Our Guide For How to Register Medical Devices In Peru

This article was updated May 30, 2025

Regulatory Framework and Governing Bodies:

Peru’s regulatory framework for medical devices is primarily governed by the Law No. 29459 (Law of Pharmaceuticals, Medical Devices, and Health Products) and its amendments under Supreme Decree Nº 016-2013-SA. The Directorate of Sanitary Authorizations, under DIGEMID, is responsible for:

Registration and renewal of medical devices
Modifications and updates to existing registrations
Suspension and cancellation of Sanitary Registrations
Surveillance of post-market compliance

Device Classification:

Medical devices in Peru are classified based on risk level, duration of contact with the body, and invasiveness, following IMDRF guidelines. The classifications are:

Class I: Low-risk medical devices
Class II: Moderate-risk medical devices
Class III: High-risk medical devices
Class IV: Critical-risk medical devices

Medical Device Definition:

In Peru, a medical device includes instruments, equipment, software, and calibrators intended for:

Diagnostic, monitoring, treatment, or prevention of disease
Compensation of injuries
Maintenance and life support
Disinfection of medical devices
Contraception

Registration Dossier Requirements (By Class):

Requirements	Class I	Class II	Class III	Class IV
Application	✔	✔	✔	✔
CFS/CFG or analogue	✔	✔	✔	✔
QMS Certificate	✔	✔	✔	✔
Technical Report	✔	✔	✔	✔
Instruction for Use	✔	✔	✔	✔
Quality Standards (FDA/CE)		✔	✔	✔
Risk Analysis		✔	✔	✔
Clinical Evaluation			✔	✔
Biological Safety Data			✔	✔
Post-Market Surveillance			✔	✔
List of Countries Marketed				✔

Step-by-Step Registration Process:

I. Verify Procedures via VUCE:

Procedures for medical device registration must be verified through the Ventanilla Única de Comercio Exterior (VUCE). More info.

II. Access the VUCE Portal:

Go to the VUCE Portal.
Authenticate using Clave SOL.

III. Create a User Account:

IV. Create a Request (SUCE):

Select the appropriate TUPA format for the medical device and submit documentation.

V. Review and Evaluation:

DIGEMID reviews the submission based on risk classification.

VI. Issuance of Registration Certificate:

Upon approval, a certificate valid for 5 years is issued.

VII. Renewal Process:

Submit a renewal application before expiration.

Registration Timelines and Fees:

Device Class	Timeline (Days)	*Fee (USD)
Class I	60	400
Class II	90	460
Class III	120	510
Class IV	120	580

*Approximately

QMS Requirements:

DIGEMID requires a robust Quality Management System (QMS) aligned with ISO 13485 standards for all device classes. The QMS should cover:

Design controls
Manufacturing processes
Post-market surveillance
Risk management procedures
Corrective and preventive actions (CAPA)

VUCE System and Digital Submissions:

The VUCE system facilitates the electronic submission of documents and inquiries. It streamlines the regulatory process, allowing manufacturers to:

Submit registration applications
Monitor review status
Request modifications and renewals

Adverse Event Reporting and Market Surveillance:

DIGEMID monitors pricing and adverse events through the Observatorio Peruano de Productos Farmacéuticos (OPPF), using R Studio for data analysis. Manufacturers must report:

Device identification details
Description of the adverse event
Root cause analysis
Corrective actions implemented

Clinical Trial Requirements:

Clinical trials are mandatory for Class III and IV devices to validate safety and efficacy.
Data generated from clinical trials must be included in the registration application.

National Initiatives and Regulatory Implications:

“Decenio de la Igualdad de Oportunidades para Mujeres y Hombres” – Promotes gender equality in healthcare, potentially influencing device approvals related to women’s health.
“Año de la Recuperación y Consolidación de la Economía Peruana” – Focuses on economic recovery, potentially prioritizing essential medical devices.

Regulatory Updates and Resources:

Resolution Ministerial N° 607-2024/MINSA: Draft regulation for in vitro diagnostic devices emphasizing stricter regulatory control. Read more
Resolution Ministerial N° 049-2025/MINSA: Updated Manual of Good Pharmacovigilance Practices, reinforcing adverse event monitoring. Read more
Pharmacovigilance Campaigns: Focus on increasing adverse event reporting for medical devices and drugs. Learn more

Conclusion:

Navigating the medical device regulatory landscape in Peru involves compliance with stringent documentation requirements, adherence to risk-based classification criteria, and maintaining robust post-market surveillance. By leveraging the VUCE system and staying informed of DIGEMID’s regulatory updates, manufacturers can efficiently align with Peruvian regulatory expectations for successful market entry and device maintenance.

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