REGULATORY AUTHORITY: Medical devices are regulated by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas).

CLASSIFICATION SYSTEM:

• Medical devices: Classes I, II, III, and IV.
• IVDs: IVDs in Peru do not have a predefined risk classification system. They are nevertheless fully regulated and subject to registration, with documentation requirements determined by the authority based on the product’s intended use and technical/analytical evidence submitted.

TIMEFRAME New registration for both medical devices and IVDs will take up to 8 months.

LICENSE VALIDITY: Licenses issued in Peru expire after five years.

LOCAL FEES (New Application):

• Medical devices:
• • Class I: USD 400
  • Class II: USD 450
  • Class III: USD 500
  • Class IV: USD 550

• IVDs: USD 500

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.

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