MEDICAL DEVICE REGISTRATION AND APPROVAL IN Peru

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 update: December 2022

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 INFORMATIONAll 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.

Other South American Countries: Argentina, Brazil, Chile, Colombia, Ecuador, Uruguay, Venezuela

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