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Ogos 2021 : Urgent Medical Device Correction FA-2021-05-001-SKF-004 Potential risk of probe tip overheating associated with Welch Allyn® Braun® ThermoScan® PRO 6000 Ear Thermometer.
Hits: 9989
Ogos 2021 : Urgent Field Safety Notice 2021-001 : Duoderm CGF & Extra-Thin Dressings - Open seal where packaging layers are not sealed together completely, leaving partial or fully open seal after manufacturing.
Hits: 6716
Ogos 2021 : Corrective action reporting for FMI 34120 : Flow Sensors with Potentially Damaged Tubesin GEHealthcare/ Datex-Ohmeda Anesthesia Machines.
Hits: 8042
Ogos 2021 : FCA Notification - Olympus Forceps/Irrigation Plug (Isolated Type) MAJ-891 : Reprocessing Recommendations for Forceps/Irrigation Plug (Isolated Type) MAJ-891
Hits: 3502
Julai 2021 : Aquastop valve replacement for Heinemann MODULA series ENT Treatment Units (Easmed Internal No. MY-CAPA-2021-03 / MAL-FSCA-2021-01, Heinemann No. FSCA-AQ-HM-10052021_Rev1.0_EN)
Hits: 4007
Julai 2021 : Initial Report - FY2020-02 MiniMed Paradigm Series Insulin Pumps Cybersecurity Concerns V3 : Potential security vulnerability
Hits: 3480
Julai 2021 : Product Correction FA26JUL2021 . Urgent ‐ Immediate Action Required : Alinity ci‐series System Control Module (SCM) - Potential performance issues for the Alinity ci‐series Software version 3.2.3 and earlier
Hits: 6082
Julai 2021 : Notification on Initial Report for 2021-CC-SRC-007 (2021-07-A) - Trilogy EV300, Trilogy Evo and Trilogy Evo O2 Software Issue
Hits: 3100
Julai 2021 : FSCA Notifications - 062 CN POC 21-022 RAPIDLab 1200 Lactate Sensor : Potential Lactate Signal Carryover on RAPIDLab 1200 Lactate Sensors
Hits: 4255
Julai 2021 : Notification on Initial Report for FCO79500549 - EPIQ Swivel Lock Failure
Hits: 3734
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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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