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pdf ANNEX B.pdf ( pdf, 122 KB ) (6836 downloads) Popular
pdf ANNEX C.pdf ( pdf, 52 KB ) (6532 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 ) (2489 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 ) (486 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 ) (644 downloads) Popular
pdf Announcement for dispute ( pdf, 3.73 MB ) (1190 downloads) Popular
document Announcement GD Placement of HIVST in Malaysia market First Edition - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).docx ( docx, 10 KB ) (458 downloads) Popular
pdf ANNOUNCEMENT UPDATE MDA APPROACH FOR NEW REGISTRATION OF MEDICAL DEVICES WITH EXPIRED EC CERTIFICATES ( pdf, 170 KB ) (3719 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 ) (8240 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 ) (2542 downloads) Popular
document Appendix 4 - Application form for change variation of ancillary components for combination products – Appendix 4 (2).doc ( doc, 201 KB ) (2011 downloads) Popular
document APPLICATION FORM FOR MD ADVERTISEMENT 2023.docx ( docx, 70 KB ) (3679 downloads) Popular
pdf APPLICATION FORM FOR MD ADVERTISEMENT 2025.pdf ( pdf, 156 KB ) (1688 downloads) Popular
document Application form for medical device advertisement Jan 2022 (1) ( docx, 68 KB ) (3702 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 ) (2820 downloads) Popular
pdf Attachment 1 PC Draft GD Obsolete & Discontinued Medical Device.pdf ( pdf, 981 KB ) (3503 downloads) Popular
pdf Attachment 12 23 SEPTEMBER 2025 ( pdf, 342 KB ) (488 downloads) Popular
pdf Attachment 18.pdf ( pdf, 109 KB ) (279 downloads) Popular
document Attachment 2 PC Feedback Form OD Medical Devices.docx ( docx, 32 KB ) (1122 downloads) Popular
pdf ATTESTATION FORM 2025.pdf ( pdf, 91 KB ) (1307 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

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Medical Device Act 2012 (English) Lawatan Regulatori ke UAE - Mei 2025 Maklumat CIO KKM HRMIS MeDC@St 2.0

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  • Last Updated: 09 December 2025.

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