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

Medical Device Registration in Peru

• 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