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MEDICAL DEVICE (EXEMPTION) ORDER 2016
Keputusan Tender/Sebut Harga
Frequently Asked Questions (FAQ)
MEDICAL DEVICE (EXEMPTION) ORDER 2015
DRAFT GUIDANCE DOCUMENTS
Seminar Bersama Industri Peranti Perubatan 2015
Seminar on Medical Device Competency
GLP
Prosedur dan Borang
- Borang
- Prosedur
Surat Pekeliling PBPP / MDA's Circular Letter
- Surat Pekeliling PBPP
- MDA's Circular Letter
ICT (for MDA's staff only)
Seminar on Implementation of Act 737
Training for Conformity Assessment Body (CAB)
Tawaran Tender/Sebut Harga
- Sebut Harga MDASH042018 Sistem Maklum Balas
- Sebut Harga MDASH052018 Portal
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Awareness Program on Medical Device for Healthcare
Career
MeDC@St
Guideline Documents
GUIDANCE DOCUMENTS
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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pdf
Clinical Investigational Plan (CIP).pdf
( pdf, 197 KB )
(5418 downloads)
Popular
05 Apr 2023
pdf
Compilation of Questions & Answers Related to IVD Issues.pdf
( pdf, 186 KB )
(314 downloads)
Popular
08 Aug 2024
pdf
Compilation of Questions & Answers Related to IVD Issues.pdf
( pdf, 186 KB )
(1331 downloads)
Popular
08 Aug 2024
document
Consultancy Request Form (Non-Package) (3).docx
( docx, 104 KB )
(3611 downloads)
Popular
21 Aug 2023
document
Consultancy Request Form (Non-Package) - LUQMAN HAFIFI BIN CHE YUSSOF (MDA).docx
( docx, 104 KB )
(356 downloads)
Popular
21 Aug 2023
document
Consultancy Request Form (Non-Package).docx
( docx, 104 KB )
(766 downloads)
Popular
02 Aug 2023
document
Consultancy Request Form (Package) (3).docx
( docx, 470 KB )
(3865 downloads)
Popular
21 Aug 2023
document
Consultancy Request Form (Package) - LUQMAN HAFIFI BIN CHE YUSSOF (MDA).docx
( docx, 470 KB )
(306 downloads)
Popular
21 Aug 2023
document
Consultancy Request Form (Package).docx
( docx, 470 KB )
(878 downloads)
Popular
02 Aug 2023
pdf
Data manufacturer - Copy of Sheet1.pdf
( pdf, 1.24 MB )
(1025 downloads)
Popular
14 Mar 2025
pdf
DECISION FROM MESYUARAT JAWATANKUASA TEKNIKAL PENDAFTARAN UMUM REQUIREMENTS ON QMS AND TRACEABILITY FORM (2).pdf
( pdf, 13 KB )
(3160 downloads)
Popular
07 Aug 2023
pdf
DECISION FROM MESYUARAT JAWATANKUASA TEKNIKAL PENDAFTARAN UMUM REQUIREMENTS ON QMS AND TRACEABILITY FORM.pdf
( pdf, 13 KB )
(844 downloads)
Popular
25 Jul 2023
pdf
Dispute Class Risk Form v1
( pdf, 62 KB )
(155 downloads)
Popular
26 May 2025
pdf
Draf Dokumen Panduan Wearable Medical Device-Public Comment.pdf
( pdf, 263 KB )
(764 downloads)
Popular
21 Aug 2023
pdf
Draf Dokumen Panduan Wearable Medical Device-Public Comment.pdf
( pdf, 263 KB )
(1003 downloads)
Popular
21 Aug 2023
pdf
Draf GD Importation of Medical Device for Personal Use-Public Comment.pdf
( pdf, 334 KB )
(2189 downloads)
Popular
31 Jul 2023
pdf
DRAFT PUBLIC COMMENT GD EXPORT ONLY MEDICAL DEVICE SECOND EDITION - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).pdf
( pdf, 369 KB )
(76 downloads)
28 Apr 2025
pdf
Draft Public Comment GD Importation of Medical Device for Personal Use Second Edition - UPDATED 2025.pdf
( pdf, 305 KB )
(1400 downloads)
Popular
22 Jan 2025
document
Essential Requirement Special Access.docx
( docx, 41 KB )
(471 downloads)
Popular
01 Sep 2023
pdf
Essential Requirement Special Access.pdf
( pdf, 95 KB )
(4390 downloads)
Popular
08 Sep 2023
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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
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
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