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.

Last updated on January 29 2015.



ARE YOU INTERESTED IN REGISTRATION 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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