Our Hotline
+603 - 8230 0300
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
Search
fas fa-search
Home
Documents
GUIDANCE DOCUMENTS
Loading...
Folder
GUIDANCE DOCUMENTS
Documents
Search for documents
Find by title or description…
Category
recall
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DRAFT GUIDANCE DOCUMENTS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
powerpoint_presentation
Forms
Events
Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
Product Classification
MDA Staff - Forms
Training Programme
FCA
UKK
Strategic Plan
INFOGRAPHIC
- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
Buletin MDA
Contoh Kategori Docman
Press Release
MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
Pekeliling Kerajaan
Customer Satisfaction Survey Report
Search
Reset
Toggle
Title
Date
pdf
MDAGD0043 SpecialAccess 15May2020 60 00
( pdf, 627 KB )
(16103 downloads)
Popular
29 Nov 2021
pdf
MDAGD0045 CFS for EO MD Nov2018
( pdf, 477 KB )
(7492 downloads)
Popular
29 Nov 2021
pdf
MDA_GD0009_Classification of General Medical Device 2nd Edition_edited Rule1.pdf
( pdf, 1.01 MB )
(12383 downloads)
Popular
21 Nov 2022
pdf
Medical Device - Drugs - Cosmetic Interphase (MDDCI) and Combination Products (Table MDDCI 2025)
( pdf, 425 KB )
(51 downloads)
New
13 Aug 2025
pdf
MEDICAL DEVICE GUIDANCE DOCUMENT
( pdf, 176 KB )
(6460 downloads)
Popular
06 Mar 2018
pdf
Medical Device Recall
( pdf, 686 KB )
(4848 downloads)
Popular
19 Nov 2021
pdf
Medical Device Recall 60 90 2July2020 edited GDAC decision
( pdf, 431 KB )
(12234 downloads)
Popular
02 Jul 2020
pdf
Medical Device Recall 60 90 2July2020 edited GDAC decision
( pdf, 431 KB )
(20037 downloads)
Popular
29 Nov 2021
pdf
Medical Face Mask and Respirator
( pdf, 317 KB )
(6143 downloads)
Popular
19 Nov 2021
pdf
Medical Face Mask and Respirator Third Edition.pdf
( pdf, 317 KB )
(7547 downloads)
Popular
19 May 2023
pdf
Medical face mask Guidelines GDAC Bil 7 2021
( pdf, 312 KB )
(3410 downloads)
Popular
29 Oct 2021
pdf
Medical face mask Guidelines GDAC Bil 7 2021
( pdf, 314 KB )
(7539 downloads)
Popular
29 Nov 2021
pdf
Medical Gas System – Requirements for Registration
( pdf, 547 KB )
(1768 downloads)
Popular
19 Nov 2021
pdf
Medical Gas Systems-Requirements for Registration.pdf
( pdf, 524 KB )
(9981 downloads)
Popular
13 Feb 2023
pdf
Notification Demonstration
( pdf, 771 KB )
(4959 downloads)
Popular
01 Nov 2017
pdf
Notification For Obsolete And Discontinued Medical Device
( pdf, 649 KB )
(2971 downloads)
Popular
19 Nov 2021
pdf
Notification of Custom-made Medical Device - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).pdf
( pdf, 460 KB )
(1060 downloads)
Popular
01 Mar 2023
pdf
Notification of Custom-made Medical Device.pdf
( pdf, 460 KB )
(7166 downloads)
Popular
01 Mar 2023
pdf
Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation
( pdf, 683 KB )
(2576 downloads)
Popular
19 Nov 2021
pdf
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
( pdf, 335 KB )
(2685 downloads)
Popular
16 Nov 2021
«
1
2
…
7
8
9
10
»
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
×
