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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DRAFT GUIDANCE DOCUMENTS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
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pdf
Possible Way of Registering Culture Media.pdf
( pdf, 147 KB )
(2782 downloads)
Popular
23 Feb 2024
document
Post Handling SA.doc
( doc, 367 KB )
(4208 downloads)
Popular
01 Sep 2023
pdf
PPT Statistik Unit Pelesenan Jan-Dis 2024.pdf
( pdf, 1002 KB )
(1892 downloads)
Popular
09 May 2025
pdf
PRESS RELEASE MDA CHINA LATEST
( pdf, 93 KB )
(2103 downloads)
Popular
31 Jul 2025
document
Product Classification Application Form 2023.docx
( docx, 77 KB )
(1361 downloads)
Popular
22 Feb 2023
document
Product Classification Application Form 2024.docx
( docx, 95 KB )
(4035 downloads)
Popular
30 Jul 2024
pdf
Program 2_GDPMD .pdf
( pdf, 685 KB )
(3164 downloads)
Popular
15 Mar 2024
pdf
PROGRAM 7 POST-MARKET .pdf
( pdf, 3.35 MB )
(1061 downloads)
Popular
13 Jun 2024
pdf
PROGRAM 8 HANDS- ON (MEDCREST) POST-MARKET .pdf
( pdf, 11.53 MB )
(1197 downloads)
Popular
13 Jun 2024
pdf
PROGRAM 8 POST-MARKET .pdf
( pdf, 3.26 MB )
(528 downloads)
Popular
12 Jun 2024
pdf
PROGRAM 9 HANDS- ON (MEDCREST) POST-MARKET .pdf
( pdf, 11.53 MB )
(637 downloads)
Popular
12 Jun 2024
pdf
PROGRAM 9 IN DEPTH TRAINING ON IN-VITRO DIAGNOSTIC .pdf
( pdf, 665 KB )
(1157 downloads)
Popular
12 Jun 2024
pdf
PUA 330 2025 (2)
( pdf, 178 KB )
(6221 downloads)
Popular
14 Oct 2025
pdf
PUA10 MEDICAL DEVICE (DESIGNATED MEDICAL DEVICE) ORDER 2026
( pdf, 362 KB )
(2960 downloads)
Popular
13 Jan 2026
pdf
Public Comment GD Application for Confirmation Status of Orphaned Medical Device docx ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA)
( pdf, 455 KB )
(1653 downloads)
Popular
16 Oct 2025
pdf
Public Comment GD Change Management for Registered Medical Device
( pdf, 1.73 MB )
(3326 downloads)
Popular
03 Dec 2025
pdf
PUBLIC COMMENT GD DEFINITION OF MEDICAL DEVICE SECOND EDITION
( pdf, 246 KB )
(3002 downloads)
Popular
04 Dec 2025
pdf
PUBLIC COMMENT GD LABELLING REQUIREMENTS FOR MEDICAL DEVICE DRAFT 7TH EDITION docx
( pdf, 368 KB )
(3129 downloads)
Popular
15 Oct 2025
pdf
PUBLIC COMMENT GD OBSOLETE AND DISCONTINUED FIRST EDITION docx
( pdf, 673 KB )
(1760 downloads)
Popular
16 Oct 2025
document
Regulatory Feedback Form - SABAH.docx
( docx, 23 KB )
(831 downloads)
Popular
11 Sep 2023
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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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