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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DRAFT GUIDANCE DOCUMENTS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
Classification Guide on Human Cell Tissue Based Products (4)
( pdf, 239 KB )
(1928 downloads)
Popular
21 Jul 2025
pdf
Classification of Rehabilitation, Physiotherapy and Speech Therapy Devices Second Edition.pdf
( pdf, 420 KB )
(719 downloads)
Popular
28 Aug 2023
pdf
Clinical Investigational Plan (CIP) x 2 - NUR MAIZURA BINTI ZARMANI (MDA).pdf
( pdf, 197 KB )
(864 downloads)
Popular
05 Apr 2023
pdf
Clinical Investigational Plan (CIP).pdf
( pdf, 197 KB )
(6074 downloads)
Popular
05 Apr 2023
pdf
CO BI PDF
( pdf, 208 KB )
(1087 downloads)
Popular
27 Oct 2025
pdf
Compilation of Questions & Answers Related to IVD Issues.pdf
( pdf, 186 KB )
(616 downloads)
Popular
08 Aug 2024
pdf
Compilation of Questions & Answers Related to IVD Issues.pdf
( pdf, 186 KB )
(2865 downloads)
Popular
08 Aug 2024
document
Consultancy Request Form (Non-Package) (3).docx
( docx, 104 KB )
(5767 downloads)
Popular
21 Aug 2023
document
Consultancy Request Form (Non-Package) - LUQMAN HAFIFI BIN CHE YUSSOF (MDA).docx
( docx, 104 KB )
(573 downloads)
Popular
21 Aug 2023
document
Consultancy Request Form (Non-Package).docx
( docx, 104 KB )
(1013 downloads)
Popular
02 Aug 2023
document
Consultancy Request Form (Package) (3).docx
( docx, 470 KB )
(6088 downloads)
Popular
21 Aug 2023
document
Consultancy Request Form (Package) - LUQMAN HAFIFI BIN CHE YUSSOF (MDA).docx
( docx, 470 KB )
(545 downloads)
Popular
21 Aug 2023
document
Consultancy Request Form (Package).docx
( docx, 470 KB )
(1096 downloads)
Popular
02 Aug 2023
pdf
Create Medcast Account
( pdf, 315 KB )
(1267 downloads)
Popular
24 Nov 2025
pdf
D SPECIAL ACCESS MEDICAL DEVICE THIRD EDITION
( pdf, 473 KB )
(339 downloads)
New
Popular
30 Mar 2026
pdf
Data manufacturer - Copy of Sheet1.pdf
( pdf, 1.24 MB )
(3936 downloads)
Popular
14 Mar 2025
pdf
DECISION FROM MESYUARAT JAWATANKUASA TEKNIKAL PENDAFTARAN UMUM REQUIREMENTS ON QMS AND TRACEABILITY FORM (2).pdf
( pdf, 13 KB )
(4035 downloads)
Popular
07 Aug 2023
pdf
DECISION FROM MESYUARAT JAWATANKUASA TEKNIKAL PENDAFTARAN UMUM REQUIREMENTS ON QMS AND TRACEABILITY FORM.pdf
( pdf, 13 KB )
(1124 downloads)
Popular
25 Jul 2023
pdf
DECISION JAWATANKUASA TEKNIKAL PENGKELASAN DAN PENDAFTARAN 2025
( pdf, 157 KB )
(285 downloads)
Popular
06 Feb 2026
pdf
Dispute Class Risk Form v1
( pdf, 62 KB )
(620 downloads)
Popular
26 May 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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