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DRAFT GUIDANCE DOCUMENTS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
FMI 34142 Customer Letter (MDA_FCA_P1251_86707162_2025) (bVeQ9MK0).pdf
( pdf )
(30 downloads)
05 May 2025
pdf
FMI 34142 Customer Letter (MDA_FCA_P1252_92049677_2025) (uWwP1EOb).pdf
( pdf )
(35 downloads)
05 May 2025
pdf
FMI 38016_FSN (MDA_FCA_P1279_20157066_2025) (x7otOIrA).pdf
( pdf )
(81 downloads)
05 May 2025
pdf
FMI 38016_FSN (MDA_FCA_P1280_75147006_2025) (7VpVllru).pdf
( pdf )
(78 downloads)
05 May 2025
pdf
FMI 38017_FSN (MDA_FCA_P1281_19211452_2025) (EQiftP2X).pdf
( pdf )
(78 downloads)
05 May 2025
pdf
FMI 38017_FSN (MDA_FCA_P1282_91662220_2025) (ehqcrCoP).pdf
( pdf )
(76 downloads)
05 May 2025
document
Fnp1
( doc, 757 KB )
(2853 downloads)
Popular
05 Sep 2019
document
Fnp2
( doc, 555 KB )
(2365 downloads)
Popular
05 Sep 2019
pdf
Fnp3
( pdf, 569 KB )
(3847 downloads)
Popular
05 Sep 2019
pdf
FSN FA-25031 Malaysia (MDA_FCA_P1263_61210361_2025) (wEVxEIHY).pdf
( pdf )
(77 downloads)
05 May 2025
pdf
FSN P074
( pdf, 470 KB )
(3379 downloads)
Popular
20 Sep 2021
pdf
FSN P075
( pdf, 1.29 MB )
(3135 downloads)
Popular
20 Sep 2021
pdf
FSN P077
( pdf, 199 KB )
(3250 downloads)
Popular
20 Sep 2021
pdf
FSN P078
( pdf, 821 KB )
(2933 downloads)
Popular
20 Sep 2021
pdf
FSN P078
( pdf, 203 KB )
(1733 downloads)
Popular
22 Sep 2021
pdf
FSN P079
( pdf, 307 KB )
(3198 downloads)
Popular
20 Sep 2021
pdf
FSN P080
( pdf, 269 KB )
(3021 downloads)
Popular
20 Sep 2021
pdf
FSN P081
( pdf, 328 KB )
(3213 downloads)
Popular
20 Sep 2021
pdf
FSN P082
( pdf, 203 KB )
(2847 downloads)
Popular
20 Sep 2021
pdf
FSN P083
( pdf, 182 KB )
(3347 downloads)
Popular
20 Sep 2021
«
1
2
…
23
24
25
26
27
…
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
×