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DRAFT GUIDANCE DOCUMENTS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
1 C PBM 2025 01 Important Product Notice ROW (MDA FCA P1301 65308058 2025) (JcMNuIFj)
( pdf, 341 KB )
(2083 downloads)
Popular
26 Jun 2025
pdf
1-1.pdf
( pdf, 137 KB )
(4864 downloads)
Popular
14 Feb 2023
pdf
1-2025-01-01 FINAL Customer Notification - International Signed (MDA_FCA_P1262_78430519_2025) (x0k1BUz7).pdf
( pdf, 207 KB )
(1964 downloads)
Popular
05 May 2025
pdf
10
( pdf )
(55 downloads)
20 Oct 2022
pdf
10-1.pdf
( pdf, 223 KB )
(4381 downloads)
Popular
14 Feb 2023
pdf
10_11.pdf
( pdf, 471 KB )
(4646 downloads)
Popular
20 Dec 2022
pdf
10_12.pdf
( pdf, 493 KB )
(4279 downloads)
Popular
26 Jan 2023
pdf
10_3.pdf
( pdf, 174 KB )
(3510 downloads)
Popular
09 May 2023
pdf
10_5.pdf
( pdf, 334 KB )
(3349 downloads)
Popular
09 Aug 2023
pdf
10_56pdf
( pdf, 136 KB )
(3525 downloads)
Popular
27 Nov 2023
pdf
11
( pdf )
(68 downloads)
20 Oct 2022
pdf
11-1.pdf
( pdf, 277 KB )
(3713 downloads)
Popular
14 Feb 2023
pdf
11_1.pdf
( pdf, 1.06 MB )
(3094 downloads)
Popular
02 Jan 2024
pdf
11_10.pdf
( pdf, 1.50 MB )
(3645 downloads)
Popular
02 Jan 2024
pdf
11_11.pdf
( pdf, 307 KB )
(4150 downloads)
Popular
20 Dec 2022
pdf
11_11.pdf
( pdf, 114 KB )
(3076 downloads)
Popular
02 Jan 2024
pdf
11_12.pdf
( pdf, 330 KB )
(3957 downloads)
Popular
26 Jan 2023
pdf
11_12.pdf
( pdf, 148 KB )
(3241 downloads)
Popular
02 Jan 2024
pdf
11_13.pdf
( pdf, 305 KB )
(3120 downloads)
Popular
02 Jan 2024
pdf
11_2.pdf
( pdf, 87 KB )
(4313 downloads)
Popular
02 Jan 2024
«
1
2
3
4
5
…
43
44
»
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
×
