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Peru

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Peru

Medical Device Registration in Peru

Ministry of Health

Ministry of Health of Peru

Regulatory Authority

Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)

Medical Device Regulation

  • Decree D.S.001-2012-SA
  • Decree D.S.016-2011-SA
  • Law No. 29.459
  • Decreto Supremo No. 003-2020-SA

Official Language

Spanish

Classification

Class I, II, III and IV

Registration Process

  • Appoint a local Authorized Representative
  • Prepare registration application and Technical Documentation
  • Once approved, DIGEMID will grant the product registration.
  • The medical device can now be marketed in Peru

Documents Required

  • Technical File according to Decree D.S.001-2012-SA and Decree D.S.016-2011-SA
  • QMS certificate
  • Labels and IFU
  • Post-market Surveillance Reports
  • Risk Management Plan

Applicable QMS

ISO 13485

Registration Timeline

  • Class I devices: 60 days.
  • Class II devices: 90 days.
  • Class III and IV devices: 120 days.

Authorized Representative

Yes

License Validity

5 years

Special Notes

Documents and Labelling must be in Spanish

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