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Julai 2021 : Field Corrective Action Notification 200-06-103-090 : Digital Accelerator - CITB external interlock check
Hits: 11040
Julai 2021 : Corrective action reporting for FMI 15145 : Potential early Coin Cell Battery depletion on OEC Elite systems manufactured on or after January 2019 and all OEC 3D mobile C-Arm systems.
Hits: 4076
Julai 2021 : Preliminary Report FCA 2104 : Automated Blood Coagulation Analyzer CS-1600 - CS-1600/1300 EMC (Electromagnetic Compatibility) compliance issue
Hits: 3970
Julai 2021 : Field Corrective Action Notification CA310-0018 : DRYPRO SIGMA - Procedure for replacing defective cable between MCS and ET motor
Hits: 4644
Julai 2021 : FSCA 5183 - BioFire® - Pneumonia Panel - Increased Risk of False Negative
Hits: 10197
Julai 2021 : FSCA Notice SCA-21-001 - Fabian Ventilator : Power Board Failures due to Component Electrical Overstress
Hits: 3695
Julai 2021 : REF-EN 01698 INTERCEPT Blood System for Plasma, Processing Set for Plasma : Mislabelling in the Instructions for Use and product labels
Hits: 7271
Julai 2021 : Corrective action reporting for FMI 60978 : Incorrect Image Annotation and/or Flipped Images as a result of Inadvertently Changing the PrescribedPatient Orientation. SIGNA Premier, Signa Pioneer, SIGNA Architect, Discovery MR750w 3.0T, Discov
Hits: 6948
Jun 2021 : Initial Report FA2020-04 NGP Retainer Pump Ring Issue Notification - 6 Monthly Reminder (3rd Round)
Hits: 3270
Jun 2021 : Field Safety Corrective Action (MY-FSN-RDS-CoreLab-2021-009) : cobas u pack (INT) - Updated Urine Interference Claims.
Hits: 5096
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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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