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.
Last updated on January 29 2015.
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For more information on registration in Peru, check out the following articles on our blog: Country at a Glance: Peru