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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DRAFT GUIDANCE DOCUMENTS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
CAB & Establishment
Regulation
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
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UKK
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pdf
GD LABELLING REQUIREMENTS FOR MEDICAL DEVICE 7TH EDITION
( pdf, 273 KB )
(1859 downloads)
Popular
15 May 2026
pdf
GD of Product Classification 3rd Ver 2024.pdf
( pdf, 370 KB )
(8041 downloads)
Popular
30 Jul 2024
pdf
GD of Product Classification 4th Ver 2025
( pdf, 289 KB )
(2636 downloads)
Popular
21 Jul 2025
pdf
GD of Product Classification 5th Ver 2025
( pdf, 373 KB )
(3264 downloads)
Popular
11 Nov 2025
pdf
GD of Product Classification 5th Ver 2025
( pdf, 373 KB )
(5270 downloads)
Popular
16 Dec 2025
pdf
GD of Product Classification Second Vers 2023.pdf
( pdf, 596 KB )
(7578 downloads)
Popular
22 Feb 2023
pdf
GD PLACEMENT OF HIVST IN MALAYSIA MARKET FIRST EDITION.pdf
( pdf, 630 KB )
(4061 downloads)
Popular
28 Aug 2023
pdf
GD PUBLIC COMMENT CFS, MC AND CFS EO.pdf
( pdf, 606 KB )
(3588 downloads)
Popular
23 Dec 2022
pdf
GD_Code of Advertisement COA 25 7 2023.pdf
( pdf, 374 KB )
(1290 downloads)
Popular
25 Jul 2023
pdf
GD_Code of Advertisement COA_8 April 2021_v2.1 (1).pdf
( pdf, 402 KB )
(3918 downloads)
Popular
19 Mar 2025
pdf
Guidance Document Change Management for Registered Medical Devices 1st Edition
( pdf, 1.73 MB )
(3307 downloads)
Popular
15 May 2026
pdf
GUIDANCE DOCUMENT CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICE 4TH EDITION_FINAL-Cat3 change.pdf
( pdf, 495 KB )
(11008 downloads)
Popular
21 Feb 2024
pdf
Guidance Document Importation of Medical Device for Re-export (IRE) First Edition (1).pdf
( pdf, 533 KB )
(7780 downloads)
Popular
13 Mar 2025
pdf
Guidance Document Importation of Medical Device for Re-export (IRE) First Edition.pdf
( pdf, 523 KB )
(1340 downloads)
Popular
11 Mar 2025
pdf
GUIDELINE CONDITIONAL APPROVAL FOR COVID 19 RTK SELF TEST 290721 v5 (1)
( pdf, 598 KB )
(4820 downloads)
Popular
03 Aug 2021
pdf
Guideline of Product Classification DRAFT 2 0 (without Annex B)
( pdf, 501 KB )
(5439 downloads)
Popular
09 Mar 2022
pdf
HANDS ON RCA AND CAPA TRAINING
( pdf, 1.97 MB )
(1166 downloads)
Popular
08 May 2026
pdf
Hands On Workshop
( pdf )
(4174 downloads)
Popular
18 Feb 2022
pdf
HEBAHAN MEDIA - KENYATAAN MEDIA PENCAPAIAN MDA 2023 - 2024.pdf
( pdf, 188 KB )
(1748 downloads)
Popular
10 Feb 2025
pdf
IKLAN COS W19.pdf
( pdf, 1001 KB )
(4583 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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