At present,in the registration and inspection stage of medical cosmetic active medical devices,it is necessary to first develop product technical requirements.Some of the content of product technical requirements can refer to relevant industry standards or national standards.However,in order to reflect the characteristics of medical cosmetic active medical devices and ensure the effectiveness of the product during use,it is necessary to add specialized performance technical requirements on the basis of existing reference standards.Through research and analysis of current national and industry standards,combined with the specific application of medical beauty active medical devices,technical suggestions are proposed for the development of performance related indicators that reflect product characteristics in product technical requirements,in order to further improve and standardize the safety and effectiveness evaluation of medical beauty active medical devices for manufacturers,type inspection and technical evaluation departments,and provide reference.At the same time,an analysis and outlook were conducted on the regulatory and standard formulation and revision work for medical cosmetic devices in the future.
medical beautyactive medical devicestechnical requirementdiscuss
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