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Julai 2021 : REF-EN 01698 INTERCEPT Blood System for Plasma, Processing Set for Plasma : Mislabelling in the Instructions for Use and product labels
Hits: 6871
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: 6594
Jun 2021 : Initial Report FA2020-04 NGP Retainer Pump Ring Issue Notification - 6 Monthly Reminder (3rd Round)
Hits: 3047
Jun 2021 : Field Safety Corrective Action (MY-FSN-RDS-CoreLab-2021-009) : cobas u pack (INT) - Updated Urine Interference Claims.
Hits: 4864
Jun 2021 : URGENT – FIELD SAFETY NOTICE FSN-SUZ-001-2021 Nimbus 4 & Nimbus Professional mattress – risk of over-inflation
Hits: 6934
Jun 2021 : Initial Report for 2021-05-A - Respironics Trilogy 100, Trilogy 200, V30, and A Series Device Models - Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission
Hits: 2799
Jun 2021 : [Important Product Correction Notification][TC2021-174] - VITROS Systems Inadvertently Configured to Use Expired Reagent
Hits: 3062
Jun 2021 : Field Safety Notice RC-21-0021 Software version 4.06 on STA R Max® - Potential rinsing anomaly of needles # 2 and # 3
Hits: 9217
Jun 2021 : Field Corrective Action_ArjoHuntleigh Indigo (accessory to Enterprise series bed): Indigo power cord might wear during use which could lead to its damage and sparks emission.
Hits: 2565
Jun 2021 : Initial Report for FCO86600059 - V60/V60 Plus Ventilator - Information Regarding High Flow Therapy Option
Hits: 8123
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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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