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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.
4934
Julai 2021 : Preliminary Report FCA 2104 : Automated Blood Coagulation Analyzer CS-1600 - CS-1600/1300 EMC (Electromagnetic Compatibility) compliance issue
5005
Julai 2021 : Field Corrective Action Notification CA310-0018 : DRYPRO SIGMA - Procedure for replacing defective cable between MCS and ET motor
5584
Julai 2021 : FSCA 5183 - BioFire® - Pneumonia Panel - Increased Risk of False Negative
11439
Julai 2021 : FSCA Notice SCA-21-001 - Fabian Ventilator : Power Board Failures due to Component Electrical Overstress
4726
Julai 2021 : REF-EN 01698 INTERCEPT Blood System for Plasma, Processing Set for Plasma : Mislabelling in the Instructions for Use and product labels
8232
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
7771
Jun 2021 : Initial Report FA2020-04 NGP Retainer Pump Ring Issue Notification - 6 Monthly Reminder (3rd Round)
4215
Jun 2021 : Field Safety Corrective Action (MY-FSN-RDS-CoreLab-2021-009) : cobas u pack (INT) - Updated Urine Interference Claims.
5987
Jun 2021 : URGENT – FIELD SAFETY NOTICE FSN-SUZ-001-2021 Nimbus 4 & Nimbus Professional mattress – risk of over-inflation
8186
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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
Integrity Unit
Internal Audit Unit
International and Industry Relations Division
Pre-Market Control Division
Policy and Strategic Planning Division
Post Market Division
Enforcement Division
Management Services Division
Finance Division
Corporate Communication Division
Legal Division
Digital and Information Technology Division
Secretarial Division
Regulatory Transformation 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
Training Academy (COE)
Speakers
Registration
Licensing
Comformity Assessment Body (CAB)
Syllabus
Registration
Licensing
Comformity Assessment Body (CAB)
Training Schedule
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