INFARMED
Circular Informativa
N.º 137/CD/100.20.200
Data: 21/09/2018
Novos Regulamentos de DM e DIV – orientações da Comissão Europeia para fabricantes
News & Trends
Procurar
Recentes
- EU HTA Regulation and EU Harmonised Assessment for Digital Medical Devices (including AI)
- Data Integrity Frequently Asked Questions (FAQ)
- Relatório Anual da Gestão da Disponibilidade de Medicamentos de 2024
- Bioanalytical Method Validation for Biomarkers
- MEDTECH AND DIGITAL HEALTH: A COMPREHENSIVE GUIDE TO MARKET ACCESS IN GERMANY.
- Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)
- EMA establishes regular procedure for scientific advice on certain high-risk medical devices
- MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies Revision 5 – February 2025