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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DRAFT GUIDANCE DOCUMENTS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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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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pdf
Guidance Document Harmonised Classification of Medical Device in ASEAN Second Edition.pdf
( pdf, 471 KB )
(489 downloads)
Popular
12 Dec 2023
pdf
Guidance Document HIV Self-test kit First Edition.pdf
( pdf, 630 KB )
(670 downloads)
Popular
19 Feb 2024
pdf
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM.pdf
( pdf, 274 KB )
(1033 downloads)
Popular
02 Sep 2024
pdf
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM.pdf
( pdf, 126 KB )
(1341 downloads)
Popular
12 Mar 2024
pdf
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM.pdf
( pdf, 126 KB )
(313 downloads)
Popular
22 Apr 2024
pdf
HEARTSTART INTREPID.pdf
( pdf, 412 KB )
(1279 downloads)
Popular
02 Sep 2024
pdf
HEMOSIL LIQUID ANTI-XA.pdf
( pdf, 765 KB )
(960 downloads)
Popular
14 Jan 2025
pdf
HEMOSTASIS DEVICES.pdf
( pdf, 320 KB )
(1157 downloads)
Popular
17 Dec 2024
pdf
HISCL HBSAG ASSAY KIT.pdf
( pdf, 2.04 MB )
(447 downloads)
Popular
12 Mar 2024
pdf
HISCL HBSAG ASSAY KIT.pdf
( pdf, 2.04 MB )
(1194 downloads)
Popular
22 Apr 2024
pdf
HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 Third edition
( pdf, 1.12 MB )
(9523 downloads)
Popular
18 Oct 2022
pdf
ICHEM VELOCITY URINE CHEMISTRY SYSTEM.pdf
( pdf, 1.13 MB )
(946 downloads)
Popular
17 Dec 2024
document
IDS-24-5142 Distributor Letter_SEA (MDA_Recall_P0347_99297066_2024) (gRSr1EQ9) (1).docx
( docx, 69 KB )
(932 downloads)
Popular
17 Dec 2024
document
IDS-25-5245 Customer Letter_SEA (Recall) (MDA_Recall_P0368_61499460_2025) (XvqkrqAl) (1).docx
( docx, 66 KB )
(793 downloads)
Popular
03 Mar 2025
pdf
IDYLLA™ SYSTEM - IDYLLA™ CONSOLE AND IDYLLA™ INSTRUMENT, IDYLLA™ MSI TEST.pdf
( pdf, 333 KB )
(844 downloads)
Popular
14 Jan 2025
pdf
IKLAN JAWATAN PEGAWAI UNDANG-UNDANG GRED L41 (Contract For Service)
( pdf, 802 KB )
(289 downloads)
Popular
16 Jul 2024
pdf
Iklan Jawatan Penolong Pegawai Tadbir Gred N29 - ROBIATUN ADAWIYAH BINTI ZAINON (MDA).pdf
( pdf, 855 KB )
(1648 downloads)
Popular
12 Sep 2024
pdf
Iklan Penolong Pegawai Teknologi Maklumat FA5 - Contract For Service (CFS).pdf
( pdf, 2.93 MB )
(1679 downloads)
Popular
26 Feb 2025
pdf
IKLAN SEBUT HARGA MEMBEKAL DAN MENGHANTAR BARANGAN.pdf
( pdf, 57 KB )
(557 downloads)
Popular
26 Feb 2025
pdf
IMMULITE IMMULITE 1000 TNF ALPHA.pdf
( pdf, 222 KB )
(962 downloads)
Popular
17 Dec 2024
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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
Corporate Communication Unit
Legal Unit
Integrity Unit
Secretarial Unit
Pre-Market Control Division
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Management and Service 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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