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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DRAFT GUIDANCE DOCUMENTS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
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Guideline Documents
GUIDANCE DOCUMENTS
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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pdf
(approved) Guideline Advertisement update on Januari 2022 v2 (1)
( pdf, 374 KB )
(2990 downloads)
Popular
08 Feb 2022
pdf
(approved) Guideline Advertisement update on Januari 2022 v2 (2)
( pdf, 281 KB )
(25199 downloads)
Popular
23 Feb 2022
document
APPENDIX 3 ii Application form for change variation of ancillary components for combination products – Appendix 4
( doc, 233 KB )
(1193 downloads)
Popular
22 Oct 2021
document
APPENDIX 4 Application form for change variation of ancillary components for combination products – Appendix 4
( doc, 201 KB )
(1131 downloads)
Popular
22 Oct 2021
pdf
APPLICATION FOR RENEWAL OF ESTABLISHMENT LICENSE
( pdf, 294 KB )
(14978 downloads)
Popular
24 May 2017
document
Application form for change variation of ancillary components for combination products – Appendix 4 (1)
( doc, 201 KB )
(1281 downloads)
Popular
25 Oct 2021
document
Application form for endorsement letter of ancillary component for the registration of combination product – Appendix 3
( doc, 233 KB )
(1603 downloads)
Popular
25 Oct 2021
document
Checklist for submission of ancillary medical device component
( doc, 101 KB )
(4315 downloads)
Popular
25 Oct 2021
document
Checklist iii for submission of ancillary medical device component
( doc, 101 KB )
(2271 downloads)
Popular
22 Oct 2021
pdf
Draft GL Monkeypox 05092022 pdf
( pdf, 303 KB )
(6951 downloads)
Popular
14 Sep 2022
pdf
FAQs on Drug Medical Device Combination Product Updated 4th October 2021
( pdf, 174 KB )
(5717 downloads)
Popular
22 Oct 2021
pdf
Fifth Edition Guideline for Medical Device- Drug and Drug-Medical Device Combination Product (Final).pdf
( pdf, 1.22 MB )
(15581 downloads)
Popular
11 Jan 2023
pdf
GL Covid19 2nd Edition (Published)
( pdf, 582 KB )
(2193 downloads)
Popular
25 Apr 2022
pdf
GL Registration Covid 19 IVD Test Kits Published
( pdf, 601 KB )
(10612 downloads)
Popular
25 Jan 2022
pdf
Guidance Document Placement of HIV Self-test kit in Malaysia Market First Edition (1).pdf
( pdf, 630 KB )
(2821 downloads)
Popular
19 Feb 2024
pdf
Guideline APPLICATION FOR MEDICAL DEVICE ADVERTISEMENT APPROVAL REQUIREMENTS 12 April 2021 v1
( pdf, 431 KB )
(11509 downloads)
Popular
13 Apr 2021
pdf
GUIDELINE CONDITIONAL APPROVAL FOR COVID 19 RTK SELF TEST 120821 v6
( pdf, 1.39 MB )
(22542 downloads)
Popular
12 Aug 2021
pdf
Guideline CP 19 12 19 updated
( pdf, 1.54 MB )
(8483 downloads)
Popular
23 Dec 2019
pdf
Guideline for CAB on Re-Registration of Registered Medical Device (First Edition)
( pdf, 215 KB )
(5185 downloads)
Popular
05 Jun 2024
pdf
Guideline For Re-Registration Of Registered Medical Device - NUR NAJIHA BINTI SAARANI (MDA).pdf
( pdf, 326 KB )
(983 downloads)
Popular
08 Jun 2023
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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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