Tecnología Médica
Mapa TecMedTecnología Médica
Medical Devices Directorate Quarterly Performance Report for Q2 and Q3 2024-25
13/03/2025 -
The Medical Devices Directorate quarterly performance reports provides detailed metrics about the timeliness of pre-market medical devices review process against the performance service standards.
Guidance on terms and conditions for class II to IV medical devices
13/03/2025 -
Overview of regulatory authorities and guidance on T&Cs for medical device licences under Medical Device Regulations
Pre-market guidance for machine learning-enabled medical devices
13/03/2025 -
This document provides guidance to manufacturers who are submitting a new or amendment application for Class II, III and IV MLMD under the regulations.
Share your views: Consultation on the draft guidance on managing applications for medical device licences
13/03/2025 -
Consultation for draft guidance document on managing applications for medical device licenses.
Portable X-Ray Unit FDR Xair
11/03/2025 -
The residual risk information of the XD2000 provided was not sufficient. There is the potential defectiveness for users to be exposed to unnecessary radiation by unintended handheld use. The users...
ANMAT advierte sobre producto médico sutura marca ARTHREX falsificada
11/03/2025 -
ANMAT informa que, mediante el Control de Mercado de rutina, se ha detectado la distribución de un producto médico falsificado - sutura Arthrex - identificado como "2mm, REF AR-7237...
Monterey AL AL Implant Inserter
11/03/2025 -
For the lots in scope of this assessment, there has been a trend of reports from the field that found there was the potential for the gold unlock button to separate from the inserter. Investigation...
AK 96 and AK 98 Dialysis Machines
18/02/2025 -
Baxter Healthcare Corporation (Baxter) is issuing an urgent medical device correction for the AK 96 and AK 98 dialysis machines with the self-care configuration listed below due to the potential for...
Single Use Guide Sheath Kit
18/02/2025 -
Olympus conducted an investigation into the Single Use Guide Sheath Kits after receiving complaints that the radiopaque tip of the guide sheath component fell off into the patient. Since July 2021,...
ACCOLADE™ and VISIONIST™ CRT-P Pacemakers
18/02/2025 -
Boston Scientific is initiating an advisory to provide information about a subset of pacemakers from the ACCOLADE™ family and VISIONIST™ CRT-Ps with an increased potential to initiate safety mode...
