Our Hotline
+603 - 8230 0300
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
Search
fas fa-search
Home
Alert
Filters
Title Filter
Display #
5
10
15
20
25
30
50
100
All
Filter
Title
Hits
December 2021 : FSN : QIAcube Connect MDx Instrument REF 9003070 - issue with the text contained within several protocols which run on the QIAcube® Connect MDx instrument.
Hits: 11360
December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.
Hits: 4336
December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data
Hits: 4582
December 2021 : Initial Reporting FA 21072 : Field Safety Notification on AU/DxC AU Magnesium - IFU update due to lipemic interference for the Magnesium serum application failed to meet the performance specification.
Hits: 7274
November 2021 : Customer Safety Information (CSI) for Field Safety Corrective Action FCA AX077/21/S | FSN AX078/21/S, AX081/21/S : ComboBox does no longer login automatically after several reboots. Calculation of Cardiac Output (Thermodilution method) on
Hits: 6988
November 2021 : FSN-2021-013 DR0155M Thermo Scientific™ Campylobacter Test Kit: Auto-agglutinating in all the test latexes with + to ++ reactions.
Hits: 11915
November 2021 : FCA Notification - iDesign Advanced Wavescan Studio System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Hits: 8914
November 2021 : FCA Notification - CATALYS™ Precision Laser System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Hits: 12325
November 2021 : Initial Report for CR-2021-IGT-BST-011 (FCO72200484) - Leakage of cooling fluid of flat detector in the R-cabinet ®
Hits: 12123
November 2021 : FA1197 Abre Venous Self-expanding Stent System IFU Update
Hits: 4752
1
2
3
4
5
6
7
8
9
10
Page 5 of 16
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
×