Medical Device Registration in
Ministry of Health
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
Class I, II, III and IV
- 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
- 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
- Class I devices: 60 days.
- Class II devices: 90 days.
- Class III and IV devices: 120 days.
Documents and Labelling must be in Spanish