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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DRAFT GUIDANCE DOCUMENTS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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Contoh Kategori Docman
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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pdf
Announcement for dispute
( pdf, 3.73 MB )
(619 downloads)
Popular
26 May 2025
document
Announcement GD Placement of HIVST in Malaysia market First Edition - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).docx
( docx, 10 KB )
(356 downloads)
Popular
25 Aug 2023
pdf
ANNOUNCEMENT UPDATE MDA APPROACH FOR NEW REGISTRATION OF MEDICAL DEVICES WITH EXPIRED EC CERTIFICATES
( pdf, 170 KB )
(1808 downloads)
Popular
05 Jun 2025
pdf
ANNOUNCEMENT UPDATE - MDA APPROACH FOR NEW AND RE-REGISTRATION OF MEDICAL DEVICES WITH EXPIRED EC CERTIFICATES AND SELF-DECLARED CLASS B IVD (Revision 22082024).pdf
( pdf, 147 KB )
(7585 downloads)
Popular
22 Aug 2024
document
Appendix 3 - Application form for endorsement letter of ancillary component for the registration of combination product – Appendix 3 (2).doc
( doc, 233 KB )
(2357 downloads)
Popular
22 Dec 2022
document
Appendix 4 - Application form for change variation of ancillary components for combination products – Appendix 4 (2).doc
( doc, 201 KB )
(1866 downloads)
Popular
22 Dec 2022
document
APPLICATION FORM FOR MD ADVERTISEMENT 2023.docx
( docx, 70 KB )
(3528 downloads)
Popular
09 Nov 2023
pdf
APPLICATION FORM FOR MD ADVERTISEMENT 2025.pdf
( pdf, 156 KB )
(980 downloads)
Popular
06 Feb 2025
document
Application form for medical device advertisement Jan 2022 (1)
( docx, 68 KB )
(3469 downloads)
Popular
23 Feb 2022
pdf
ARAHAN AM PELAKSANAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN MULAI 1 JULAI 2024 - MUHAMMAD FADZLI BIN RUSLI (MDA).pdf
( pdf, 332 KB )
(2554 downloads)
Popular
12 Aug 2024
pdf
Attachment 1 PC Draft GD Obsolete & Discontinued Medical Device.pdf
( pdf, 981 KB )
(2398 downloads)
Popular
13 Nov 2024
pdf
Attachment 18.pdf
( pdf, 109 KB )
(159 downloads)
Popular
22 Jan 2025
document
Attachment 2 PC Feedback Form OD Medical Devices.docx
( docx, 32 KB )
(700 downloads)
Popular
13 Nov 2024
pdf
ATTESTATION FORM 2025.pdf
( pdf, 91 KB )
(702 downloads)
Popular
19 Mar 2025
document
BK BDKS 054 Borang Ulasan Umum Pembangunan Garis Panduan
( docx, 28 KB )
(3006 downloads)
Popular
11 Feb 2022
document
BK BDKS 054 Borang Ulasan Umum Pembangunan Garis Panduan v2 8Feb2022
( docx, 28 KB )
(3128 downloads)
Popular
10 Feb 2022
document
Borang Conditional approval covid Form C
( docx, 79 KB )
(4596 downloads)
Popular
22 Nov 2021
pdf
BORANG PERMOHONAN PEGAWAI SAINS GRED C41 - Contract of Service.pdf
( pdf, 115 KB )
(1543 downloads)
Popular
06 Jul 2023
document
BORANG PERMOHONAN PEROLEHAN MDA - SEBUT HARGA, TENDER DAN RUNDINGAN TERUS.docx
( docx, 49 KB )
(221 downloads)
Popular
12 Feb 2025
document
BORANG ULASAN UMUM GD CFS, MC DAN CFS EO.docx
( docx, 29 KB )
(1425 downloads)
Popular
23 Dec 2022
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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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