cosmetology for all participants of the mar-ket were studied: threads, implant gels, biorevitalizants, cosmetology devices available with violations of legal requirements. Results. Cosmetology clinics are prohibited by law from using unregistered, falsified, substandard, counterfeit or other medical devices with-drawn from circulation by regulator. One can receive information about registered medical devices and those that need to be discontinued on the Roszdravnadzor website. Roszdravnadzor published reports on 140 medical devices specific to cosmetology (threads, gel-implants (fill-ers), biorevitalizants, cosmetology equipment) for the period from 2012 to 2021. Percentage of medical devices illegally available in cosmetology has not decreased over the past 10 years (0.6% in 2021). Reports on illegally available cosmetology equipment prevail (59%, p

AB - Objective. To study legal regulation for cosmetology clinics as subjects of circulation of medical devices and regulator’s messages about prohibited medical devices. Material and methods. We analyzed the regulatory legal acts of the Russian Federation defining mandatory requirements for medical devices. The reports of the Federal Service for Surveillance in Healthcare about medical products specific in cosmetology for all participants of the mar-ket were studied: threads, implant gels, biorevitalizants, cosmetology devices available with violations of legal requirements. Results. Cosmetology clinics are prohibited by law from using unregistered, falsified, substandard, counterfeit or other medical devices with-drawn from circulation by regulator. One can receive information about registered medical devices and those that need to be discontinued on the Roszdravnadzor website. Roszdravnadzor published reports on 140 medical devices specific to cosmetology (threads, gel-implants (fill-ers), biorevitalizants, cosmetology equipment) for the period from 2012 to 2021. Percentage of medical devices illegally available in cosmetology has not decreased over the past 10 years (0.6% in 2021). Reports on illegally available cosmetology equipment prevail (59%, p

KW - biorevitalizants

KW - cosmetology

KW - fillers

KW - medical devices

KW - thread lifting

UR - https://www.mendeley.com/catalogue/a72db5d7-0561-3b73-aac0-30bfbdbb0235/

U2 - 10.17116/plast.hirurgia202204160

DO - 10.17116/plast.hirurgia202204160

M3 - статья

SP - 60

EP - 65

JO - Plastic Surgery and Aesthetic Medicine

JF - Plastic Surgery and Aesthetic Medicine

SN - 2686-7346

IS - 4

ER -