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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DRAFT GUIDANCE DOCUMENTS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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- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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pdf
AHWP REGISTRATION FORM
( pdf, 1.62 MB )
(3897 downloads)
Popular
03 Sep 2018
pdf
ANNOUNCEMENT VOLUNTARY LISTING OF TECHNICAL PERSONNEL, TRAINING BODY OR COMPETENCY CERTIFICATION BOD
( pdf, 153 KB )
(6196 downloads)
Popular
27 Jan 2018
document
Appendix A new website
( docx, 16 KB )
(5224 downloads)
Popular
16 Jul 2019
document
Application Form 100420
( docx, 15 KB )
(6006 downloads)
Popular
10 Apr 2020
pdf
APPLICATION FORM Contract Manufacturer
( pdf, 345 KB )
(3836 downloads)
Popular
26 Jul 2018
document
Application Form for Biomedical Technical Personnel
( docx, 139 KB )
(3982 downloads)
Popular
26 Jan 2018
document
Application Form for Medical Device Competency Certification Body
( doc, 112 KB )
(5283 downloads)
Popular
26 Jan 2018
document
Application Form for Medical Device Training Body
( docx, 22 KB )
(3476 downloads)
Popular
26 Jan 2018
document
Applicationform4meddeviceads officialver0 (1)
( docx, 41 KB )
(4361 downloads)
Popular
27 Jul 2021
pdf
BD-BDKS-045_V1
( pdf, 59 KB )
(3221 downloads)
Popular
22 Feb 2018
pdf
BKBDKS054 Borang Ulasan Umum Pembangunan Garis Panduan PG
( pdf, 52 KB )
(3266 downloads)
Popular
13 Mar 2020
pdf
BKBDKS054 Borang Ulasan Umum Pembangunan GP IVD Rule
( pdf, 52 KB )
(2937 downloads)
Popular
13 Mar 2020
pdf
Borang Conditional approval covid Form C
( pdf, 149 KB )
(7138 downloads)
Popular
09 Mar 2022
pdf
BORANG PERMOHONAN BADAN PENILAIAN PEMATUHAN (CAB) VERSI 02
( pdf, 236 KB )
(3696 downloads)
Popular
04 Sep 2018
pdf
BORANG PERMOHONAN PERTAMBAHAN KAKITANGAN TEKNIKAL 24012018
( pdf, 317 KB )
(5111 downloads)
Popular
25 Jan 2018
pdf
BORANG PERMOHONAN PERTAMBAHAN KAKITANGAN TEKNIKAL 31072018
( pdf, 640 KB )
(3912 downloads)
Popular
04 Sep 2018
document
BTP Training Tentative Jun 2020
( docx, 74 KB )
(2926 downloads)
Popular
17 Jun 2020
document
Ci 1. Notification to Import Or Supply Medical Devices For Clinical Investigational Use
( doc, 518 KB )
(3738 downloads)
Popular
01 Mar 2018
document
Ci 2. Notification To Import Medical Devices For Clinical Use And Research Suportive Use
( doc, 487 KB )
(3879 downloads)
Popular
01 Mar 2018
document
CI 3. Serious Adverse Events (SAE)
( doc, 366 KB )
(3277 downloads)
Popular
01 Mar 2018
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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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