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 market 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clinics are prohibited by law from using unregistered, falsified, substandard, counterfeit or other medical devices withdrawn from circulation by regulator.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 (fillers), 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<0.05). Information about unregistered medical devices prevails with exception of implant gels (p<0.05).

CONCLUSION

Percentage of medical devices illegally available in cosmetology has not decreased over the past 10 years. It is necessary to strengthen internal control over the safe use of medical devices in cosmetology clinics.