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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DRAFT GUIDANCE DOCUMENTS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
Events
Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
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MDA Staff - Forms
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FCA
UKK
Strategic Plan
INFOGRAPHIC
Pelan Anti Rasuah
Buletin MDA
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
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pdf
MDAGD0043 SpecialAccess 15May2020 60 00
( pdf, 623 KB )
(15519 downloads)
Popular
18 May 2020
pdf
MDAGD0043 SpecialAccess 15May2020 60 00
( pdf, 627 KB )
(22148 downloads)
Popular
29 Nov 2021
pdf
MDAGD0045 CFS for EO MD Nov2018
( pdf, 477 KB )
(9198 downloads)
Popular
29 Nov 2021
pdf
MDA_GD0009_Classification of General Medical Device 2nd Edition_edited Rule1.pdf
( pdf, 1.01 MB )
(13586 downloads)
Popular
21 Nov 2022
pdf
Medical Device - Drugs - Cosmetic Interphase (MDDCI) and Combination Products (Table MDDCI 2025)
( pdf, 425 KB )
(5207 downloads)
Popular
13 Aug 2025
pdf
MEDICAL DEVICE GUIDANCE DOCUMENT
( pdf, 176 KB )
(7107 downloads)
Popular
06 Mar 2018
pdf
Medical Device Recall
( pdf, 686 KB )
(6278 downloads)
Popular
19 Nov 2021
pdf
Medical Device Recall 60 90 2July2020 edited GDAC decision
( pdf, 431 KB )
(13776 downloads)
Popular
02 Jul 2020
pdf
Medical Device Recall 60 90 2July2020 edited GDAC decision
( pdf, 431 KB )
(26235 downloads)
Popular
29 Nov 2021
pdf
Medical Face Mask and Respirator
( pdf, 317 KB )
(7230 downloads)
Popular
19 Nov 2021
pdf
Medical Face Mask and Respirator Third Edition.pdf
( pdf, 317 KB )
(12818 downloads)
Popular
19 May 2023
pdf
Medical face mask Guidelines GDAC Bil 7 2021
( pdf, 312 KB )
(3890 downloads)
Popular
29 Oct 2021
pdf
Medical face mask Guidelines GDAC Bil 7 2021
( pdf, 314 KB )
(8348 downloads)
Popular
29 Nov 2021
pdf
Medical Gas System – Requirements for Registration
( pdf, 547 KB )
(1768 downloads)
Popular
19 Nov 2021
pdf
Medical Gas Systems-Requirements for Registration.pdf
( pdf, 524 KB )
(16245 downloads)
Popular
13 Feb 2023
pdf
Notification Demonstration
( pdf, 771 KB )
(5720 downloads)
Popular
01 Nov 2017
pdf
Notification For Obsolete And Discontinued Medical Device
( pdf, 649 KB )
(3690 downloads)
Popular
19 Nov 2021
pdf
Notification of Custom-made Medical Device - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).pdf
( pdf, 460 KB )
(1478 downloads)
Popular
01 Mar 2023
pdf
Notification of Custom-made Medical Device.pdf
( pdf, 460 KB )
(11137 downloads)
Popular
01 Mar 2023
pdf
Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation
( pdf, 683 KB )
(2995 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
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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