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
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DRAFT GUIDANCE DOCUMENTS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
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
document
20100427 InfusionPump
( doc, 332 KB )
(3676 downloads)
Popular
04 Sep 2019
document
20100503 06 AN Tomotherapy
( doc, 320 KB )
(3458 downloads)
Popular
04 Sep 2019
document
20100510 07 A Mdtrnc
( doc, 320 KB )
(3461 downloads)
Popular
04 Sep 2019
document
20100609 07 A Mdtrnc Lifepak
( doc, 321 KB )
(3423 downloads)
Popular
04 Sep 2019
document
20100712 10 Alert VarianLINAC
( doc, 320 KB )
(3519 downloads)
Popular
05 Sep 2019
pdf
20100712 MDB Malaysia
( pdf, 257 KB )
(3398 downloads)
Popular
05 Sep 2019
pdf
20100712 RJ RRBC Information
( pdf, 221 KB )
(3631 downloads)
Popular
05 Sep 2019
document
20100719 11 CSL IVD
( doc, 324 KB )
(3473 downloads)
Popular
05 Sep 2019
document
20100818 12 FSN Tomotherapy
( doc, 321 KB )
(3629 downloads)
Popular
05 Sep 2019
document
20100907 13 FSN Thoratec
( doc, 320 KB )
(3616 downloads)
Popular
05 Sep 2019
document
20101015 14 A Mdtrnc 5388
( doc, 321 KB )
(3560 downloads)
Popular
05 Sep 2019
document
20101112 16 AdvisoryNotice T Medic
( doc, 320 KB )
(3532 downloads)
Popular
05 Sep 2019
pdf
20101112 16 T Medic
( pdf, 81 KB )
(3408 downloads)
Popular
05 Sep 2019
document
2011 04 15 03A Mdtronic
( doc, 324 KB )
(3837 downloads)
Popular
05 Sep 2019
pdf
2011 04 15 2
( pdf, 1.15 MB )
(4093 downloads)
Popular
05 Sep 2019
document
2011 06 23 05A JnJ cypherselectstent
( doc, 323 KB )
(3532 downloads)
Popular
05 Sep 2019
pdf
2011 06 23 05A JnJ cypherselectstent2
( pdf, 129 KB )
(3599 downloads)
Popular
05 Sep 2019
document
2011 07 18 06A Fisher n Paykel CPAP Humid
( doc, 324 KB )
(3876 downloads)
Popular
05 Sep 2019
pdf
2021 06 A CPAP FSN Letter
( pdf, 159 KB )
(5880 downloads)
Popular
16 Jul 2021
pdf
2024 IGT BST 015 FSN D001915290 (MDA FCA P1318 19018758 2025) (hjOKpKck)
( pdf, 3.34 MB )
(2075 downloads)
Popular
26 Jun 2025
«
1
2
…
7
8
9
10
11
…
45
46
»
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
×
