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):

Step-by-Step Registration Process:

1. Verify Procedures via VUCE:
• Procedures for medical device registration must be verified through the Ventanilla Única de Comercio Exterior (VUCE). More info.
2. Access the VUCE Portal:
• Go to the VUCE Portal.
• Authenticate using Clave SOL.
3. Create a User Account:
• Register as a Secondary User using the RUC (tax identification number).
4. Create a Request (SUCE):
• Select the appropriate TUPA format for the medical device and submit documentation.
5. Review and Evaluation:
• DIGEMID reviews the submission based on risk classification.
6. Issuance of Registration Certificate:
• Upon approval, a certificate valid for 5 years is issued.
7. Renewal Process:
• Submit a renewal application before expiration.

Registration Timelines and Fees:

*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.