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recall
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DRAFT GUIDANCE DOCUMENTS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
Product Classification
MDA Staff - Forms
Training Programme
FCA
UKK
Strategic Plan
INFOGRAPHIC
- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
Buletin MDA
Contoh Kategori Docman
Press Release
MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
Pekeliling Kerajaan
Customer Satisfaction Survey Report
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Date
pdf
1 IVD MEDICAL DEVICE CLASSIFICATION SYSTEM
( pdf, 556 KB )
(18089 downloads)
Popular
14 Apr 2018
pdf
16 Notification for Clinical Research or Performance evaluation
( pdf, 1.58 MB )
(11728 downloads)
Popular
14 Apr 2018
pdf
16 Notification for Clinical Research or Performance evaluation
( pdf, 1.58 MB )
(14003 downloads)
Popular
29 Nov 2021
pdf
18 Notification Demonstration
( pdf, 913 KB )
(6506 downloads)
Popular
14 Apr 2018
pdf
190220 GDAC 3 Requirement CAB To Publish
( pdf, 1.34 MB )
(12801 downloads)
Popular
07 Sep 2020
pdf
190220 GDAC 3 Requirement CAB To Publish
( pdf, 1.34 MB )
(13268 downloads)
Popular
30 Nov 2021
pdf
2 EPSP OF IVD MEDICAL DEVICES
( pdf, 497 KB )
(16440 downloads)
Popular
14 Apr 2018
pdf
2 EPSP OF IVD MEDICAL DEVICES
( pdf, 499 KB )
(10086 downloads)
Popular
29 Nov 2021
pdf
20 Change Notification Scope
( pdf, 871 KB )
(5148 downloads)
Popular
14 Apr 2018
pdf
20191121 GD Notification Demonstration
( pdf, 380 KB )
(16384 downloads)
Popular
07 Jan 2020
pdf
20191121 GD Notification Demonstration
( pdf, 383 KB )
(2374 downloads)
Popular
29 Nov 2021
pdf
202012 GD IVD Product Grouping MDAGD0054
( pdf, 1.16 MB )
(2605 downloads)
Popular
28 Mar 2022
pdf
202012 GD IVD Product Grouping MDAGD0054 (1)
( pdf, 1.81 MB )
(8585 downloads)
Popular
15 Apr 2021
pdf
202012 GD IVD Product Grouping MDAGD0054 (1)
( pdf, 1.82 MB )
(3699 downloads)
Popular
30 Nov 2021
pdf
24 Requirement for Export Permit
( pdf, 648 KB )
(7107 downloads)
Popular
14 Apr 2018
pdf
24 Requirement for Export Permit
( pdf, 651 KB )
(11264 downloads)
Popular
29 Nov 2021
pdf
25 Declaration of Conformity
( pdf, 478 KB )
(28953 downloads)
Popular
14 Apr 2018
pdf
25 Declaration of Conformity
( pdf, 480 KB )
(26472 downloads)
Popular
29 Nov 2021
pdf
26 Requirement on Labelling of MD
( pdf, 608 KB )
(5560 downloads)
Popular
14 Apr 2018
pdf
27 Licensing for establishment
( pdf, 746 KB )
(36999 downloads)
Popular
14 Apr 2018
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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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