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October 2021 : Abbott Assurity and Endurity pacemaker (our ref. FA-Q121-CRM-2) : For a subset of Assurity and Endurity Pacemakers
Hits: 5013
October 2021 : Field Safety Notice AX067/21/S : Missing regular reboot of the system may result in frozen vital signs
Hits: 7900
September 2021 : Urgent Product Correction FA29SEP2021 ARCHITECT ARCHITECT System software v9.45/9.50
Hits: 3435
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: 6450
September 2021 : 2021-IGT-PUN-010 (FCO72300030) - Firmware Upgrade for Intuis System
Hits: 3672
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: 10135
September 2021 : Field-Corrective Action Notification 20001103083 : Digital Linear Accelerator - For service user: precautions to be taken when handling diode D1
Hits: 4344
September 2021 : Corrective action reporting for FMI 32081 : Mounting issue for LullabyTMResus Plus/Prime dovetailmounts ontoLullabyTMWarmer side rails
Hits: 3339
September 2021 : Product Field Corrective Action PR 2795031 - Stryker NAV3/NAV3i Platforms : Microsoft Windows Print Spooler Vulnerabilities
Hits: 3255
September 2021 : Notification of Initiation of FSCA (MY-FSN-RDS-Molecular Lab-2021-011) - cobas® EGFR Mutation Test v2: Potential for False Mutation Detected results for exon20 Insertion.
Hits: 8905
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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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