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
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
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DRAFT GUIDANCE DOCUMENTS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
pdf
GSK 02 10
( pdf, 844 KB )
(3681 downloads)
Popular
04 Sep 2019
pdf
HC 25 01 UFSN 2025 06 04 ADVIA 2120 SETpoint TESTpoint Controls (Country Letterhead) (MDA FCA P1319 85603243 2025) (Z3tKzpsV)
( pdf, 250 KB )
(1111 downloads)
Popular
26 Jun 2025
pdf
ISIFA2024-10-C Pitch Cable Failure Customer Letter (5556046-01) MY (MDA_FCA_P1119_22749179_2024) (K2vhlJz0).pdf
( pdf, 731 KB )
(1392 downloads)
Popular
05 Feb 2025
pdf
Jun2010Lifepak20n20E
( pdf, 543 KB )
(3652 downloads)
Popular
04 Sep 2019
pdf
March2010FCA LifePak 15
( pdf, 400 KB )
(2997 downloads)
Popular
04 Sep 2019
pdf
May09 JnJLetter CypherSelect
( pdf, 248 KB )
(3001 downloads)
Popular
04 Sep 2019
pdf
May09 JnJRegulator letter
( pdf, 222 KB )
(3008 downloads)
Popular
04 Sep 2019
pdf
May19 FCA Kappa Sigma
( pdf, 1.27 MB )
(3122 downloads)
Popular
04 Sep 2019
pdf
MDA FCA P1329 50752364 2025
( pdf, 152 KB )
(955 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1334 87016889 2025
( pdf, 226 KB )
(955 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1335 89426102 2025
( pdf, 288 KB )
(956 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1337 62169875 2025
( pdf, 222 KB )
(978 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1338 29785669 2025
( pdf, 367 KB )
(951 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1340 27664088 2025
( pdf, 367 KB )
(929 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1343 64731909 2025
( pdf, 668 KB )
(986 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1345 81037322 2025
( pdf, 362 KB )
(1004 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1346 57143498 2025
( pdf, 435 KB )
(912 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1347 86178611 2025
( pdf, 435 KB )
(855 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1348 95281166 2025
( pdf, 435 KB )
(874 downloads)
Popular
07 Aug 2025
pdf
MDA FCA P1349 99925107 2025
( pdf, 435 KB )
(873 downloads)
Popular
07 Aug 2025
«
1
2
…
30
31
32
33
34
…
41
42
»
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
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
Training Academy (COE)
Speakers
Registration
Licensing
Comformity Assessment Body (CAB)
Syllabus
Registration
Licensing
Comformity Assessment Body (CAB)
Training Schedule
×
