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Julai 2021 : Field Safety Notification FA-000609 on Kaluza C Flow Cytometry Software : Software anomalies in Kaluza C that may lead to the generation of erroneous results.
Hits: 7017
Julai 2021 : Notification of Initiation of FSCA (SB_RDC_2021_03) : Important information about open vials of Accu-Chek®Performa test strips
Hits: 9736
Julai 2021 : FSN Maquet Flow-I Anesthesia System FSN0221 : Absorber lift spring exchange
Hits: 9028
Julai 2021 : FIELD SAFETY NOTICE 2021-004M Software update Notification for CV-1500 and resumption of use with EZ1500 series endoscopes
Hits: 3287
Julai 2021 : Field Corrective Action Notification 200-06-103-090 : Digital Accelerator - CITB external interlock check
Hits: 10813
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: 3841
Julai 2021 : Preliminary Report FCA 2104 : Automated Blood Coagulation Analyzer CS-1600 - CS-1600/1300 EMC (Electromagnetic Compatibility) compliance issue
Hits: 3726
Julai 2021 : Field Corrective Action Notification CA310-0018 : DRYPRO SIGMA - Procedure for replacing defective cable between MCS and ET motor
Hits: 4399
Julai 2021 : FSCA 5183 - BioFire® - Pneumonia Panel - Increased Risk of False Negative
Hits: 9831
Julai 2021 : FSCA Notice SCA-21-001 - Fabian Ventilator : Power Board Failures due to Component Electrical Overstress
Hits: 3443
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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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