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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DRAFT GUIDANCE DOCUMENTS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
Regulation
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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UKK
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- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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pdf
Faq reregistration 20220602
( pdf, 110 KB )
(2879 downloads)
Popular
03 Jun 2022
pdf
FAQ.pdf
( pdf, 115 KB )
(5010 downloads)
Popular
21 Feb 2024
pdf
FAQs BERKENAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN.pdf
( pdf, 154 KB )
(3057 downloads)
Popular
09 Sep 2024
pdf
FINAL GD Placement of HIV Self-test Kit in Malaysia Market 2nd Edition (2).pdf
( pdf, 341 KB )
(1024 downloads)
Popular
03 Feb 2025
pdf
FINAL GD Placement of HIV Self-test Kit in Malaysia Market 2nd Edition.pdf
( pdf, 341 KB )
(1299 downloads)
Popular
31 Jan 2025
Image
Flowchart 2023.JPG
( jpg, 49 KB )
(608 downloads)
Popular
22 Feb 2023
pdf
Funding Opportunities for Medical Device Industry in Malaysia.pdf
( pdf, 492 KB )
(1345 downloads)
Popular
08 Nov 2024
pdf
GD of Product Classification 3rd Ver 2024.pdf
( pdf, 370 KB )
(6417 downloads)
Popular
30 Jul 2024
pdf
GD of Product Classification Second Vers 2023.pdf
( pdf, 596 KB )
(6505 downloads)
Popular
22 Feb 2023
pdf
GD PLACEMENT OF HIVST IN MALAYSIA MARKET FIRST EDITION.pdf
( pdf, 630 KB )
(3198 downloads)
Popular
28 Aug 2023
pdf
GD PUBLIC COMMENT CFS, MC AND CFS EO.pdf
( pdf, 606 KB )
(2558 downloads)
Popular
23 Dec 2022
pdf
GD_Code of Advertisement COA 25 7 2023.pdf
( pdf, 374 KB )
(872 downloads)
Popular
25 Jul 2023
pdf
GD_Code of Advertisement COA_8 April 2021_v2.1 (1).pdf
( pdf, 402 KB )
(1096 downloads)
Popular
19 Mar 2025
pdf
GUIDANCE DOCUMENT CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICE 4TH EDITION_FINAL-Cat3 change.pdf
( pdf, 495 KB )
(6023 downloads)
Popular
21 Feb 2024
pdf
Guidance Document Importation of Medical Device for Re-export (IRE) First Edition (1).pdf
( pdf, 533 KB )
(2565 downloads)
Popular
13 Mar 2025
pdf
Guidance Document Importation of Medical Device for Re-export (IRE) First Edition.pdf
( pdf, 523 KB )
(715 downloads)
Popular
11 Mar 2025
pdf
GUIDELINE CONDITIONAL APPROVAL FOR COVID 19 RTK SELF TEST 290721 v5 (1)
( pdf, 598 KB )
(3931 downloads)
Popular
03 Aug 2021
pdf
Guideline of Product Classification DRAFT 2 0 (without Annex B)
( pdf, 501 KB )
(4562 downloads)
Popular
09 Mar 2022
pdf
Hands On Workshop
( pdf )
(3497 downloads)
Popular
18 Feb 2022
pdf
HEBAHAN MEDIA - KENYATAAN MEDIA PENCAPAIAN MDA 2023 - 2024.pdf
( pdf, 188 KB )
(499 downloads)
Popular
10 Feb 2025
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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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