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.