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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DRAFT GUIDANCE DOCUMENTS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)
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
Complaint Handling
( pdf, 260 KB )
(5274 downloads)
Popular
19 Nov 2021
pdf
Complaint Handling 60 60 23JUN2020
( pdf, 248 KB )
(12666 downloads)
Popular
23 Jun 2020
pdf
Complaint Handling 60 60 23JUN2020
( pdf, 251 KB )
(16017 downloads)
Popular
29 Nov 2021
pdf
Conformity Assessment Body (CAB) Requirement for Registration
( pdf, 981 KB )
(5312 downloads)
Popular
19 Nov 2021
pdf
Conformity Assessment for IVD Medical Devices
( pdf, 415 KB )
(11273 downloads)
Popular
24 Oct 2013
pdf
Conformity Assessment for Medical Device
( pdf, 574 KB )
(5482 downloads)
Popular
19 Nov 2021
pdf
Definition of Medical Device
( pdf, 225 KB )
(3387 downloads)
Popular
16 Nov 2021
pdf
DEMO LIST UPDATED ON 29 05 2019
( pdf, 755 KB )
(2583 downloads)
Popular
30 May 2019
pdf
Distribution Records
( pdf, 229 KB )
(2703 downloads)
Popular
19 Nov 2021
pdf
Distribution Records 60 60 3june2020 (1)
( pdf, 253 KB )
(9787 downloads)
Popular
15 Jun 2020
pdf
Distribution Records 60 60 3june2020 (1)
( pdf, 255 KB )
(13362 downloads)
Popular
29 Nov 2021
pdf
Draf Public Comment GD 0027 Licencing for Establishment
( pdf, 614 KB )
(4559 downloads)
Popular
08 Jun 2022
pdf
Draft Guidance document Conformity Assessment for medical device
( pdf, 883 KB )
(9157 downloads)
Popular
26 May 2017
pdf
Essential Principles of Safety and Performance for IVD Medical Devices
( pdf, 348 KB )
(11535 downloads)
Popular
24 Oct 2013
pdf
Essential Principles of Safety and Performance of IVD Medical Devices
( pdf, 282 KB )
(2717 downloads)
Popular
16 Nov 2021
pdf
Field Corrective Action (FCA)
( pdf, 312 KB )
(5501 downloads)
Popular
19 Nov 2021
pdf
Field Corrective Action GDAC 29JUNE2020 SYEdited
( pdf, 336 KB )
(12724 downloads)
Popular
30 Jun 2020
pdf
Field Corrective Action GDAC 29JUNE2020 SYEdited (1)
( pdf, 338 KB )
(18302 downloads)
Popular
29 Nov 2021
pdf
Final MDA.GD.0018 IMPORT ANDOR SUPPLY OF UNREGISTERED MEDICAL DEVICES FOR THE PURPOSE OF DEMONSTRATI
( pdf, 789 KB )
(4156 downloads)
Popular
01 Mar 2018
pdf
GD 0058 PERSONAL PROTECTIVE EQUIPMENT (PPE) REQUIREMENTS
( pdf, 382 KB )
(1576 downloads)
Popular
27 May 2022
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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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