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DRAFT GUIDANCE DOCUMENTS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
MDA GD 0060 REFURBISHED MEDICAL DEVICE REQUIREMENTS (2)
( pdf, 190 KB )
(1879 downloads)
Popular
08 Feb 2022
pdf
MDA GD0009 Classification of General Medical Device
( pdf, 963 KB )
(25608 downloads)
Popular
09 May 2022
pdf
MDA GD0009 Classification of General Medical Device (1)
( pdf, 961 KB )
(8755 downloads)
Popular
20 May 2022
pdf
MDA GD0026 Requirement on Labelling of MD Post GDAC 28 Oct 2021 v7 Final
( pdf, 343 KB )
(3150 downloads)
Popular
29 Oct 2021
pdf
MDA GD0026 Requirement on Labelling of MD Post GDAC 28 Oct 2021 v7 Final
( pdf, 346 KB )
(10745 downloads)
Popular
29 Nov 2021
pdf
MDA GD0026 REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES
( pdf, 308 KB )
(10006 downloads)
Popular
22 Jun 2022
pdf
MDA GD0059 Requirement on COVID 19 Test KIt Selling Portal
( pdf, 260 KB )
(5490 downloads)
Popular
29 Mar 2022
pdf
MDA GD0059 Requirement on COVID 19 Test KIt Selling SY EDITED NOV2021 v3
( pdf, 282 KB )
(5650 downloads)
Popular
09 Nov 2021
pdf
MDA GD0059 Requirement on COVID 19 Test KIt Selling SY EDITED NOV2021 v3
( pdf, 284 KB )
(10355 downloads)
Popular
29 Nov 2021
pdf
MDA/GD-01 March 2014 First Edition - DEFINITION OF MEDICAL DEVICE
( pdf, 304 KB )
(18158 downloads)
Popular
24 Mar 2014
pdf
MDA/GD-02 March 2014 First Edition - ESSENTIAL PRINCIPLES OF SAFETY & PERFORMANCE OF MEDICAL DEVICE
( pdf, 311 KB )
(16935 downloads)
Popular
24 Mar 2014
pdf
MDA/GD-03 March 2014 First Edition - COMMON SUBMISSION DOSSIER TEMPLATE
( pdf, 442 KB )
(26594 downloads)
Popular
24 Mar 2014
pdf
MDA/GD-04 March 2014 First Edition - THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES
( pdf, 1.86 MB )
(50283 downloads)
Popular
24 Mar 2014
pdf
MDA/GD-05 October 2013 First Edition- GUIDANCE ON THE PRODUCT GROUPING
( pdf, 739 KB )
(31693 downloads)
Popular
13 Dec 2013
pdf
MDAGD0001 IVD risk classification MD 2nd 60 60
( pdf, 361 KB )
(8290 downloads)
Popular
26 Jan 2021
pdf
MDAGD0001 IVD risk classification MD 2nd 60 60
( pdf, 363 KB )
(25521 downloads)
Popular
29 Nov 2021
pdf
MDAGD0020 Change Notification 3rd Ed November 2018
( pdf, 516 KB )
(13889 downloads)
Popular
29 Nov 2021
pdf
MDAGD0033 Medical face mask Guidelines 60 60 18JAN2021 (2)
( pdf, 328 KB )
(18358 downloads)
Popular
19 Jan 2021
pdf
MDAGD0043 SpecialAccess 15May2020 60 00
( pdf, 623 KB )
(14782 downloads)
Popular
18 May 2020
pdf
MDAGD0043 SpecialAccess 15May2020 60 00
( pdf, 627 KB )
(15571 downloads)
Popular
29 Nov 2021
«
1
2
…
6
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
×
