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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DRAFT GUIDANCE DOCUMENTS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
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Awareness Program on Medical Device for Healthcare
Career
MeDC@St
Guideline Documents
GUIDANCE DOCUMENTS
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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UKK
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document
20100427 InfusionPump
( doc, 332 KB )
(3120 downloads)
Popular
04 Sep 2019
document
20100503 06 AN Tomotherapy
( doc, 320 KB )
(2978 downloads)
Popular
04 Sep 2019
document
20100510 07 A Mdtrnc
( doc, 320 KB )
(2975 downloads)
Popular
04 Sep 2019
document
20100609 07 A Mdtrnc Lifepak
( doc, 321 KB )
(2989 downloads)
Popular
04 Sep 2019
document
20100712 10 Alert VarianLINAC
( doc, 320 KB )
(3049 downloads)
Popular
05 Sep 2019
pdf
20100712 MDB Malaysia
( pdf, 257 KB )
(2891 downloads)
Popular
05 Sep 2019
pdf
20100712 RJ RRBC Information
( pdf, 221 KB )
(3150 downloads)
Popular
05 Sep 2019
document
20100719 11 CSL IVD
( doc, 324 KB )
(3023 downloads)
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05 Sep 2019
document
20100818 12 FSN Tomotherapy
( doc, 321 KB )
(3123 downloads)
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05 Sep 2019
document
20100907 13 FSN Thoratec
( doc, 320 KB )
(3125 downloads)
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05 Sep 2019
document
20101015 14 A Mdtrnc 5388
( doc, 321 KB )
(3090 downloads)
Popular
05 Sep 2019
document
20101112 16 AdvisoryNotice T Medic
( doc, 320 KB )
(3041 downloads)
Popular
05 Sep 2019
pdf
20101112 16 T Medic
( pdf, 81 KB )
(2886 downloads)
Popular
05 Sep 2019
document
2011 04 15 03A Mdtronic
( doc, 324 KB )
(3347 downloads)
Popular
05 Sep 2019
pdf
2011 04 15 2
( pdf, 1.15 MB )
(3508 downloads)
Popular
05 Sep 2019
document
2011 06 23 05A JnJ cypherselectstent
( doc, 323 KB )
(3047 downloads)
Popular
05 Sep 2019
pdf
2011 06 23 05A JnJ cypherselectstent2
( pdf, 129 KB )
(3031 downloads)
Popular
05 Sep 2019
document
2011 07 18 06A Fisher n Paykel CPAP Humid
( doc, 324 KB )
(3369 downloads)
Popular
05 Sep 2019
pdf
2021 06 A CPAP FSN Letter
( pdf, 159 KB )
(4980 downloads)
Popular
16 Jul 2021
pdf
2024 IGT BST 015 FSN D001915290 (MDA FCA P1318 19018758 2025) (hjOKpKck)
( pdf, 3.34 MB )
(1214 downloads)
Popular
26 Jun 2025
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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
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
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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