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DRAFT GUIDANCE DOCUMENTS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
Product Grouping
( pdf, 648 KB )
(2622 downloads)
Popular
16 Nov 2021
pdf
Product Grouping for In Vitro Diagnostic (IVD) Medical Devices
( pdf, 1.11 MB )
(3381 downloads)
Popular
19 Nov 2021
pdf
Product Grouping for In Vitro Diagnostic (IVD) Medical Devices
( pdf, 1.11 MB )
(2322 downloads)
Popular
19 Nov 2021
pdf
Requirements For Application of Certificate of Free Sale (CFS) For Export Only Medical Devices
( pdf, 459 KB )
(6039 downloads)
Popular
19 Nov 2021
pdf
Requirements for Export Permit
( pdf, 349 KB )
(3070 downloads)
Popular
19 Nov 2021
pdf
Requirements for Export Permit
( pdf, 349 KB )
(1880 downloads)
Popular
19 Nov 2021
pdf
Requirements for Labelling of Medical Devices
( pdf, 313 KB )
(6857 downloads)
Popular
19 Nov 2021
pdf
Requirements For Labelling Of Medical Devices (revise)
( pdf, 440 KB )
(15805 downloads)
Popular
05 Feb 2018
pdf
Rules of Classification for General Medical Devices
( pdf, 2.15 MB )
(8874 downloads)
Popular
16 Nov 2021
pdf
Special Access – Requirements for Ventilator During Emergency Situation
( pdf, 1005 KB )
(1466 downloads)
Popular
19 Nov 2021
pdf
The Essential Principles of Safety and Performance of Medical Devices
( pdf, 255 KB )
(7164 downloads)
Popular
16 Nov 2021
document
WEBSITE ANNOUNCEMENT GD PPE
( docx, 16 KB )
(1515 downloads)
Popular
27 May 2022
pdf
[MDA/RR] MDARR No 1 First Revision November 15_6Nov15
( pdf, 410 KB )
(32100 downloads)
Popular
09 Nov 2015
«
1
2
…
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
×
