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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DRAFT GUIDANCE DOCUMENTS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
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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UKK
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- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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pdf
surat pekeliling bil.2_2018 (Eng)_Rev 2_Obsolete.pdf
( pdf, 1.25 MB )
(2897 downloads)
Popular
17 Mar 2023
pdf
surat pekeliling bil.2_2022_(eng).pdf
( pdf, 1.24 MB )
(2521 downloads)
Popular
04 Dec 2023
pdf
Surat Pekeliling MDA Bil. 1 (2024) BM.pdf
( pdf, 4.33 MB )
(4017 downloads)
Popular
06 May 2024
pdf
Surat Pekeliling MDA Bil. 1 (2024) EN.pdf
( pdf, 4.04 MB )
(4352 downloads)
Popular
06 May 2024
pdf
Surat Pekliling PBPP Bil 2 2014 (BM) Revision 4
( pdf, 304 KB )
(2648 downloads)
Popular
25 Oct 2021
pdf
Surat Pekliling PBPP Bil 2 2014 (Eng) Revision 4
( pdf, 292 KB )
(5822 downloads)
Popular
25 Oct 2021
pdf
SYARAT_SYARAT LESEN DUAL LANGUAGE_271222.pdf
( pdf, 57 KB )
(1796 downloads)
Popular
22 Jan 2024
pdf
TABLE MDDCI 2025.pdf
( pdf, 311 KB )
(613 downloads)
Popular
10 Feb 2025
pdf
Table of Fees.pdf
( pdf, 64 KB )
(3481 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 )
(1712 downloads)
Popular
14 Oct 2024
pdf
Teks Perutusan Khas YAB PM 10042020
( pdf, 482 KB )
(11998 downloads)
Popular
10 Apr 2020
pdf
Teks Perutusan YAB PM PENJANA 05062020
( pdf, 153 KB )
(3626 downloads)
Popular
09 Jun 2020
document
Template for list of Questions for Consultation with MDA
( docx, 26 KB )
(2434 downloads)
Popular
28 Apr 2022
document
Template for list of questions for consultation.docx
( docx, 103 KB )
(1008 downloads)
Popular
04 Apr 2023
document
TEMPLATE FOR LOA.docx
( docx, 41 KB )
(818 downloads)
Popular
03 Mar 2025
pdf
Training 1 Training on Compliance with Licensing Requirements - TRAINING PACKAGE MDA (MDA).pdf
( pdf, 5.19 MB )
(648 downloads)
Popular
27 Feb 2025
pdf
TRAINING 6 TRAINING ON MEDICAL DEVICE LABELLING AND ADVERTISEMENT REQUIREMENTS
( pdf, 1.31 MB )
(1734 downloads)
Popular
30 May 2025
pdf
TRAINING 7 TRAINING ON FUNDAMENTAL OF SOFTWARE AS MEDICAL DEVICE (SaMd)
( pdf, 1.07 MB )
(957 downloads)
Popular
10 Jun 2025
pdf
Training Calendar 2025 (Updated 13.5) - TRAINING PACKAGE MDA (MDA).pdf
( pdf, 828 KB )
(1940 downloads)
Popular
14 May 2025
document
UPDATED BORANG ULASAN UMUM PEMBANGUNAN DOKUMEN PANDUAN GD EXPORT ONLY.docx
( docx, 38 KB )
(333 downloads)
Popular
28 Apr 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
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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