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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DRAFT GUIDANCE DOCUMENTS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)
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- 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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pdf
Mandatory Problem Reporting 60 60 10 june2020 (2)
( pdf, 328 KB )
(29649 downloads)
Popular
29 Nov 2021
pdf
MDA GD 0060 REFURBISHED MEDICAL DEVICE REQUIREMENTS (2)
( pdf, 190 KB )
(7221 downloads)
Popular
04 Feb 2022
pdf
MDA GD 0060 REFURBISHED MEDICAL DEVICE REQUIREMENTS (2)
( pdf, 190 KB )
(2281 downloads)
Popular
08 Feb 2022
pdf
MDA GD0009 Classification of General Medical Device
( pdf, 963 KB )
(39936 downloads)
Popular
09 May 2022
pdf
MDA GD0009 Classification of General Medical Device (1)
( pdf, 961 KB )
(9363 downloads)
Popular
20 May 2022
pdf
MDA GD0026 Requirement on Labelling of MD Post GDAC 28 Oct 2021 v7 Final
( pdf, 343 KB )
(3552 downloads)
Popular
29 Oct 2021
pdf
MDA GD0026 Requirement on Labelling of MD Post GDAC 28 Oct 2021 v7 Final
( pdf, 346 KB )
(11938 downloads)
Popular
29 Nov 2021
pdf
MDA GD0026 REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES
( pdf, 308 KB )
(12126 downloads)
Popular
22 Jun 2022
pdf
MDA GD0059 Requirement on COVID 19 Test KIt Selling Portal
( pdf, 260 KB )
(6066 downloads)
Popular
29 Mar 2022
pdf
MDA GD0059 Requirement on COVID 19 Test KIt Selling SY EDITED NOV2021 v3
( pdf, 282 KB )
(6871 downloads)
Popular
09 Nov 2021
pdf
MDA GD0059 Requirement on COVID 19 Test KIt Selling SY EDITED NOV2021 v3
( pdf, 284 KB )
(11063 downloads)
Popular
29 Nov 2021
pdf
MDA/GD-01 March 2014 First Edition - DEFINITION OF MEDICAL DEVICE
( pdf, 304 KB )
(18771 downloads)
Popular
24 Mar 2014
pdf
MDA/GD-02 March 2014 First Edition - ESSENTIAL PRINCIPLES OF SAFETY & PERFORMANCE OF MEDICAL DEVICE
( pdf, 311 KB )
(17508 downloads)
Popular
24 Mar 2014
pdf
MDA/GD-03 March 2014 First Edition - COMMON SUBMISSION DOSSIER TEMPLATE
( pdf, 442 KB )
(27274 downloads)
Popular
24 Mar 2014
pdf
MDA/GD-04 March 2014 First Edition - THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES
( pdf, 1.86 MB )
(53439 downloads)
Popular
24 Mar 2014
pdf
MDA/GD-05 October 2013 First Edition- GUIDANCE ON THE PRODUCT GROUPING
( pdf, 739 KB )
(32532 downloads)
Popular
13 Dec 2013
pdf
MDAGD0001 IVD risk classification MD 2nd 60 60
( pdf, 361 KB )
(9017 downloads)
Popular
26 Jan 2021
pdf
MDAGD0001 IVD risk classification MD 2nd 60 60
( pdf, 363 KB )
(35926 downloads)
Popular
29 Nov 2021
pdf
MDAGD0020 Change Notification 3rd Ed November 2018
( pdf, 516 KB )
(14820 downloads)
Popular
29 Nov 2021
pdf
MDAGD0033 Medical face mask Guidelines 60 60 18JAN2021 (2)
( pdf, 328 KB )
(20489 downloads)
Popular
19 Jan 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
Integrity Unit
Internal Audit Unit
International and Industry Relations Division
Pre-Market Control Division
Policy and Strategic Planning Division
Post Market Division
Enforcement Division
Management Services Division
Finance Division
Corporate Communication Division
Legal Division
Digital and Information Technology Division
Secretarial Division
Regulatory Transformation Unit
FAQ
Single License Policy Implementation
Registration, Licensing & Enforcement
Labelling of Medical Devices
Technical Evaluation
Contact Us
Customer Complaint Form
Staff Directory
Documents
Legislation
General Directions
Circular Letter
Guidance Document
Guideline
Standard
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
Integrity Information
Training Academy (COE)
Speakers
Registration
Licensing
Comformity Assessment Body (CAB)
Syllabus
Registration
Licensing
Comformity Assessment Body (CAB)
Training Schedule
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