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
According to D.R. No. 033-2017-DIGEMID-DG-MINSA, published early this year, DIGEMID issued a list of medical devices that may be marketed directly to end-users. This document does not list every medical device but establishes a criterion based on MD risk classification. Medical Devices Class I, II, III, and IV Laboratories and droguerías (pharmaceutical establishments) may directly