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
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
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
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DRAFT GUIDANCE DOCUMENTS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
Customer Satisfaction Survey Report
Search
Reset
Toggle
Title
Date
pdf
SA TomotherapyAugust01
( pdf, 41 KB )
(2756 downloads)
Popular
04 Sep 2019
pdf
SA TomotherapyP A
( pdf, 84 KB )
(2729 downloads)
Popular
04 Sep 2019
pdf
SA TomotherapyP B
( pdf, 76 KB )
(2862 downloads)
Popular
04 Sep 2019
pdf
Safety Notice slow increase of etCO2 curve EN (MDA FCA P1297 87763122 2025) (h7zS5RJg)
( pdf, 208 KB )
(194 downloads)
Popular
03 Jun 2025
pdf
Safety Notice slow increase of etCO2 curve EN (MDA FCA P1298 71839518 2025) (R0T2t3di)
( pdf, 208 KB )
(190 downloads)
Popular
03 Jun 2025
pdf
Scan10042025 (MDA_FCA_P1258_34098024_2025) (GdRrjT8R).pdf
( pdf, 1.44 MB )
(325 downloads)
Popular
05 May 2025
pdf
Scan10042025-2 (MDA_FCA_P1256_45172325_2025) (5TxZ7thw).pdf
( pdf, 1.42 MB )
(276 downloads)
Popular
05 May 2025
pdf
SCRTECHS 0506 v2 ID NOW Customer Field Safety Notice Malaysia ENGLISH (MDA FCA P1294 70368681 2025) (h1Hpgw2V)
( pdf, 319 KB )
(187 downloads)
Popular
03 Jun 2025
document
Smiths medical
( doc, 326 KB )
(3378 downloads)
Popular
05 Sep 2019
pdf
Smiths medical01
( pdf, 110 KB )
(3353 downloads)
Popular
05 Sep 2019
pdf
Smiths medical02
( pdf, 28 KB )
(3349 downloads)
Popular
05 Sep 2019
pdf
Smiths medical03
( pdf, 33 KB )
(3734 downloads)
Popular
05 Sep 2019
pdf
Smiths medical04
( pdf, 18 KB )
(2826 downloads)
Popular
05 Sep 2019
pdf
Smiths medical05
( pdf, 34 KB )
(2843 downloads)
Popular
05 Sep 2019
pdf
Specificity issues in Post-Mortem Specimens – Liaison® Anti-HBcLiaison Anti-HBc, product code 310130.pdf
( pdf, 139 KB )
(577 downloads)
Popular
05 Feb 2025
document
Thermofisher
( doc, 323 KB )
(3272 downloads)
Popular
05 Sep 2019
pdf
Thermofisher01
( pdf, 83 KB )
(3172 downloads)
Popular
05 Sep 2019
pdf
Thermofisher02
( pdf, 86 KB )
(2950 downloads)
Popular
05 Sep 2019
pdf
Thermofisher03
( pdf, 44 KB )
(2949 downloads)
Popular
05 Sep 2019
pdf
Thermofisher04
( pdf, 166 KB )
(2968 downloads)
Popular
05 Sep 2019
«
1
2
…
32
33
34
35
»
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
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
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
×
