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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DRAFT GUIDANCE DOCUMENTS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
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Awareness Program on Medical Device for Healthcare
Career
MeDC@St
Guideline Documents
GUIDANCE DOCUMENTS
CAB & Establishment
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
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- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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pdf
2011 05 19 11R CoreValve2
( pdf, 377 KB )
(2923 downloads)
Popular
03 Sep 2019
document
2012 01 26 01R RESPIRONICS usfda
( doc, 323 KB )
(3297 downloads)
Popular
03 Sep 2019
Image
2024-MDA-RIS Poster - NUR RASIDAH BT NGASBON (MDA).png
( png, 640 KB )
(63 downloads)
07 Jan 2025
pdf
2a. Global_FSN Letter_FSCA287_2025-01-21 (MDA_FCA_P1197_84272830_2025) (2eBWyvBb).pdf
( pdf )
(254 downloads)
Popular
03 Mar 2025
pdf
3- APPENDIX-2---Medical-Device-Drug-Cosmetic-Interphase-MDDCI-and-Combination-Products.pdf
( pdf, 778 KB )
(1939 downloads)
Popular
28 Feb 2024
pdf
4. Process Flow for Endorsement Letter for Ancillary Medical Device Component Application.pdf
( pdf, 35 KB )
(1008 downloads)
Popular
28 Feb 2024
document
5. Appendix 3 - Application form for endorsement letter of ancillary component for the registration of combination product – Appendix 3 (2).doc
( doc, 233 KB )
(1573 downloads)
Popular
28 Feb 2024
pdf
6 DEF OF MD
( pdf, 442 KB )
(8904 downloads)
Popular
10 May 2019
pdf
6. Overview of Post Approval Changes of a Registered Combination Product (Changes to Ancillary Medical Device Component) Framework.pdf
( pdf, 160 KB )
(1164 downloads)
Popular
28 Feb 2024
pdf
7. Process Flow for Approval Letter for Changes to Ancillary Medical Device Component Application.pdf
( pdf, 35 KB )
(519 downloads)
Popular
28 Feb 2024
document
8a. Appendix 4 - Application form for change variation of ancillary components for combination products – Appendix 4 (2).doc
( doc, 201 KB )
(843 downloads)
Popular
28 Feb 2024
document
8b. Summary table of changes (1).doc
( doc, 92 KB )
(872 downloads)
Popular
28 Feb 2024
pdf
9. Information on Fee Structure for Application of Endorsement Letter and Approval Letter for Post-Approval Changes, of Ancillary Medical Device Component.pdf
( pdf, 38 KB )
(905 downloads)
Popular
28 Feb 2024
pdf
Abbott FSN - Assurity Endurity 2025 - Malaysia v2 (MDA_FCA_P1198_55805208_2025) (YUj5lbco).pdf
( pdf )
(271 downloads)
Popular
03 Mar 2025
pdf
ACCESS AFP (300 TEST KIT).pdf
( pdf, 518 KB )
(171 downloads)
Popular
12 Mar 2024
pdf
ACCESS AFP (300 TEST KIT).pdf
( pdf, 518 KB )
(1009 downloads)
Popular
22 Apr 2024
pdf
ACCESS BONE METABOLISM ASSAYS.pdf
( pdf, 561 KB )
(401 downloads)
Popular
17 Dec 2024
pdf
ACCESS CORTISOL.pdf
( pdf, 393 KB )
(364 downloads)
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17 Dec 2024
pdf
ACCESS HBC AB.pdf
( pdf, 471 KB )
(520 downloads)
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02 Sep 2024
pdf
ACCESS HSTNI.pdf
( pdf, 422 KB )
(470 downloads)
Popular
17 Dec 2024
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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
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