The regulatory authority for medical devices in Peru
The regulatory authority for medical devices in Peru is the General Directorate of Medicines, Medical Supplies, and Drugs (DIGEMID), which is primarily responsible for the registration, supervision, and management of medical devices; document review; technical evaluation; safety testing; quality management system audits; and the approval of medical device marketing authorizations.
Link to the regulatory agency’s official website:https://www.digemid.minsa.gob.pe/webDigemid/
Database link: https://www.digemid.minsa.gob.pe/rsDispositivos/
Regulatory Framework
Law No. 29459 and its amendments, Supreme Decree No. 020-2024-SA
Supreme Decree No. 016-2011-SA and its amendments, Supreme Decree No. 010-2023-SA
Medical Device Risk Classification
| Class Category | Risk Level | Example |
|---|
| Class I | Low Risk | Examination gloves, latex examination gloves, bandages |
| Class II | Low‑moderate Risk | Aspirators, infusion sets, emergency respiratory devices, syringes with needles |
| Class III | Moderate‑high Risk | Hemodialyzers, pulse oximeters, electrosurgical units, X‑ray machines |
| Class IV | High Risk | Absorbable surgical sutures, joint injectables, cranial drainage systems |
Authorized Representative
An entity legally established in Peru (with legal existence and a physical address), registered with DIGEMID and holding the appropriate authorization. Typically, this is a DIGEMID-authorized Establecimiento Farmacéutico (pharmaceutical establishment), such as a Droguería (wholesale/distribution company) or a laboratory.
Prerequisites for Market Access
Both MDs and IVDs require an ISO 13485 certificate to demonstrate the quality system at the actual manufacturing site;
For manufacturers located outside Peru, an Authorized Representative must also be designated to serve as the Peruvian Registration Holder (PRH);
The applicant must prepare detailed technical specifications, manufacturing processes, and information on materials used to enable the regulatory authority to assess the product’s quality and safety.
Registration Documents
Registration Language
Spanish
Registration Process, Timeline, and Official Fees
1.Registration Process
Standard Registration Process: Confirm product classification → Prepare registration documents → Designate a distributor → Submit documents to DIGEMID → Obtain the certificate (valid for 5 years)
2.Registration Official Fees & Timelines (Final determination by DIGEMID)
| Risk Class | Official Fee (S/) | Reference USD (2026 Exchange Rate) | Review Timeline |
|---|
| Class I Low Risk | 2724.90 | ~400 USD | 60 working days |
| Class II Low‑Medium Risk | 3160 | ~462 USD | 90 working days |
| Class III Medium‑High Risk | 3490 | ~510 USD | 120 working days |
| Class IV Extremely High Risk | 3940 | ~580 USD | 120 working days |
| IVD In‑vitro Diagnostic Reagents | 3160 | ~462 USD | 90 working days |
