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
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
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DRAFT GUIDANCE DOCUMENTS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
Pelan Anti Rasuah
Buletin MDA
Contoh Kategori Docman
Press Release
MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
Pekeliling Kerajaan
Customer Satisfaction Survey Report
Integrity Information
Training Academy (COE)
Search
Reset
Toggle
Title
Date
pdf
GD 0058 PERSONAL PROTECTIVE EQUIPMENT (PPE) REQUIREMENTS
( pdf, 381 KB )
(15333 downloads)
Popular
27 May 2022
pdf
GD CI
( pdf, 1.33 MB )
(3244 downloads)
Popular
01 Mar 2018
pdf
GD Code of Advertisement COA 8 April 2021 v2
( pdf, 352 KB )
(17768 downloads)
Popular
08 Apr 2021
pdf
GD Code of Advertisement COA 8 April 2021 v2
( pdf, 354 KB )
(3914 downloads)
Popular
29 Nov 2021
pdf
GD Code of Advertisement COA 8 April 2021 v2
( pdf, 375 KB )
(8188 downloads)
Popular
29 Mar 2022
pdf
GD IVD Product Grouping MDAGD0054
( pdf, 977 KB )
(17010 downloads)
Popular
20 May 2022
pdf
GD Notification of Export Only 60 0016 Julai 2019
( pdf, 458 KB )
(9574 downloads)
Popular
16 Jul 2019
pdf
GD Notification of Export Only 60 0016 Julai 2019
( pdf, 460 KB )
(13862 downloads)
Popular
29 Nov 2021
pdf
GD of Product Classification 4th Ver 2025
( pdf, 374 KB )
(584 downloads)
Popular
25 Oct 2025
pdf
GD PPE Requirements
( pdf, 374 KB )
(6426 downloads)
Popular
02 Sep 2021
pdf
GD PPE Requirements
( pdf, 376 KB )
(10612 downloads)
Popular
29 Nov 2021
pdf
GD REGISTRATION AND NOTIFICATION OF LISTING FOR REFURBISHED MEDICAL DEVICE 281021 (GDAC) (2)
( pdf, 190 KB )
(16131 downloads)
Popular
18 Feb 2022
pdf
GD0055 NOTIFICATION FOR OBSOLETE DISCONTINUED MD 16APR2020
( pdf, 1.44 MB )
(12054 downloads)
Popular
20 Apr 2020
pdf
GD0055 NOTIFICATION FOR OBSOLETE DISCONTINUED MD 16APR2020
( pdf, 1.44 MB )
(6971 downloads)
Popular
29 Nov 2021
pdf
GD0056 SA Ventilator 60 60 27April2020
( pdf, 584 KB )
(11676 downloads)
Popular
27 Apr 2020
pdf
GD0056 SA Ventilator 60 60 27April2020
( pdf, 586 KB )
(10892 downloads)
Popular
29 Nov 2021
pdf
GD0057 Medical Gas System Requirements for Registration 30 99 First Edit
( pdf, 853 KB )
(9665 downloads)
Popular
03 Jun 2020
pdf
GD0057 Medical Gas System Requirements for Registration 30 99 First Edit
( pdf, 855 KB )
(8251 downloads)
Popular
29 Nov 2021
pdf
GDPMD MDARR
( pdf, 410 KB )
(36154 downloads)
Popular
14 Apr 2018
pdf
GDPMD MDARR
( pdf, 411 KB )
(68783 downloads)
Popular
29 Nov 2021
«
1
2
3
4
5
6
7
…
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
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
×
