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.
Last updated on November 5th, 2021.
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 into Classes I, II, III, and IV. IVDs do no have classification.
TIMEFRAME: New registration for both medical devices and IVDs will take up to 8 months.
SPECIAL REQUIREMENTS: Local testing, local clinical study, and foreign manufacturer on-site inspection are not required.
LOCAL FEES (New Application):
Medical devices (class I): USD 462
Medical devices (class II): USD 524
Medical devices (class III): USD 611
Medical devices (class IV): USD 685
IVDs (all classes): USD 513
LOCAL FEES (Manufacturer): N/A
LICENSE VALIDITY: Licenses issued in Peru expire after five years.
LICENSE TRANSFER: License transfer is possible. The application must be performed by the holder of the registration certificate by submitting a document called Ownership Assignment.
AUTHORIZED REPRESENTATIVE: A foreign manufacturer must appoint an authorized representative as an in-country representative and liaison with DIGEMID.
ADDITIONAL INFORMATION: All devices must be granted a registration certificate prior to their commercialization in Peru unless they are listed in the list of products that are not subject to product registration.
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