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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DRAFT GUIDANCE DOCUMENTS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
Image
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
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UKK
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pdf
PUBLIC COMMENT GD LABELLING REQUIREMENTS FOR MEDICAL DEVICE DRAFT 7TH EDITION docx
( pdf, 368 KB )
(1693 downloads)
Popular
15 Oct 2025
pdf
PUBLIC COMMENT GD OBSOLETE AND DISCONTINUED FIRST EDITION docx
( pdf, 673 KB )
(947 downloads)
Popular
16 Oct 2025
document
Regulatory Feedback Form - SABAH.docx
( docx, 23 KB )
(676 downloads)
Popular
11 Sep 2023
document
Regulatory Feedback Form 1512024 - SARAWAK.docx
( docx, 23 KB )
(2647 downloads)
Popular
15 Jan 2024
pdf
RINGKASAN EKSEKUTIF PSP MDA 2021-2025_25052023
( pdf, 47.17 MB )
(1151 downloads)
Popular
08 Jun 2023
pdf
RISK.pdf
( pdf, 208 KB )
(1838 downloads)
Popular
12 Jan 2025
pdf
Schedule Planner 2025.pdf
( pdf, 216 KB )
(1717 downloads)
Popular
12 Jan 2025
pdf
Seminar Kawalan Pengiklanan edit
( pdf, 676 KB )
(2797 downloads)
Popular
12 Sep 2022
pdf
Seminar Kawalan Pengiklanan'
( pdf, 676 KB )
(1322 downloads)
Popular
12 Sep 2022
pdf
Seminar Putrajaya 2022 (Poster)
( pdf )
(1653 downloads)
Popular
07 Sep 2022
pdf
Statistic Year 2024.pdf
( pdf, 242 KB )
(1484 downloads)
Popular
04 Mar 2025
pdf
SUBMISSION GUIDE FOR NEW PC .pdf
( pdf, 3.85 MB )
(3623 downloads)
Popular
30 Jul 2024
pdf
SUBMISSION GUIDE FOR NEW PC jun 2025
( pdf, 3.83 MB )
(1299 downloads)
Popular
21 Jul 2025
pdf
SUBMISSION GUIDE FOR RENEWAL PC
( pdf, 3.82 MB )
(930 downloads)
Popular
21 Jul 2025
pdf
SUBMISSION OF MEDICAL DEVICE RE REGISTRATION APPLICATIONS VIA MeDC@St 2 0+ SYSTEM 05062025 (2)
( pdf, 174 KB )
(2976 downloads)
Popular
05 Jun 2025
pdf
Surat pekeliling bil 1 2021 (bi) Kelulusan Bersyarat Kit Ujian Kendiri
( pdf, 96 KB )
(3685 downloads)
Popular
18 Oct 2021
pdf
Surat pekeliling bil 1 2021 (bm) Kelulusan Bersyarat Kit Ujian Kendiri
( pdf, 108 KB )
(3080 downloads)
Popular
18 Oct 2021
pdf
surat pekeliling bil.1_2020 (bm)_Iklan 200520.pdf
( pdf, 91 KB )
(3785 downloads)
Popular
17 Mar 2023
pdf
surat pekeliling bil.1_2020 (Eng)_Iklan 200520.pdf
( pdf, 84 KB )
(4142 downloads)
Popular
17 Mar 2023
pdf
Surat Pekeliling Bil.1_2023 (BM)_Kebenaran Penjualan HIVST.pdf
( pdf, 1.25 MB )
(784 downloads)
Popular
21 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
Circular Letter
Guidance Document
Guideline
Standard
General Directions
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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