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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DRAFT GUIDANCE DOCUMENTS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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INFOGRAPHIC
Pelan Anti Rasuah
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Date
pdf
Examples and Situations of Personal Use Medical Device
( pdf, 80 KB )
(1382 downloads)
Popular
15 Dec 2025
pdf
Exemption Order 2024 (1)
( pdf, 450 KB )
(544 downloads)
Popular
11 May 2026
pdf
FA5.pdf
( pdf, 5.36 MB )
(6417 downloads)
Popular
22 Nov 2024
pdf
Faq reregistration 20220602
( pdf, 110 KB )
(3535 downloads)
Popular
03 Jun 2022
pdf
FAQ.pdf
( pdf, 115 KB )
(7362 downloads)
Popular
21 Feb 2024
pdf
FAQs BERKENAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN.pdf
( pdf, 154 KB )
(6126 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 )
(11781 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 )
(1899 downloads)
Popular
15 Oct 2025
pdf
FINAL GD LABELLING REQUIREMENTS FOR MEDICAL DEVICE 7TH EDITION
( pdf, 393 KB )
(2220 downloads)
Popular
22 May 2026
pdf
FINAL GD Placement of HIV Self-test Kit in Malaysia Market 2nd Edition (2).pdf
( pdf, 341 KB )
(4702 downloads)
Popular
03 Feb 2025
pdf
FINAL GD Placement of HIV Self-test Kit in Malaysia Market 2nd Edition.pdf
( pdf, 341 KB )
(3303 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 )
(2641 downloads)
Popular
13 Oct 2025
pdf
FINAL Medical Device Registration Submission Guide For Conformity Assessment By Way Of Verification Process And Submission Of Application in MeDC@St Second Edition
( pdf, 480 KB )
(18553 downloads)
Popular
12 Sep 2025
Image
Flowchart 2023.JPG
( jpg, 49 KB )
(1062 downloads)
Popular
22 Feb 2023
pdf
Flowchart 2025 New Application
( pdf, 109 KB )
(2284 downloads)
Popular
21 Jul 2025
pdf
Flowchart 2025 Renewal Classification
( pdf, 153 KB )
(519 downloads)
Popular
21 Jul 2025
pdf
Flowchart 2025 Renewal Classification
( pdf, 94 KB )
(3091 downloads)
Popular
23 Jul 2025
pdf
Funding Opportunities for Medical Device Industry in Malaysia.pdf
( pdf, 492 KB )
(4906 downloads)
Popular
08 Nov 2024
pdf
GD APPLICATION FOR CONFIRMATION STATUS OF OBSOLETE AND DISCONTINUED MD FIRST EDITION
( pdf, 395 KB )
(2756 downloads)
Popular
30 Mar 2026
pdf
GD DEFINITION OF MEDICAL DEVICE 2ND EDITION
( pdf, 1.80 MB )
(4567 downloads)
Popular
30 Mar 2026
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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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