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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DRAFT GUIDANCE DOCUMENTS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
FAQs BERKENAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN.pdf
( pdf, 154 KB )
(5797 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 )
(10333 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 )
(1767 downloads)
Popular
15 Oct 2025
pdf
FINAL GD Placement of HIV Self-test Kit in Malaysia Market 2nd Edition (2).pdf
( pdf, 341 KB )
(4252 downloads)
Popular
03 Feb 2025
pdf
FINAL GD Placement of HIV Self-test Kit in Malaysia Market 2nd Edition.pdf
( pdf, 341 KB )
(3037 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 )
(2361 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 )
(15864 downloads)
Popular
12 Sep 2025
Image
Flowchart 2023.JPG
( jpg, 49 KB )
(993 downloads)
Popular
22 Feb 2023
pdf
Flowchart 2025 New Application
( pdf, 109 KB )
(2147 downloads)
Popular
21 Jul 2025
pdf
Flowchart 2025 Renewal Classification
( pdf, 153 KB )
(464 downloads)
Popular
21 Jul 2025
pdf
Flowchart 2025 Renewal Classification
( pdf, 94 KB )
(2692 downloads)
Popular
23 Jul 2025
pdf
Funding Opportunities for Medical Device Industry in Malaysia.pdf
( pdf, 492 KB )
(4404 downloads)
Popular
08 Nov 2024
pdf
GD APPLICATION FOR CONFIRMATION STATUS OF OBSOLETE AND DISCONTINUED MD FIRST EDITION
( pdf, 395 KB )
(2013 downloads)
Popular
30 Mar 2026
pdf
GD DEFINITION OF MEDICAL DEVICE 2ND EDITION
( pdf, 1.80 MB )
(3141 downloads)
Popular
30 Mar 2026
pdf
GD of Product Classification 3rd Ver 2024.pdf
( pdf, 370 KB )
(7924 downloads)
Popular
30 Jul 2024
pdf
GD of Product Classification 4th Ver 2025
( pdf, 289 KB )
(2440 downloads)
Popular
21 Jul 2025
pdf
GD of Product Classification 5th Ver 2025
( pdf, 373 KB )
(2722 downloads)
Popular
11 Nov 2025
pdf
GD of Product Classification 5th Ver 2025
( pdf, 373 KB )
(4274 downloads)
Popular
16 Dec 2025
pdf
GD of Product Classification Second Vers 2023.pdf
( pdf, 596 KB )
(7436 downloads)
Popular
22 Feb 2023
pdf
GD PLACEMENT OF HIVST IN MALAYSIA MARKET FIRST EDITION.pdf
( pdf, 630 KB )
(3969 downloads)
Popular
28 Aug 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
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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