Overview of the State Agency of Medicines (ZVA) and Medical Device Safety in Latvia

State Agency of Medicines (ZVA) - Medical Devices Overview

The State Agency of Medicines of the Republic of Latvia (ZVA) (Zāļu valsts aģentūra) is the competent national authority responsible for supervising the safety, quality, and compliance of medical devices within Latvia. Operating under the Ministry of Health, ZVA ensures that patients, public healthcare providers, and the market have access to compliant and safe medical technologies.

Key Roles and Responsibilities

ZVA protects public and patient health through several essential regulatory functions:

• The LATMED Register: ZVA maintains and operates the LATMED electronic database, which serves as the official national register for medical devices, manufacturers, and authorized representatives in Latvia.
• Notification Procedures: Manufacturers or distributors placing Class IIa, IIb, and III medical devices, active implantable devices, or specific in vitro diagnostic (IVD) medical devices onto the Latvian market must formally submit an electronic notification to ZVA via the LATMED system before distribution begins.
• CE Marking & Compliance: In accordance with European Union directives and regulations, all medical devices distributed in Latvia must bear a valid CE mark, confirming that the product has undergone necessary conformity assessments.
• Vigilance and Incident Reporting: ZVA acts as the central node for tracking and evaluating adverse incidents related to the use or operation of medical devices. Patients, healthcare professionals, and manufacturers are legally encouraged or mandated to report any malfunction or defect that has caused or could cause harm to human life or health.
• Public Information Access: The agency publishes accessible information for patients and consumers, allowing the public to verify registered devices and learn about safe usage standards.

Legal Framework

The supervision of medical devices by ZVA is governed by:

• Cabinet Regulation No. 461 ("Regulations Regarding Medical Devices") and Cabinet Regulation No. 582 ("Regulations Regarding In Vitro Diagnostic Medical Devices").
• Direct compliance and harmonization with the European Union's Medical Device Regulation (MDR) - Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) - Regulation (EU) 2017/746.