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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DRAFT GUIDANCE DOCUMENTS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
CAB & Establishment
Regulation
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Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
Product Classification
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UKK
Strategic Plan
INFOGRAPHIC
Pelan Anti Rasuah
Buletin MDA
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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pdf
OPTIMA XR240AMX.pdf
( pdf, 547 KB )
(1715 downloads)
Popular
14 Jan 2025
pdf
OUS_outside of EMEA_FSN 2024-HHE-022B Final (MDA_Recall_P0385_64232512_2025) (S6XtGuep).pdf
( pdf, 411 KB )
(1438 downloads)
Popular
05 May 2025
pdf
P.U. (A) 78_2024 - Perintah Peranti Perubatan (Pengecualian) 2024.pdf
( pdf, 450 KB )
(14617 downloads)
Popular
07 Mar 2024
pdf
Pekeliling Bil 2 2016 (BM) Rev 2
( pdf, 296 KB )
(1885 downloads)
Popular
21 Jun 2022
pdf
PHC25-01.A.OUS Customer Letter (MDA_FCA_P1186_26399040_2025) (MUZp8eAY).pdf
( pdf, 234 KB )
(2150 downloads)
Popular
03 Mar 2025
pdf
PHILIPS VUE PACS.pdf
( pdf, 468 KB )
(1821 downloads)
Popular
17 Dec 2024
pdf
PK INSTRUMENTS.pdf
( pdf, 835 KB )
(2353 downloads)
Popular
05 Feb 2024
Image
POSTER CHATBOT.jpg
( jpg, 1.14 MB )
(5580 downloads)
Popular
17 Aug 2024
pdf
Power Express Centrifuge.pdf
( pdf, 375 KB )
(2361 downloads)
Popular
02 Sep 2024
pdf
Press Release MDA SIN
( pdf, 123 KB )
(283 downloads)
Popular
12 Mar 2026
document
Product Classification Application Form 2023 2.0.docx
( docx, 77 KB )
(2543 downloads)
Popular
05 Mar 2024
pdf
PROTEUS XR.pdf
( pdf, 344 KB )
(2172 downloads)
Popular
02 Sep 2024
pdf
R2008 001
( pdf, 101 KB )
(4914 downloads)
Popular
28 Aug 2019
pdf
R2008 002
( pdf, 59 KB )
(4877 downloads)
Popular
28 Aug 2019
pdf
R2008 003
( pdf, 330 KB )
(4807 downloads)
Popular
28 Aug 2019
pdf
R2008 004
( pdf, 64 KB )
(4402 downloads)
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28 Aug 2019
pdf
R2008 005
( pdf, 56 KB )
(4664 downloads)
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28 Aug 2019
pdf
R2008 006
( pdf, 335 KB )
(5328 downloads)
Popular
28 Aug 2019
pdf
R2008 007
( pdf, 362 KB )
(4548 downloads)
Popular
28 Aug 2019
pdf
R2008 008
( pdf, 77 KB )
(4547 downloads)
Popular
28 Aug 2019
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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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