Our Hotline
+603 - 8230 0300
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
Search
fas fa-search
Home
Documents
GUIDANCE DOCUMENTS
Loading...
Folder
GUIDANCE DOCUMENTS
Documents
Search for documents
Find by title or description…
Category
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DRAFT GUIDANCE DOCUMENTS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
Pelan Anti Rasuah
Buletin MDA
Contoh Kategori Docman
Press Release
MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
Pekeliling Kerajaan
Customer Satisfaction Survey Report
Integrity Information
Training Academy (COE)
Search
Reset
Toggle
Title
Date
pdf
27 Licensing for establishment
( pdf, 748 KB )
(11179 downloads)
Popular
29 Nov 2021
pdf
29 GRPMD
( pdf, 550 KB )
(10445 downloads)
Popular
14 Apr 2018
pdf
29 GRPMD
( pdf, 552 KB )
(12831 downloads)
Popular
29 Nov 2021
pdf
3 PRINCIPLES OF CONFORMITY ASSESSMENT FOR IVD MEDICAL DEVICES
( pdf, 590 KB )
(10298 downloads)
Popular
14 Apr 2018
pdf
3 PRINCIPLES OF CONFORMITY ASSESSMENT FOR IVD MEDICAL DEVICES
( pdf, 592 KB )
(13402 downloads)
Popular
29 Nov 2021
pdf
31 Conformity Assessment for Medical Device
( pdf, 896 KB )
(38933 downloads)
Popular
14 Apr 2018
pdf
31 Conformity Assessment for Medical Device
( pdf, 899 KB )
(29185 downloads)
Popular
29 Nov 2021
pdf
310120 [First Edition] NOTIFICATION OF LISTING FOR ORPHANED MEDICAL DEVICE
( pdf, 522 KB )
(6541 downloads)
Popular
25 Feb 2020
pdf
310120 [First Edition] NOTIFICATION OF LISTING FOR ORPHANED MEDICAL DEVICE
( pdf, 524 KB )
(5037 downloads)
Popular
30 Nov 2021
pdf
4 CSDT OF IVD MEDICAL DEVICE
( pdf, 589 KB )
(15835 downloads)
Popular
14 Apr 2018
pdf
4 CSDT OF IVD MEDICAL DEVICE
( pdf, 591 KB )
(27057 downloads)
Popular
29 Nov 2021
pdf
41 CHANGE OWNERSHIP FOR MD REGISTRATION
( pdf, 784 KB )
(10051 downloads)
Popular
14 Apr 2018
pdf
41 CHANGE OWNERSHIP FOR MD REGISTRATION
( pdf, 786 KB )
(23440 downloads)
Popular
29 Nov 2021
pdf
5 Product Grouping
( pdf, 782 KB )
(33078 downloads)
Popular
14 Apr 2018
pdf
5 Product Grouping
( pdf, 784 KB )
(22357 downloads)
Popular
29 Nov 2021
pdf
6 DEF OF MD
( pdf, 444 KB )
(31598 downloads)
Popular
29 Nov 2021
pdf
6 DEF_OF_MD
( pdf, 442 KB )
(22249 downloads)
Popular
14 Apr 2018
pdf
7 EPSPMD
( pdf, 420 KB )
(19020 downloads)
Popular
14 Apr 2018
pdf
7 EPSPMD (1)
( pdf, 423 KB )
(25785 downloads)
Popular
29 Nov 2021
pdf
7 EPSPMD 1
( pdf, 470 KB )
(2674 downloads)
Popular
16 Nov 2021
«
1
2
3
4
…
9
10
»
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
×
