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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DRAFT GUIDANCE DOCUMENTS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
Image
Awareness Program on Medical Device for Healthcare
Career
MeDC@St
Guideline Documents
GUIDANCE DOCUMENTS
CAB & Establishment
Regulation
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Forms
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Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
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UKK
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- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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Contoh Kategori Docman
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
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pdf
Teks Perutusan YAB PM PENJANA 05062020
( pdf, 153 KB )
(3626 downloads)
Popular
09 Jun 2020
document
Template for list of Questions for Consultation with MDA
( docx, 26 KB )
(2435 downloads)
Popular
28 Apr 2022
document
Template for list of questions for consultation.docx
( docx, 103 KB )
(1009 downloads)
Popular
04 Apr 2023
document
TEMPLATE FOR LOA.docx
( docx, 41 KB )
(825 downloads)
Popular
03 Mar 2025
pdf
Training 1 Training on Compliance with Licensing Requirements - TRAINING PACKAGE MDA (MDA).pdf
( pdf, 5.19 MB )
(650 downloads)
Popular
27 Feb 2025
pdf
TRAINING 6 TRAINING ON MEDICAL DEVICE LABELLING AND ADVERTISEMENT REQUIREMENTS
( pdf, 1.31 MB )
(1747 downloads)
Popular
30 May 2025
pdf
TRAINING 7 TRAINING ON FUNDAMENTAL OF SOFTWARE AS MEDICAL DEVICE (SaMd)
( pdf, 1.07 MB )
(963 downloads)
Popular
10 Jun 2025
pdf
Training Calendar 2025 (Updated 13.5) - TRAINING PACKAGE MDA (MDA).pdf
( pdf, 828 KB )
(1969 downloads)
Popular
14 May 2025
document
UPDATED BORANG ULASAN UMUM PEMBANGUNAN DOKUMEN PANDUAN GD EXPORT ONLY.docx
( docx, 38 KB )
(336 downloads)
Popular
28 Apr 2025
pdf
UPDATED DRAFT PUBLIC COMMENT GD EXPORT ONLY MEDICAL DEVICE SECOND EDITION.pdf
( pdf, 369 KB )
(924 downloads)
Popular
28 Apr 2025
pdf
Workshop November 2022 (Poster)
( pdf, 1.01 MB )
(2981 downloads)
Popular
05 Sep 2022
pdf
[20250612] Harmonised Borderline Products in ASEAN
( pdf, 1.28 MB )
(1915 downloads)
Popular
13 Jun 2025
pdf
[20250612] Harmonised Classification of Medical Devices in ASEAN
( pdf, 1.28 MB )
(2224 downloads)
Popular
13 Jun 2025
pdf
[ANNOUNCEMENT] IMPLEMENTATION OF MDA-CAB WORKSHOP 2024 OUTCOMES.pdf
( pdf, 116 KB )
(2330 downloads)
Popular
03 Jul 2024
pdf
[ANNOUNCEMENT] IMPLEMENTATION OF MDA-CAB WORKSHOP 2024 OUTCOMES.pdf
( pdf, 116 KB )
(204 downloads)
Popular
03 Jul 2024
pdf
[ANNOUNCEMENT] IMPLEMENTATION OF MDA-CAB WORKSHOP 2024 OUTCOMES.pdf
( pdf, 116 KB )
(177 downloads)
Popular
03 Jul 2024
pdf
[ANNOUNCEMENT] IMPLEMENTATION OF MDA-CAB WORKSHOP 2024 OUTCOMES
( pdf, 116 KB )
(294 downloads)
Popular
03 Jul 2024
pdf
[WEBSITE] CAB PROFICIENCY TRAININGS SANCTIONED BY MDA [4 TO 7 SEPTEMBER 2023].pdf
( pdf, 143 KB )
(1343 downloads)
Popular
25 Jul 2023
pdf
_MDA CORE TRAINING LIST 2024
( pdf, 3.57 MB )
(1239 downloads)
Popular
25 Apr 2024
pdf
_MDA CORE TRAINING LIST 2024 (Latest .pdf
( pdf, 7.47 MB )
(1564 downloads)
Popular
18 Jan 2024
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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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