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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DRAFT GUIDANCE DOCUMENTS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
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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UKK
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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 )
(2397 downloads)
Popular
19 Nov 2021
pdf
Guidance Document Personal Protective Equipment (PPE) Requirements
( pdf, 376 KB )
(6377 downloads)
Popular
19 Nov 2021
pdf
Guidance Document Placement of HIV Self-test kit in Malaysia Market First Edition.pdf
( pdf, 630 KB )
(5489 downloads)
Popular
19 Feb 2024
pdf
Guidance Document Product Grouping Second Edition - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).pdf
( pdf, 516 KB )
(18500 downloads)
Popular
30 Jan 2024
pdf
Guidance Document Requirement for Export Permit Final
( pdf, 765 KB )
(6433 downloads)
Popular
01 Jun 2017
pdf
Guidance Document Special Access Notification General Requirements
( pdf, 765 KB )
(2978 downloads)
Popular
19 Nov 2021
pdf
Guidance Document_Declaration of Conformity _3 feb 2016
( pdf, 331 KB )
(17580 downloads)
Popular
03 Feb 2016
pdf
Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combinations Products
( pdf, 1.03 MB )
(4346 downloads)
Popular
14 Apr 2018
pdf
HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 (ACT 737)
( pdf, 1.12 MB )
(16681 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 )
(15705 downloads)
Popular
19 Nov 2021
pdf
IMPORT ANDOR SUPPLY OF UNREGISTERED MEDICAL DEVICES FOR THE PURPOSE OF DEMONSTRATION FOR MARKETING O
( pdf, 749 KB )
(5034 downloads)
Popular
06 Mar 2018
pdf
In Vitro Diagnostic (IVD) Medical Device Classification System
( pdf, 410 KB )
(3360 downloads)
Popular
16 Nov 2021
pdf
IVD Medical Device Classification System
( pdf, 382 KB )
(16373 downloads)
Popular
24 Oct 2013
pdf
LICENSING FOR ESTABLISHMENT
( pdf, 548 KB )
(16763 downloads)
Popular
25 May 2016
pdf
Licensing for Establishment
( pdf, 520 KB )
(2687 downloads)
Popular
16 Nov 2021
pdf
Mandatory Problem Reporting
( pdf, 344 KB )
(5917 downloads)
Popular
19 Nov 2021
pdf
Mandatory Problem Reporting 60 60 10 june2020
( pdf, 322 KB )
(7822 downloads)
Popular
12 Jun 2020
pdf
Mandatory Problem Reporting 60 60 10 june2020 (2)
( pdf, 326 KB )
(10955 downloads)
Popular
17 Aug 2020
pdf
Mandatory Problem Reporting 60 60 10 june2020 (2)
( pdf, 328 KB )
(23591 downloads)
Popular
29 Nov 2021
pdf
MDA GD 0060 REFURBISHED MEDICAL DEVICE REQUIREMENTS (2)
( pdf, 190 KB )
(5550 downloads)
Popular
04 Feb 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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