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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DRAFT GUIDANCE DOCUMENTS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)
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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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MeDC@St
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
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pdf
GD_Code of Advertisement COA_8 April 2021_v2.1.pdf
( pdf, 402 KB )
(14806 downloads)
Popular
19 Dec 2022
pdf
Good Distribution Practice for Medical Devices (GDPMD)
( pdf, 384 KB )
(18295 downloads)
Popular
16 Nov 2021
pdf
Good Refurbishment Practice of Medical Devices (GRPMD)
( pdf, 290 KB )
(3922 downloads)
Popular
16 Nov 2021
pdf
GRPMD
( pdf, 392 KB )
(10060 downloads)
Popular
30 Jan 2016
pdf
GUIDANCE DOCUMENT CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICE 4TH EDITION_FINAL-Cat3 change.pdf
( pdf, 495 KB )
(46327 downloads)
Popular
23 Dec 2022
pdf
GUIDANCE DOCUMENT CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICE 4TH EDITION_FINAL.pdf
( pdf, 495 KB )
(8447 downloads)
Popular
21 Nov 2022
pdf
Guidance document Conformity Assessment for medical device
( pdf, 655 KB )
(11515 downloads)
Popular
22 Aug 2017
pdf
Guidance Document COVID 19 RTK (SELF TEST) REQUIREMENTS
( pdf, 258 KB )
(3795 downloads)
Popular
19 Nov 2021
pdf
Guidance Document Harmonised Borderline Products in ASEAN
( pdf, 442 KB )
(10561 downloads)
Popular
05 Sep 2022
pdf
GUIDANCE DOCUMENT HARMONISED BORDERLINE PRODUCTS IN ASEAN
( pdf, 477 KB )
(9640 downloads)
Popular
25 Dec 2023
pdf
Guidance Document Harmonised Classification of Medical Device
( pdf, 360 KB )
(13615 downloads)
Popular
05 Sep 2022
pdf
GUIDANCE DOCUMENT HARMONISED CLASSIFICATION OF MEDICAL DEVICES IN ASEAN
( pdf, 471 KB )
(8435 downloads)
Popular
25 Dec 2023
pdf
Guidance Document Importation of Medical Device for Personal Use First Edition - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA) (1).pdf
( pdf, 276 KB )
(521 downloads)
Popular
05 Feb 2024
pdf
Guidance Document Importation of Medical Device for Personal Use First Edition.pdf
( pdf, 276 KB )
(10858 downloads)
Popular
05 Feb 2024
pdf
Guidance Document Importation of Medical Device for Personal Use-FINAL - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).pdf
( pdf, 276 KB )
(4019 downloads)
Popular
30 Jan 2024
pdf
GUIDANCE DOCUMENT LABELLING REQUIREMENTS FOR MEDICAL DEVICE 6TH EDITION FINAL.pdf
( pdf, 311 KB )
(11679 downloads)
Popular
21 Nov 2022
pdf
GUIDANCE DOCUMENT LABELLING REQUIREMENTS FOR MEDICAL DEVICE 6TH EDITION FINAL.pdf
( pdf, 311 KB )
(28329 downloads)
Popular
22 Nov 2022
pdf
GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT SECOND EDITION
( pdf, 528 KB )
(38592 downloads)
Popular
23 Sep 2022
pdf
GUIDANCE DOCUMENT MEDICAL DEVICE POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES FIRST EDITION - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).pdf
( pdf, 234 KB )
(8689 downloads)
Popular
30 Jan 2024
pdf
Guidance Document on Notification for Orphaned Medical Device
( pdf, 545 KB )
(2298 downloads)
Popular
19 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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