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October 2021 : Urgent Field Safety Notice FSCA260 : BIPOLAR CUP TRIAL HEAD - Update reprocessing of the Bipolar Cup trial head
Hits: 7689
October 2021 : FSCA LASW 21-01 Aptio Automation : Interface Module to the ADVIA®Centaur XP/XPT
Hits: 11362
October 2021 : DELFIA® Xpress Free hCGß kit : Potential for decreased analyte measurement withDELFIA® Xpress Free hCGßkits
Hits: 7344
October 2021 : Abbott Assurity and Endurity pacemaker (our ref. FA-Q121-CRM-2) : For a subset of Assurity and Endurity Pacemakers
Hits: 4529
October 2021 : Field Safety Notice AX067/21/S : Missing regular reboot of the system may result in frozen vital signs
Hits: 6928
September 2021 : Urgent Product Correction FA29SEP2021 ARCHITECT ARCHITECT System software v9.45/9.50
Hits: 3051
September 2021 : FSCA LASW 21-02 Aptio by Inpeco and FlexLab Automation : Aptio Automation Firmware (FW) for the ADVIA Centaur XP/XPT Interface Module may lead, in specific and rare cases, to an incorrect association of test result(s) to sample ID.
Hits: 5601
September 2021 : 2021-IGT-PUN-010 (FCO72300030) - Firmware Upgrade for Intuis System
Hits: 3252
September 2021 : FSCA ACHC 21-14 ADVIA and Atellica UCFP carryover : Falsely Depressed Enzymatic Hemoglobin A1c Results due to Reagent Carryover from the Urinary/Cerebrospinal Fluid Protein (UCFP) Assay.
Hits: 9170
September 2021 : Field-Corrective Action Notification 20001103083 : Digital Linear Accelerator - For service user: precautions to be taken when handling diode D1
Hits: 4008
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Home
Introduction
Background
Vision, Mission & Core Value
Functions
Contact Us
Organisation Chart
Code of Ethics and Conduct
Board of Directors
Top Management
Division
Chief Executive's Office
Corporate Communication Unit
Legal Unit
Integrity Unit
Secretarial Unit
Pre-Market Control Division
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Management and Service Unit
FAQ
Single License Policy Implementation
Registration, Licensing & Enforcement
Labelling of Medical Devices
Technical Evaluation
Contact Us
Customer Complaint Form
Customer Satisfaction Survey
Staff Directory
Documents
Legislation
Circular Letter
Guidance Document
Guideline
Standard
General Directions
Strategic Plan
Slide Presentation
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Customer Satisfaction Survey Result
Annual Report
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