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
Integrity Information
Search
fas fa-search
Home
Documents
recall
Loading...
Folder
recall
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DRAFT GUIDANCE DOCUMENTS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
Search
Reset
Toggle
Title
Date
pdf
2011 05 19 11R CoreValve2
( pdf, 377 KB )
(3584 downloads)
Popular
03 Sep 2019
document
2012 01 26 01R RESPIRONICS usfda
( doc, 323 KB )
(3898 downloads)
Popular
03 Sep 2019
Image
2024-MDA-RIS Poster - NUR RASIDAH BT NGASBON (MDA).png
( png, 640 KB )
(314 downloads)
Popular
07 Jan 2025
pdf
2a. Global_FSN Letter_FSCA287_2025-01-21 (MDA_FCA_P1197_84272830_2025) (2eBWyvBb).pdf
( pdf, 5.07 MB )
(761 downloads)
Popular
03 Mar 2025
pdf
3- APPENDIX-2---Medical-Device-Drug-Cosmetic-Interphase-MDDCI-and-Combination-Products.pdf
( pdf, 778 KB )
(2842 downloads)
Popular
28 Feb 2024
pdf
4. Process Flow for Endorsement Letter for Ancillary Medical Device Component Application.pdf
( pdf, 35 KB )
(1251 downloads)
Popular
28 Feb 2024
document
5. Appendix 3 - Application form for endorsement letter of ancillary component for the registration of combination product – Appendix 3 (2).doc
( doc, 233 KB )
(2043 downloads)
Popular
28 Feb 2024
pdf
6 DEF OF MD
( pdf, 442 KB )
(9400 downloads)
Popular
10 May 2019
pdf
6. Overview of Post Approval Changes of a Registered Combination Product (Changes to Ancillary Medical Device Component) Framework.pdf
( pdf, 160 KB )
(1777 downloads)
Popular
28 Feb 2024
pdf
7. Process Flow for Approval Letter for Changes to Ancillary Medical Device Component Application.pdf
( pdf, 35 KB )
(802 downloads)
Popular
28 Feb 2024
document
8a. Appendix 4 - Application form for change variation of ancillary components for combination products – Appendix 4 (2).doc
( doc, 201 KB )
(1450 downloads)
Popular
28 Feb 2024
document
8b. Summary table of changes (1).doc
( doc, 92 KB )
(1587 downloads)
Popular
28 Feb 2024
pdf
9. Information on Fee Structure for Application of Endorsement Letter and Approval Letter for Post-Approval Changes, of Ancillary Medical Device Component.pdf
( pdf, 38 KB )
(1759 downloads)
Popular
28 Feb 2024
pdf
Abbott FSN - Assurity Endurity 2025 - Malaysia v2 (MDA_FCA_P1198_55805208_2025) (YUj5lbco).pdf
( pdf, 312 KB )
(929 downloads)
Popular
03 Mar 2025
pdf
ACCESS AFP (300 TEST KIT).pdf
( pdf, 518 KB )
(415 downloads)
Popular
12 Mar 2024
pdf
ACCESS AFP (300 TEST KIT).pdf
( pdf, 518 KB )
(1692 downloads)
Popular
22 Apr 2024
pdf
ACCESS BONE METABOLISM ASSAYS.pdf
( pdf, 561 KB )
(901 downloads)
Popular
17 Dec 2024
pdf
ACCESS CORTISOL.pdf
( pdf, 393 KB )
(864 downloads)
Popular
17 Dec 2024
pdf
ACCESS HBC AB.pdf
( pdf, 471 KB )
(1004 downloads)
Popular
02 Sep 2024
pdf
ACCESS HSTNI.pdf
( pdf, 422 KB )
(1049 downloads)
Popular
17 Dec 2024
«
1
2
…
4
5
6
7
8
…
31
32
»
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
Integrity Information
×
