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Fifth Edition Guideline for Medical Device-Drug and Drug-Medical Device Combination Product
11 January 2023
8248
PUBLIC COMMENT DRAFT GUIDANCE DOCUMENT REQUIREMENTS FOR APPLICATION OF CERTIFICATE OF FREE SALE (CFS), MANUFACTURING CERTIFICATE (MC) AND CERTIFICATE OF FREE SALE FOR EXPORT ONLY (CFS EO) MEDICAL DEVICES
23 December 2022
8114
REGISTRATION OF COVID-19 TEST KITS THAT HAVE BEEN APPLIED VIA CONDITIONAL APPROVAL AND SPECIAL ACCESS
16 December 2022
7507
How Do I Keep Up with The Latest Regulatory Information and Activities? - Medical Device Authority-Regulatory Information
14 December 2022
11632
PINDAAN TERKINI SYARAT-SYARAT LESEN
13 December 2022
10534
FOURTH EDITION GUIDANCE DOCUMENT MDA/GD/0020: CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICE
21 November 2022
11891
SIXTH EDITION GUIDANCE DOCUMENT MDA/GD/0026: REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES
21 November 2022
11616
TRAINING FOR RE-REGISTRATION FOR CAB AUDITORS AND TECHNICAL PERSONNEL UNDER ACT 737 (COMPLIANCE TO THE CONFORMITY ASSESSMENT BODY REGISTRATION REQUIREMENTS)
01 November 2022
13166
TRAINING BY THE MEDICAL DEVICE AUTHORITY ON GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICE (GDPMD) FOR LEAD AUDITOR
31 October 2022
16130
PUBLIC COMMENT DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT NOTIFICATION FOR CUSTOM-MADE MEDICAL DEVICE
31 October 2022
8133
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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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