A comprehensive guide to medical device registration in Peru through DIGEMID. Learn about the four-class risk system under Law 29459, documentation requirements, local holder obligations, and timelines for successful market access.
Introduction: Peru's Medical Device Regulatory Framework Peru is an increasingly important market for medical devices in Latin America, with growing healthcare expenditure and expanding access to modern medical technologies. The country's regulatory framework provides clear pathways for medical device registration, making it an accessible market for manufacturers with proper preparation. Medical device regulation in Peru is administered by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), the General Directorate of Medicines, Supplies and Drugs, operating under the Ministry of Health. The primary legislation governing medical device registration is Law 29459 (Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios). Understanding DIGEMID: Peru's Regulatory Authority DIGEMID is the national regulatory authority responsible for the registration, surveillance, and quality control of pharmaceuticals, medical devices, and health products in Peru. DIGEMI…