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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DRAFT GUIDANCE DOCUMENTS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
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Forms
Events
Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
Product Classification
MDA Staff - Forms
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FCA
UKK
Strategic Plan
INFOGRAPHIC
Pelan Anti Rasuah
Buletin MDA
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
Pekeliling Kerajaan
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pdf
Surat Pekeliling MDA Bil. 1 (2024) BM.pdf
( pdf, 4.33 MB )
(5387 downloads)
Popular
06 May 2024
pdf
Surat Pekeliling MDA Bil. 1 (2024) EN.pdf
( pdf, 4.04 MB )
(6103 downloads)
Popular
06 May 2024
pdf
Surat Pekliling PBPP Bil 2 2014 (BM) Revision 4
( pdf, 304 KB )
(3184 downloads)
Popular
25 Oct 2021
pdf
Surat Pekliling PBPP Bil 2 2014 (Eng) Revision 4
( pdf, 292 KB )
(7069 downloads)
Popular
25 Oct 2021
pdf
Table MDDCI 2025
( pdf, 425 KB )
(3308 downloads)
Popular
21 Jul 2025
pdf
TABLE MDDCI 2025.pdf
( pdf, 311 KB )
(1138 downloads)
Popular
10 Feb 2025
pdf
Table of Fees.pdf
( pdf, 64 KB )
(5726 downloads)
Popular
21 Feb 2024
pdf
TATACARA PELAKSANAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN MULAI 1 JULAI 2024. (Kemaskini 9 Oktober 2024).pdf
( pdf, 319 KB )
(3493 downloads)
Popular
14 Oct 2024
pdf
TECHNICAL COMMITTEE MEETING MEDICAL DEVICE CLINICAL EVALUATION 2026
( pdf, 190 KB )
(1699 downloads)
Popular
24 Dec 2025
pdf
Teks Perutusan Khas YAB PM 10042020
( pdf, 482 KB )
(13313 downloads)
Popular
10 Apr 2020
pdf
Teks Perutusan YAB PM PENJANA 05062020
( pdf, 153 KB )
(4788 downloads)
Popular
09 Jun 2020
document
Template for list of Questions for Consultation with MDA
( docx, 26 KB )
(2926 downloads)
Popular
28 Apr 2022
document
Template for list of questions for consultation.docx
( docx, 103 KB )
(1370 downloads)
Popular
04 Apr 2023
document
TEMPLATE FOR LOA.docx
( docx, 41 KB )
(3239 downloads)
Popular
03 Mar 2025
document
TEMPLATE MEDICAL PRACTITIONER’S REQUEST LETTER (5)
( docx, 17 KB )
(462 downloads)
Popular
11 May 2026
pdf
The Training of Fundamental Understanding of Medical Devices & IVDs
( pdf, 4.28 MB )
(1254 downloads)
Popular
15 Jan 2026
pdf
Training 1 Training on Compliance with Licensing Requirements - TRAINING PACKAGE MDA (MDA).pdf
( pdf, 5.19 MB )
(1711 downloads)
Popular
27 Feb 2025
pdf
TRAINING 2 (1)
( pdf, 3.21 MB )
(696 downloads)
Popular
03 Mar 2026
pdf
TRAINING 3
( pdf, 1.87 MB )
(352 downloads)
Popular
23 Jan 2026
pdf
TRAINING 3 (1)
( pdf, 2.78 MB )
(594 downloads)
Popular
03 Mar 2026
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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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