INFARMED: Overview of Portugal's Medical Device Regulatory Body

Overview of INFARMED, I.P.

INFARMED - National Authority of Medicines and Health Products, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.) is a government agency under the Portuguese Ministry of Health. It serves as the national competent authority for the evaluation, authorization, regulation, and control of human medicines and health products, including medical devices and cosmetics.

Core Role in Medical Devices

INFARMED's primary mission is to ensure that medical devices on the Portuguese market meet high standards of quality, safety, and performance to protect public health.

Key Responsibilities

1. Implementation of EU Regulations: Ensures the national application of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
2. Market Surveillance and Vigilance: Manages the National Vigilance System for Medical Devices to monitor incidents, assess risks, and implement safety corrective actions.
3. Registration and Notification: Oversees the registration of medical devices and the notification of economic operators (manufacturers, authorized representatives, and distributors).
4. Clinical Investigations: Evaluates and authorizes clinical investigations involving medical devices in Portugal.
5. Advertising Regulation: Supervises and enforces rules regarding the advertising and promotion of medical devices to both healthcare professionals and the public.
6. Inspections and Licensing: Conducts audits and inspections of manufacturers and wholesalers to ensure compliance with Good Manufacturing and Distribution Practices.

Contact Information

• Official Website: www.infarmed.pt
• Supervising Entity: Ministry of Health, Portugal