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DRAFT GUIDANCE DOCUMENTS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
A2008 010
( pdf, 174 KB )
(4196 downloads)
Popular
03 Sep 2019
pdf
A2008 011
( pdf, 306 KB )
(3778 downloads)
Popular
03 Sep 2019
pdf
A2008 012
( pdf, 1.05 MB )
(3466 downloads)
Popular
03 Sep 2019
pdf
A2008 013
( pdf, 995 KB )
(3601 downloads)
Popular
03 Sep 2019
pdf
Affected Medical Device
( pdf, 97 KB )
(3869 downloads)
Popular
08 Aug 2022
pdf
AIMC 25-06 UFSN 2025-04-15 (Country Letterhead) (MDA_FCA_P1271_41660423_2025) (regURuDP).pdf
( pdf, 367 KB )
(2036 downloads)
Popular
05 May 2025
pdf
AIMC 25-06 UFSN 2025-04-15 (Country Letterhead) (MDA_FCA_P1272_71088702_2025) (s7psq1I3).pdf
( pdf, 367 KB )
(1933 downloads)
Popular
05 May 2025
pdf
Alert 200901 01
( pdf, 94 KB )
(3284 downloads)
Popular
03 Sep 2019
pdf
Alert 200901 02
( pdf, 327 KB )
(3222 downloads)
Popular
03 Sep 2019
pdf
Alert 200901 03
( pdf, 89 KB )
(3730 downloads)
Popular
03 Sep 2019
pdf
Attachment 01-FMI34139 - FSN Customer Letter (MDA_FCA_P1139_89761501_2025) (eQQVAwwZ).pdf
( pdf, 787 KB )
(1986 downloads)
Popular
05 Feb 2025
Image
Baxter 20081201 01
( jpg, 227 KB )
(3245 downloads)
Popular
03 Sep 2019
Image
Baxter 20081201 02
( jpg, 225 KB )
(3329 downloads)
Popular
03 Sep 2019
Image
Baxter 20081201 03
( jpg, 54 KB )
(3355 downloads)
Popular
03 Sep 2019
Image
Baxter 20081201 04
( jpg, 118 KB )
(3096 downloads)
Popular
03 Sep 2019
pdf
BaxterUrgentNotice01Mac2010
( pdf, 895 KB )
(4060 downloads)
Popular
04 Sep 2019
pdf
BaxterUrgentNotice02Mac2010
( pdf, 421 KB )
(7799 downloads)
Popular
04 Sep 2019
pdf
CL2024-312dm (MDA_FCA_P1155_80197836_2025) (JCNHmGVg).pdf
( pdf, 331 KB )
(2090 downloads)
Popular
05 Feb 2025
pdf
CL2025 111dm (MDA FCA P1325 38709250 2025) (27BqIyrq)
( pdf, 202 KB )
(2056 downloads)
Popular
26 Jun 2025
pdf
CL2025 113dm (MDA FCA P1315 72182972 2025) (VrWxGx46)
( pdf, 150 KB )
(2081 downloads)
Popular
26 Jun 2025
«
1
2
…
23
24
25
26
27
…
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
×
