Peru
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

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.

Last updated on January 29 2015.



Interested in obtaining fast market approval for your medical device or IVD in Peru? REQUEST A FREE QUOTE>

For more information on registration in Peru, check out the following articles on our blog:
Country at a Glance: Peru
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