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
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
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
UKK
Loading...
Folder
UKK
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DRAFT GUIDANCE DOCUMENTS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
2 ESubmission New Notification CRU
( pdf, 206 KB )
(2347 downloads)
Popular
25 May 2022
pdf
2 0 Overview Renewal of Product Classification Application
( pdf, 196 KB )
(382 downloads)
Popular
11 Nov 2025
pdf
2. ESubmission New Notification (final).pdf
( pdf, 199 KB )
(4980 downloads)
Popular
28 Feb 2023
pdf
2. ESubmission New Notification CRU.pdf
( pdf, 206 KB )
(3884 downloads)
Popular
29 Mar 2023
pdf
2. PDF - BORANG PERMOHONAN JAWATAN KOSONG BK_UKP_012 VER 1.pdf
( pdf, 115 KB )
(2138 downloads)
Popular
02 Nov 2022
pdf
2020SIRIMLINKISSUE2 Sirim
( pdf, 1.43 MB )
(5795 downloads)
Popular
07 Jan 2021
pdf
20240403_IMDEC 2024_PORTAL MDA.pdf
( pdf, 6.82 MB )
(1310 downloads)
Popular
04 Apr 2024
pdf
20240419_IMDEC2024-PROGRAM BOOK - NORFAZLIN BINTI RASIDI (MDA).pdf
( pdf, 3.46 MB )
(1242 downloads)
Popular
30 Apr 2024
pdf
28 APRIL 2025 DRAFT PUBLIC COMMENT GD SPECIAL ACCESS MEDICAL DEVICE SECOND EDITION.pdf
( pdf, 344 KB )
(3149 downloads)
Popular
28 Apr 2025
pdf
28 OCT 25 Flowchart 2025 New Application
( pdf, 139 KB )
(632 downloads)
Popular
28 Oct 2025
pdf
28 OCT 25 GD of Product Classification 4th Ver 2025
( pdf, 374 KB )
(1168 downloads)
Popular
28 Oct 2025
pdf
3 ESubmission Subsequent Notification
( pdf, 120 KB )
(4364 downloads)
Popular
06 Jul 2022
pdf
3 ESubmission Subsequent Notification CRU
( pdf, 78 KB )
(4803 downloads)
Popular
25 May 2022
pdf
3. Overview of Registration Framework.pdf
( pdf, 270 KB )
(8020 downloads)
Popular
13 Feb 2024
pdf
3a. Registration Process Flow (Class A Medical Device).pdf
( pdf, 89 KB )
(5115 downloads)
Popular
13 Feb 2024
pdf
3b. Registration Process Flow (Class B, C and D Medical Device).pdf
( pdf, 96 KB )
(6428 downloads)
Popular
13 Feb 2024
document
4 CRU Notification For Export Disposal of Devices After Research Completion Termination
( doc, 409 KB )
(5485 downloads)
Popular
25 May 2022
pdf
4 ESubmission New AE Notification
( pdf, 132 KB )
(4454 downloads)
Popular
06 Jul 2022
pdf
4. How to create a MeDC@St account.pdf
( pdf, 367 KB )
(5726 downloads)
Popular
13 Feb 2024
pdf
4. Process Flow for Endorsement Letter for Ancillary Medical Device Component Application.pdf
( pdf, 36 KB )
(1119 downloads)
Popular
18 Oct 2024
«
1
2
3
4
…
19
20
»
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
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
Integrity Information
Training Academy (COE)
Speakers
Registration
Licensing
Comformity Assessment Body (CAB)
Syllabus
Registration
Licensing
Comformity Assessment Body (CAB)
Training Schedule
×