Devices with Aesthetic Purposes
Regulatory pathways, clinical and safety evaluations
Regulatory Pathways: How to Classify Devices for Aesthetic Purposes?
Devices for aesthetic purposes, whether used by health practitioners or consumers, can be classified as accessories, devices, goods, or medical devices.
Our regulatory experts help identify the most appropriate classification and the corresponding safety and efficacy requirements. We have extensive experience with various devices, including LED treatments, massagers, masks, spa equipment, microneedles, and face and body treatments.
Clinical and Safety Evaluations
Aesthetic devices classified as simple devices or goods must undergo evaluation by toxicologists to ensure their safety for both consumers and professional users. Claims and indications must be supported by a comprehensive scientific dossier to support treatment protocols.