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Medical devices are regulated by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas).
Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV.
The approval process takes about 4-5 months.
Licenses issued in Peru expire after five years.
An authorized representative is required to register medical devices in Peru.
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