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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DRAFT GUIDANCE DOCUMENTS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
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Customer Satisfaction Survey Report
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pdf
2 ESubmission New Notification CRU
( pdf, 206 KB )
(2164 downloads)
Popular
25 May 2022
pdf
2. ESubmission New Notification (final).pdf
( pdf, 199 KB )
(4255 downloads)
Popular
28 Feb 2023
pdf
2. ESubmission New Notification CRU.pdf
( pdf, 206 KB )
(3086 downloads)
Popular
29 Mar 2023
pdf
2. PDF - BORANG PERMOHONAN JAWATAN KOSONG BK_UKP_012 VER 1.pdf
( pdf, 115 KB )
(1999 downloads)
Popular
02 Nov 2022
pdf
2020SIRIMLINKISSUE2 Sirim
( pdf, 1.43 MB )
(5420 downloads)
Popular
07 Jan 2021
pdf
20240403_IMDEC 2024_PORTAL MDA.pdf
( pdf, 6.82 MB )
(1167 downloads)
Popular
04 Apr 2024
pdf
20240419_IMDEC2024-PROGRAM BOOK - NORFAZLIN BINTI RASIDI (MDA).pdf
( pdf, 3.46 MB )
(1091 downloads)
Popular
30 Apr 2024
pdf
28 APRIL 2025 DRAFT PUBLIC COMMENT GD SPECIAL ACCESS MEDICAL DEVICE SECOND EDITION.pdf
( pdf, 344 KB )
(1290 downloads)
Popular
28 Apr 2025
pdf
3 ESubmission Subsequent Notification
( pdf, 120 KB )
(3644 downloads)
Popular
06 Jul 2022
pdf
3 ESubmission Subsequent Notification CRU
( pdf, 78 KB )
(4081 downloads)
Popular
25 May 2022
pdf
3. Overview of Registration Framework.pdf
( pdf, 270 KB )
(5427 downloads)
Popular
13 Feb 2024
pdf
3a. Registration Process Flow (Class A Medical Device).pdf
( pdf, 89 KB )
(4802 downloads)
Popular
13 Feb 2024
pdf
3b. Registration Process Flow (Class B, C and D Medical Device).pdf
( pdf, 96 KB )
(5696 downloads)
Popular
13 Feb 2024
document
4 CRU Notification For Export Disposal of Devices After Research Completion Termination
( doc, 409 KB )
(4708 downloads)
Popular
25 May 2022
pdf
4 ESubmission New AE Notification
( pdf, 132 KB )
(3688 downloads)
Popular
06 Jul 2022
pdf
4. How to create a MeDC@St account.pdf
( pdf, 367 KB )
(4753 downloads)
Popular
13 Feb 2024
pdf
4. Process Flow for Endorsement Letter for Ancillary Medical Device Component Application.pdf
( pdf, 36 KB )
(682 downloads)
Popular
18 Oct 2024
pdf
4a. User Manual MDR A Front End User.pdf
( pdf, 7.18 MB )
(1152 downloads)
Popular
13 Feb 2024
pdf
4b. User Manual MDR BCD Front End User.pdf
( pdf, 5.85 MB )
(3405 downloads)
Popular
13 Feb 2024
pdf
5 JKTPP Schedule Planner 2022
( pdf, 105 KB )
(2214 downloads)
Popular
25 May 2022
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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
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