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.

Other South American Countries:

Argentina, Brazil, Chile, Colombia, Ecuador, Uruguay, Venezuela