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FIELD CORRECTIVE ACTION (FCA) LISTING FOR SEPTEMBER 2022
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FIELD CORRECTIVE ACTION (FCA) LISTING FOR AUGUST 2022
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FIELD CORRECTIVE ACTION (FCA) LISTING FOR JULY 2022
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FIELD CORRECTIVE ACTION (FCA) LISTING FOR MARCH 2022
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December 2021 : Notification of Initiation of FSCA (MY-FSN-CPS-2020-091) - version 8 Elecsys CA 19-9 : Non-reproducible elevated results with certain reagent lots on cobas e 801.
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December 2021 : FCA Notification 2021-003M _Olympus Evis Exera II Duodenovideoscope TJF-Q180V : Supplemental material for inspection.
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December 2021 : Field Correction Action Report - DELFIA® Xpress_R2021004 : Potential for decreased analyte measurement with DELFIA® Xpress hAFP, Free hCGß, PAPP-A, and hCG kits
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Page 4 of 16
Home
Introduction
Background
Vision, Mission & Core Value
Functions
Organisation Chart
Code of Ethics and Conduct
Board of Directors
Top Management Team of MDA
Malaysian Leadership
Former CEO of MDA
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
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)
Annual Report
Customer Satisfaction Survey
Customer Satisfaction Survey Result
Customer Satisfaction Survey Report
Integrity Information
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