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pdf
ANNEX B.pdf
( pdf, 122 KB )
(7809 muat turun)
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21 Feb 2024
pdf
ANNEX C.pdf
( pdf, 52 KB )
(7335 muat turun)
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21 Feb 2024
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 )
(2927 muat turun)
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17 Mei 2024
pdf
Annoucement Update Recognition of the MDA as an Affiliate Member of the MDSAP and Utilization of MDSAP Reports and Certificates
( pdf, 128 KB )
(758 muat turun)
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25 Sep 2025
pdf
Annoucement Update Recognition of the MDA as an Affiliate Member of the MDSAP and Utilization of MDSAP Reports and Certificates
( pdf, 139 KB )
(1821 muat turun)
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01 Okt 2025
pdf
Announcement for dispute
( pdf, 3.73 MB )
(1639 muat turun)
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26 Mei 2025
pdf
ANNOUNCEMENT FOR IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE
( pdf, 91 KB )
(559 muat turun)
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14 Dis 2025
dokumen
Announcement GD Placement of HIVST in Malaysia market First Edition - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).docx
( docx, 10 KB )
(570 muat turun)
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25 Ogs 2023
pdf
ANNOUNCEMENT UPDATE MDA APPROACH FOR NEW REGISTRATION OF MEDICAL DEVICES WITH EXPIRED EC CERTIFICATES
( pdf, 170 KB )
(5179 muat turun)
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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 )
(8681 muat turun)
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22 Ogs 2024
dokumen
Appendix 3 - Application form for endorsement letter of ancillary component for the registration of combination product – Appendix 3 (2).doc
( doc, 233 KB )
(2684 muat turun)
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22 Dis 2022
dokumen
Appendix 4 - Application form for change variation of ancillary components for combination products – Appendix 4 (2).doc
( doc, 201 KB )
(2152 muat turun)
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22 Dis 2022
dokumen
APPLICATION FORM FOR MD ADVERTISEMENT 2023.docx
( docx, 70 KB )
(3846 muat turun)
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09 Nov 2023
pdf
APPLICATION FORM FOR MD ADVERTISEMENT 2025.pdf
( pdf, 156 KB )
(2237 muat turun)
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06 Feb 2025
dokumen
Application form for medical device advertisement Jan 2022 (1)
( docx, 68 KB )
(3901 muat turun)
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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 )
(3059 muat turun)
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12 Ogs 2024
pdf
ATTACHMENT 1 MAXIMUM QUANTITY ALLOWED FOR IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE
( pdf, 60 KB )
(656 muat turun)
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15 Dis 2025
pdf
Attachment 1 PC Draft GD Obsolete & Discontinued Medical Device.pdf
( pdf, 981 KB )
(4463 muat turun)
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13 Nov 2024
pdf
Attachment 11 Dialogue
( pdf, 168 KB )
(267 muat turun)
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11 Feb 2026
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Attachment 11 Training
( pdf, 132 KB )
(316 muat turun)
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11 Feb 2026
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