Regulatory Medical Device Registration in Peru

  • REGULATORY AUTHORITY: Medical devices are regulated by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas).     
  • CLASSIFICATION SYSTEM: Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV. 
  • TIMEFRAME: The approval process takes about 4-5 months.   
  • LICENSE VALIDITY: Licenses issued in Peru expire after five years.     
  • AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in Peru.
  • ADDITIONAL INFORMATION: Radioanalysis devices must receive additional authorization from the Nuclear Regulatory Authority.