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Ogos 2021 : Field Corrective Action CT018/21/S : SOMATOM GO.TOP - Remotely software update due to scanning workflow interruptions and unexpected user notifications
Hits: 4322
Ogos 2021 : Initial Report for CR-2021-PD-US-005 (FCO79500535) - Philips EPIQ & Affiniti Ultrasound Systems Lock Up Issue
Hits: 4096
Ogos 2021 : FCA Notification 2021-002M - Endoscope Label on Front Door of Olympus Endoscope ReprocessorOER-AW
Hits: 3556
Ogos 2021 : Initial Report for CR-2021-PD-DXR-001 (FCO 70900050) - CombiDiagnost R90 - Software Package 1.1.1&1.1.2
Hits: 3210
Ogos 2021 : Initial Report for CR-2021-PD-DXR-001 (FCO70900051) - Software update for Kv-Ma Lockin issue for CombiDiagnost R90 1.0
Hits: 3789
Ogos 2021 : Urgent MEDICAL DEVICE FIELD CORRECTION (Event ID: Cordis2020720) : Cordis SUPER TORQUE®MB Angiographic Catheter - Correction related to labeling of a specific subset of angiographic catheters
Hits: 11419
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: 10390
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: 7095
Ogos 2021 : Corrective action reporting for FMI 34120 : Flow Sensors with Potentially Damaged Tubesin GEHealthcare/ Datex-Ohmeda Anesthesia Machines.
Hits: 8412
Ogos 2021 : FCA Notification - Olympus Forceps/Irrigation Plug (Isolated Type) MAJ-891 : Reprocessing Recommendations for Forceps/Irrigation Plug (Isolated Type) MAJ-891
Hits: 3749
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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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