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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DRAFT GUIDANCE DOCUMENTS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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Regulation
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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pdf
PROGRAM 8 POST-MARKET .pdf
( pdf, 3.26 MB )
(601 downloads)
Popular
12 Jun 2024
pdf
PROGRAM 9 HANDS- ON (MEDCREST) POST-MARKET .pdf
( pdf, 11.53 MB )
(725 downloads)
Popular
12 Jun 2024
pdf
PROGRAM 9 IN DEPTH TRAINING ON IN-VITRO DIAGNOSTIC .pdf
( pdf, 665 KB )
(1241 downloads)
Popular
12 Jun 2024
pdf
PUA 330 2025 (2)
( pdf, 178 KB )
(7541 downloads)
Popular
14 Oct 2025
pdf
PUA10 MEDICAL DEVICE (DESIGNATED MEDICAL DEVICE) ORDER 2026
( pdf, 362 KB )
(4544 downloads)
Popular
13 Jan 2026
pdf
Public Comment GD Application for Confirmation Status of Orphaned Medical Device docx ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA)
( pdf, 455 KB )
(1998 downloads)
Popular
16 Oct 2025
pdf
Public Comment GD Change Management for Registered Medical Device
( pdf, 1.73 MB )
(4006 downloads)
Popular
03 Dec 2025
pdf
PUBLIC COMMENT GD DEFINITION OF MEDICAL DEVICE SECOND EDITION
( pdf, 246 KB )
(3693 downloads)
Popular
04 Dec 2025
pdf
PUBLIC COMMENT GD LABELLING REQUIREMENTS FOR MEDICAL DEVICE DRAFT 7TH EDITION docx
( pdf, 368 KB )
(3755 downloads)
Popular
15 Oct 2025
pdf
PUBLIC COMMENT GD OBSOLETE AND DISCONTINUED FIRST EDITION docx
( pdf, 673 KB )
(2139 downloads)
Popular
16 Oct 2025
document
Regulatory Feedback Form - SABAH.docx
( docx, 23 KB )
(884 downloads)
Popular
11 Sep 2023
document
Regulatory Feedback Form 1512024 - SARAWAK.docx
( docx, 23 KB )
(3139 downloads)
Popular
15 Jan 2024
pdf
RINGKASAN EKSEKUTIF PSP MDA 2021-2025_25052023
( pdf, 47.17 MB )
(1481 downloads)
Popular
08 Jun 2023
pdf
RISK.pdf
( pdf, 208 KB )
(3503 downloads)
Popular
12 Jan 2025
pdf
Schedule Planner 2025.pdf
( pdf, 216 KB )
(3230 downloads)
Popular
12 Jan 2025
pdf
Seminar Kawalan Pengiklanan edit
( pdf, 676 KB )
(3383 downloads)
Popular
12 Sep 2022
pdf
Seminar Kawalan Pengiklanan'
( pdf, 676 KB )
(1531 downloads)
Popular
12 Sep 2022
pdf
Seminar Putrajaya 2022 (Poster)
( pdf )
(1844 downloads)
Popular
07 Sep 2022
document
Special Access Portal 7 5 2026 (6)
( docx, 3.42 MB )
(9 downloads)
New
11 May 2026
pdf
Statistic Year 2024.pdf
( pdf, 242 KB )
(3059 downloads)
Popular
04 Mar 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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