Medical Device Registration and Approval in Peru
General country-specific regulatory information is provided on this page for medical device registration and approval in Peru. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Peru, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification 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.
Last updated on January 29 2015.
For more information on Medical Device Registration in Peru, check out the following articles:
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