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DRAFT GUIDANCE DOCUMENTS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
1 IVD MEDICAL DEVICE CLASSIFICATION SYSTEM
( pdf, 556 KB )
(20832 downloads)
Popular
14 Apr 2018
pdf
16 Notification for Clinical Research or Performance evaluation
( pdf, 1.58 MB )
(13208 downloads)
Popular
14 Apr 2018
pdf
16 Notification for Clinical Research or Performance evaluation
( pdf, 1.58 MB )
(18503 downloads)
Popular
29 Nov 2021
pdf
18 Notification Demonstration
( pdf, 913 KB )
(7590 downloads)
Popular
14 Apr 2018
pdf
190220 GDAC 3 Requirement CAB To Publish
( pdf, 1.34 MB )
(15683 downloads)
Popular
07 Sep 2020
pdf
190220 GDAC 3 Requirement CAB To Publish
( pdf, 1.34 MB )
(17831 downloads)
Popular
30 Nov 2021
pdf
2 EPSP OF IVD MEDICAL DEVICES
( pdf, 497 KB )
(20817 downloads)
Popular
14 Apr 2018
pdf
2 EPSP OF IVD MEDICAL DEVICES
( pdf, 499 KB )
(11442 downloads)
Popular
29 Nov 2021
pdf
20 Change Notification Scope
( pdf, 871 KB )
(5810 downloads)
Popular
14 Apr 2018
pdf
20191121 GD Notification Demonstration
( pdf, 380 KB )
(19693 downloads)
Popular
07 Jan 2020
pdf
20191121 GD Notification Demonstration
( pdf, 383 KB )
(3053 downloads)
Popular
29 Nov 2021
pdf
202012 GD IVD Product Grouping MDAGD0054
( pdf, 1.16 MB )
(3235 downloads)
Popular
28 Mar 2022
pdf
202012 GD IVD Product Grouping MDAGD0054 (1)
( pdf, 1.81 MB )
(11235 downloads)
Popular
15 Apr 2021
pdf
202012 GD IVD Product Grouping MDAGD0054 (1)
( pdf, 1.82 MB )
(4296 downloads)
Popular
30 Nov 2021
pdf
24 Requirement for Export Permit
( pdf, 648 KB )
(7738 downloads)
Popular
14 Apr 2018
pdf
24 Requirement for Export Permit
( pdf, 651 KB )
(15567 downloads)
Popular
29 Nov 2021
pdf
25 Declaration of Conformity
( pdf, 478 KB )
(31484 downloads)
Popular
14 Apr 2018
pdf
25 Declaration of Conformity
( pdf, 480 KB )
(36075 downloads)
Popular
29 Nov 2021
pdf
26 Requirement on Labelling of MD
( pdf, 608 KB )
(6870 downloads)
Popular
14 Apr 2018
pdf
27 Licensing for establishment
( pdf, 746 KB )
(45239 downloads)
Popular
14 Apr 2018
1
2
3
…
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
×
