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DRAFT GUIDANCE DOCUMENTS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
pdf
Alert 200901 02
( pdf, 327 KB )
(2413 downloads)
Popular
03 Sep 2019
pdf
Alert 200901 03
( pdf, 89 KB )
(2627 downloads)
Popular
03 Sep 2019
pdf
Attachment 01-FMI34139 - FSN Customer Letter (MDA_FCA_P1139_89761501_2025) (eQQVAwwZ).pdf
( pdf, 787 KB )
(350 downloads)
Popular
05 Feb 2025
Image
Baxter 20081201 01
( jpg, 227 KB )
(2265 downloads)
Popular
03 Sep 2019
Image
Baxter 20081201 02
( jpg, 225 KB )
(2309 downloads)
Popular
03 Sep 2019
Image
Baxter 20081201 03
( jpg, 54 KB )
(2321 downloads)
Popular
03 Sep 2019
Image
Baxter 20081201 04
( jpg, 118 KB )
(2155 downloads)
Popular
03 Sep 2019
pdf
BaxterUrgentNotice01Mac2010
( pdf, 895 KB )
(3010 downloads)
Popular
04 Sep 2019
pdf
BaxterUrgentNotice02Mac2010
( pdf, 421 KB )
(5710 downloads)
Popular
04 Sep 2019
pdf
CL2024-312dm (MDA_FCA_P1155_80197836_2025) (JCNHmGVg).pdf
( pdf, 331 KB )
(386 downloads)
Popular
05 Feb 2025
pdf
Customer Acknowledgement Letter (MDA_FCA_P1286_27738822_2025) (20ClHApu).pdf
( pdf )
(75 downloads)
05 May 2025
pdf
D001514358_2022-IGT-BST-007_FSN_signed (MDA_FCA_P1140_89562790_2025) (3zRBVkTM).pdf
( pdf, 589 KB )
(81 downloads)
05 Feb 2025
pdf
D001514358_2022-IGT-BST-007_FSN_signed (MDA_FCA_P1141_96278555_2025) (gHKqYFn1).pdf
( pdf, 589 KB )
(79 downloads)
05 Feb 2025
pdf
D001514358_2022-IGT-BST-007_FSN_signed (MDA_FCA_P1142_86242538_2025) (JIshdaEi).pdf
( pdf, 589 KB )
(104 downloads)
Popular
05 Feb 2025
pdf
D001514358_2022-IGT-BST-007_FSN_signed (MDA_FCA_P1143_51459141_2025) (a3Yc0Q2E).pdf
( pdf, 589 KB )
(386 downloads)
Popular
05 Feb 2025
pdf
D001730696_2023-IGT-BST-015_FSN_signed (MDA_FCA_P1144_22082165_2025) (ISemBT4v).pdf
( pdf, 499 KB )
(109 downloads)
Popular
05 Feb 2025
pdf
D001730696_2023-IGT-BST-015_FSN_signed (MDA_FCA_P1145_93022840_2025) (AwdAKhnU).pdf
( pdf, 499 KB )
(75 downloads)
05 Feb 2025
pdf
D001730696_2023-IGT-BST-015_FSN_signed (MDA_FCA_P1147_40137943_2025) (wbr29Lva).pdf
( pdf, 499 KB )
(113 downloads)
Popular
05 Feb 2025
pdf
D001730696_2023-IGT-BST-015_FSN_signed (MDA_FCA_P1148_34304365_2025) (wpI8iZr8).pdf
( pdf, 499 KB )
(336 downloads)
Popular
05 Feb 2025
document
DX-REG-160599-01-FSCA 5884 OUS Customer Letter (MDA_FCA_P1287_56624041_2025) (p4lbsSG4) (2).docx
( docx )
(65 downloads)
05 May 2025
«
1
2
…
21
22
23
24
25
…
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
×
