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GUIDANCE DOCUMENTS
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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DRAFT GUIDANCE DOCUMENTS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
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
Product Classification
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FCA
UKK
Strategic Plan
INFOGRAPHIC
- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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Date
pdf
Guidance Document on Notification of Export Only Medical Device
( pdf, 332 KB )
(2479 downloads)
Popular
19 Nov 2021
pdf
Guidance Document Personal Protective Equipment (PPE) Requirements
( pdf, 376 KB )
(6584 downloads)
Popular
19 Nov 2021
pdf
Guidance Document Placement of HIV Self-test kit in Malaysia Market First Edition.pdf
( pdf, 630 KB )
(5607 downloads)
Popular
19 Feb 2024
pdf
Guidance Document Product Grouping Second Edition - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).pdf
( pdf, 516 KB )
(19415 downloads)
Popular
30 Jan 2024
pdf
Guidance Document Requirement for Export Permit Final
( pdf, 765 KB )
(6490 downloads)
Popular
01 Jun 2017
pdf
Guidance Document Special Access Notification General Requirements
( pdf, 765 KB )
(3050 downloads)
Popular
19 Nov 2021
pdf
Guidance Document_Declaration of Conformity _3 feb 2016
( pdf, 331 KB )
(17619 downloads)
Popular
03 Feb 2016
pdf
Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combinations Products
( pdf, 1.03 MB )
(4385 downloads)
Popular
14 Apr 2018
pdf
Guideline on How to Apply for Product Classification Application (GD of Product Classification 4th Ver 2025)
( pdf, 374 KB )
(117 downloads)
New
Popular
13 Aug 2025
pdf
HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 (ACT 737)
( pdf, 1.12 MB )
(17803 downloads)
Popular
02 Jan 2024
pdf
Import And or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education
( pdf, 460 KB )
(16238 downloads)
Popular
19 Nov 2021
pdf
IMPORT ANDOR SUPPLY OF UNREGISTERED MEDICAL DEVICES FOR THE PURPOSE OF DEMONSTRATION FOR MARKETING O
( pdf, 749 KB )
(5085 downloads)
Popular
06 Mar 2018
pdf
In Vitro Diagnostic (IVD) Medical Device Classification System
( pdf, 410 KB )
(3482 downloads)
Popular
16 Nov 2021
pdf
IVD Medical Device Classification System
( pdf, 382 KB )
(16450 downloads)
Popular
24 Oct 2013
pdf
LICENSING FOR ESTABLISHMENT
( pdf, 548 KB )
(16865 downloads)
Popular
25 May 2016
pdf
Licensing for Establishment
( pdf, 520 KB )
(2786 downloads)
Popular
16 Nov 2021
pdf
Mandatory Problem Reporting
( pdf, 344 KB )
(6194 downloads)
Popular
19 Nov 2021
pdf
Mandatory Problem Reporting 60 60 10 june2020
( pdf, 322 KB )
(7874 downloads)
Popular
12 Jun 2020
pdf
Mandatory Problem Reporting 60 60 10 june2020 (2)
( pdf, 326 KB )
(11097 downloads)
Popular
17 Aug 2020
pdf
Mandatory Problem Reporting 60 60 10 june2020 (2)
( pdf, 328 KB )
(24207 downloads)
Popular
29 Nov 2021
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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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