Our Hotline
+603 - 8230 0300
Home
Introduction
Background
Vision, Mission & Core Value
Functions
Contact Us
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
Customer Satisfaction Survey
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)
Customer Satisfaction Survey Result
Annual Report
Search
fas fa-search
Home
Documents
FCA
Loading...
Folder
FCA
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DRAFT GUIDANCE DOCUMENTS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
Search
Reset
Toggle
Title
Date
document
20100308 05 A Mdtrnc
( doc, 320 KB )
(2340 downloads)
Popular
04 Sep 2019
document
20100427 InfusionPump
( doc, 332 KB )
(2397 downloads)
Popular
04 Sep 2019
document
20100503 06 AN Tomotherapy
( doc, 320 KB )
(2323 downloads)
Popular
04 Sep 2019
document
20100510 07 A Mdtrnc
( doc, 320 KB )
(2312 downloads)
Popular
04 Sep 2019
document
20100609 07 A Mdtrnc Lifepak
( doc, 321 KB )
(2337 downloads)
Popular
04 Sep 2019
document
20100712 10 Alert VarianLINAC
( doc, 320 KB )
(2424 downloads)
Popular
05 Sep 2019
pdf
20100712 MDB Malaysia
( pdf, 257 KB )
(2254 downloads)
Popular
05 Sep 2019
pdf
20100712 RJ RRBC Information
( pdf, 221 KB )
(2540 downloads)
Popular
05 Sep 2019
document
20100719 11 CSL IVD
( doc, 324 KB )
(2311 downloads)
Popular
05 Sep 2019
document
20100818 12 FSN Tomotherapy
( doc, 321 KB )
(2438 downloads)
Popular
05 Sep 2019
document
20100907 13 FSN Thoratec
( doc, 320 KB )
(2431 downloads)
Popular
05 Sep 2019
document
20101015 14 A Mdtrnc 5388
( doc, 321 KB )
(2423 downloads)
Popular
05 Sep 2019
document
20101112 16 AdvisoryNotice T Medic
( doc, 320 KB )
(2379 downloads)
Popular
05 Sep 2019
pdf
20101112 16 T Medic
( pdf, 81 KB )
(2203 downloads)
Popular
05 Sep 2019
document
2011 04 15 03A Mdtronic
( doc, 324 KB )
(2678 downloads)
Popular
05 Sep 2019
pdf
2011 04 15 2
( pdf, 1.15 MB )
(2727 downloads)
Popular
05 Sep 2019
document
2011 06 23 05A JnJ cypherselectstent
( doc, 323 KB )
(2369 downloads)
Popular
05 Sep 2019
pdf
2011 06 23 05A JnJ cypherselectstent2
( pdf, 129 KB )
(2322 downloads)
Popular
05 Sep 2019
document
2011 07 18 06A Fisher n Paykel CPAP Humid
( doc, 324 KB )
(2583 downloads)
Popular
05 Sep 2019
pdf
2021 06 A CPAP FSN Letter
( pdf, 159 KB )
(3475 downloads)
Popular
16 Jul 2021
«
1
2
…
5
6
7
8
9
…
32
33
»
Home
Introduction
Background
Vision, Mission & Core Value
Functions
Contact Us
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
Customer Satisfaction Survey
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)
Customer Satisfaction Survey Result
Annual Report
×