Our Hotline+603 - 8230 0300

fas fa-search
Loading...

Folder UKK

Documents

Toggle Title Date
pdf ANNEX B.pdf ( pdf, 122 KB ) (7829 downloads) Popular
pdf ANNEX C.pdf ( pdf, 52 KB ) (7355 downloads) Popular
pdf ANNOUCEMENT - ESTABLISHMENTS ARE ADVISED TO SUBMIT MEDICAL DEVICE RE-REGISTRATION APPLICATION IN THE MeDC@St2.0+ SYSTEM ONE YEAR PRIOR TO CERTIFICATE EXPIRY DATE.pdf ( pdf, 65 KB ) (2949 downloads) Popular
pdf Annoucement Update Recognition of the MDA as an Affiliate Member of the MDSAP and Utilization of MDSAP Reports and Certificates ( pdf, 128 KB ) (772 downloads) Popular
pdf Annoucement Update Recognition of the MDA as an Affiliate Member of the MDSAP and Utilization of MDSAP Reports and Certificates ( pdf, 139 KB ) (1865 downloads) Popular
pdf Announcement for dispute ( pdf, 3.73 MB ) (1665 downloads) Popular
pdf ANNOUNCEMENT FOR IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE ( pdf, 91 KB ) (585 downloads) Popular
document Announcement GD Placement of HIVST in Malaysia market First Edition - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).docx ( docx, 10 KB ) (583 downloads) Popular
pdf ANNOUNCEMENT UPDATE MDA APPROACH FOR NEW REGISTRATION OF MEDICAL DEVICES WITH EXPIRED EC CERTIFICATES ( pdf, 170 KB ) (5236 downloads) Popular
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 ) (8704 downloads) Popular
document Appendix 3 - Application form for endorsement letter of ancillary component for the registration of combination product – Appendix 3 (2).doc ( doc, 233 KB ) (2698 downloads) Popular
document Appendix 4 - Application form for change variation of ancillary components for combination products – Appendix 4 (2).doc ( doc, 201 KB ) (2165 downloads) Popular
document APPLICATION FORM FOR MD ADVERTISEMENT 2023.docx ( docx, 70 KB ) (3861 downloads) Popular
pdf APPLICATION FORM FOR MD ADVERTISEMENT 2025.pdf ( pdf, 156 KB ) (2256 downloads) Popular
document Application form for medical device advertisement Jan 2022 (1) ( docx, 68 KB ) (3920 downloads) Popular
pdf ARAHAN AM PELAKSANAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN MULAI 1 JULAI 2024 - MUHAMMAD FADZLI BIN RUSLI (MDA).pdf ( pdf, 332 KB ) (3078 downloads) Popular
pdf ATTACHMENT 1 MAXIMUM QUANTITY ALLOWED FOR IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE ( pdf, 60 KB ) (685 downloads) Popular
pdf Attachment 1 PC Draft GD Obsolete & Discontinued Medical Device.pdf ( pdf, 981 KB ) (4501 downloads) Popular
pdf Attachment 11 Dialogue ( pdf, 168 KB ) (281 downloads) Popular
pdf Attachment 11 Training ( pdf, 132 KB ) (339 downloads) Popular

Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

+603 - 8230 0300

SPLASK Multilang Active
Accessibility Tag Active
Dasar Privasi
Medical Device Act 2012 (English) Lawatan Regulatori ke UAE - Mei 2025 Maklumat CIO KKM HRMIS MeDC@St 2.0

Today 15201 Yesterday 17327 Week 109969 Month 78587 Visitor Counter: 134537978

  • Last Updated: 03 April 2026.

Copyright © 2023 - 2025 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768
Maximize
Chat Now