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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DRAFT GUIDANCE DOCUMENTS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
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MeDC@St
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GUIDANCE DOCUMENTS
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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pdf
Draf Dokumen Panduan Wearable Medical Device-Public Comment.pdf
( pdf, 263 KB )
(1653 downloads)
Popular
21 Aug 2023
pdf
Draf Dokumen Panduan Wearable Medical Device-Public Comment.pdf
( pdf, 263 KB )
(1236 downloads)
Popular
21 Aug 2023
pdf
Draf GD Importation of Medical Device for Personal Use-Public Comment.pdf
( pdf, 334 KB )
(3079 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 )
(341 downloads)
Popular
28 Apr 2025
pdf
Draft Public Comment GD Importation of Medical Device for Personal Use Second Edition - UPDATED 2025.pdf
( pdf, 305 KB )
(4355 downloads)
Popular
22 Jan 2025
pdf
EN Surat Pekeliling MDA Bil 2 (2025)
( pdf, 2.45 MB )
(990 downloads)
Popular
15 Oct 2025
pdf
English CARTA ORGANISASI MDA September 2025
( pdf, 208 KB )
(748 downloads)
Popular
09 Sep 2025
pdf
ENGLISH PDF CHART ORGANISATION 4 AUG 2025
( pdf, 208 KB )
(839 downloads)
Popular
04 Aug 2025
document
Essential Requirement Special Access.docx
( docx, 41 KB )
(719 downloads)
Popular
01 Sep 2023
pdf
Essential Requirement Special Access.pdf
( pdf, 95 KB )
(6448 downloads)
Popular
08 Sep 2023
pdf
Examples and Situations of Personal Use Medical Device
( pdf, 80 KB )
(763 downloads)
Popular
15 Dec 2025
pdf
FA5.pdf
( pdf, 5.36 MB )
(6167 downloads)
Popular
22 Nov 2024
pdf
Faq reregistration 20220602
( pdf, 110 KB )
(3318 downloads)
Popular
03 Jun 2022
pdf
FAQ.pdf
( pdf, 115 KB )
(6762 downloads)
Popular
21 Feb 2024
pdf
FAQs BERKENAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN.pdf
( pdf, 154 KB )
(5309 downloads)
Popular
09 Sep 2024
pdf
FINAL DRAFT GD CONFORMITY ASSESSMENT BODY (CAB) GUIDE FOR CONDUCTING CONFORMITY ASSESSMENT BY WAY OF VERIFICATION FIRST EDITION
( pdf, 869 KB )
(8485 downloads)
Popular
12 Sep 2025
pdf
FINAL DRAFT GD CONFORMITY ASSESSMENT BODY (CAB) GUIDE FOR CONDUCTING CONFORMITY ASSESSMENT BY WAY OF VERIFICATION FIRST EDITION (2)
( pdf, 869 KB )
(1566 downloads)
Popular
15 Oct 2025
pdf
FINAL GD Placement of HIV Self-test Kit in Malaysia Market 2nd Edition (2).pdf
( pdf, 341 KB )
(3606 downloads)
Popular
03 Feb 2025
pdf
FINAL GD Placement of HIV Self-test Kit in Malaysia Market 2nd Edition.pdf
( pdf, 341 KB )
(2719 downloads)
Popular
31 Jan 2025
pdf
FINAL Guidance Documen on Submission Guide For Conformity Assessment By Way Of Verification Process And Submission Of Application in MeDC@St
( pdf, 480 KB )
(2002 downloads)
Popular
13 Oct 2025
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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
General Directions
Circular Letter
Guidance Document
Guideline
Standard
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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