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November 2021 : FCA Notification - iDesign Advanced Wavescan Studio System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Hits: 8307
November 2021 : FCA Notification - CATALYS™ Precision Laser System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Hits: 11474
November 2021 : Initial Report for CR-2021-IGT-BST-011 (FCO72200484) - Leakage of cooling fluid of flat detector in the R-cabinet ®
Hits: 11688
November 2021 : FA1197 Abre Venous Self-expanding Stent System IFU Update
Hits: 4501
November 2021 : FSCA Notifications - 006 ASW 22-01 Atellica CH 930 Analyzer : Issues with setting Open Channel Assay parameters.
Hits: 3804
November 2021 : Field Corrective Action Report GLB143074 - Freelite® Human Lambda Free Kit (for use on the SPAPLUS®) : Imprecision at top of calibration curve
Hits: 12334
November 2021 : Corrective action reporting for FMI 73091 : Vscan Extend - Battery Depletion
Hits: 3794
November 2021 : FSCA Notice CAPA-HER-MD-21-002 - Surgical Microscope Leica Microscope M220 F12 : Additional Retention Fixture to secure M220 Optics Carrier
Hits: 4040
November 2021 : FA1204 9733763 & S9735585 Biopsy Depth Gauge Cycle View Inaccuracy Phase 1
Hits: 2971
November 2021 : Corrective action reporting for FMI 34122 : Carestation 750/750c Anesthesia Delivery Systems - After a specific sequence of actions, audible tone of "O2 supply pressure low" alarm will remain silenced until system reboot.
Hits: 6276
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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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