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DRAFT GUIDANCE DOCUMENTS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
pdf
(MDA FCA P1424 54608372 2025)
( pdf, 280 KB )
(1587 downloads)
Popular
03 Nov 2025
pdf
(MDA FCA P1485 66161130 2025)
( pdf, 247 KB )
(1014 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1486 42193501 2025)
( pdf, 247 KB )
(962 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1491 18920993 2025)
( pdf, 91 KB )
(1004 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1504 99314995 2025)
( pdf, 304 KB )
(1043 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1507 18659597 2025)
( pdf, 252 KB )
(983 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1510 65368455 2025)
( pdf, 358 KB )
(986 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1511 45392626 2025)
( pdf, 177 KB )
(1017 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1512 82035188 2025)
( pdf, 218 KB )
(962 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1514 30083507 2025)
( pdf, 642 KB )
(957 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1515 87710769 2025)
( pdf, 642 KB )
(989 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1516 89822650 2025)
( pdf, 642 KB )
(1010 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1518 42904626 2025)
( pdf, 2.64 MB )
(893 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1519 89119626 2025)
( pdf, 782 KB )
(941 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1520 84395290 2025)
( pdf, 404 KB )
(1003 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1521 67496360 2025)
( pdf, 404 KB )
(1059 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1523 17673542 2025)
( pdf, 297 KB )
(1032 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1524 48647908 2025)
( pdf, 91 KB )
(1007 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1525 50078774 2025)
( pdf, 297 KB )
(965 downloads)
Popular
06 Jan 2026
pdf
(MDA FCA P1526 76000419 2025)
( pdf, 91 KB )
(973 downloads)
Popular
06 Jan 2026
1
2
3
…
44
45
»
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
×
