Regulatory Authority In Peru, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) is the National Authority that oversees the medical devices, equipment, pharmaceutical products, personal care, and health products market. Summary of Peruvian regulatory legislation Is it necessary to obtain authorization to operate as a company prior to marketing restricted products? Yes, according to
Laser, IPL and radiofrequency equipment for use in aesthetics A device for use in aesthetic medicine is classified biomedical, active, non-invasive, or minimally invasive device that acts through the administration or exchange of energy in the form of non-ionizing radiation, to or from the human body. Most of the equipment in this category belongs to
The National Authority of Pharmaceutical Products, Medical Devices, and Health Products has reduced the maximum period of evaluation for the inscription and reinscription of medical devices in the Peruvian sanitary registry. Medical Devices (MD) Class I, low risk: Up to thirty (30) calendar days. Medical Devices (MD) Class II, moderate risk: Up to sixty (60)