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December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data
Dikunjungi: 5407
December 2021 : Initial Reporting FA 21072 : Field Safety Notification on AU/DxC AU Magnesium - IFU update due to lipemic interference for the Magnesium serum application failed to meet the performance specification.
Dikunjungi: 8056
November 2021 : Customer Safety Information (CSI) for Field Safety Corrective Action FCA AX077/21/S | FSN AX078/21/S, AX081/21/S : ComboBox does no longer login automatically after several reboots. Calculation of Cardiac Output (Thermodilution method) on
Dikunjungi: 7740
November 2021 : FSN-2021-013 DR0155M Thermo Scientific™ Campylobacter Test Kit: Auto-agglutinating in all the test latexes with + to ++ reactions.
Dikunjungi: 12880
November 2021 : FCA Notification - iDesign Advanced Wavescan Studio System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Dikunjungi: 9689
November 2021 : FCA Notification - CATALYS™ Precision Laser System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Dikunjungi: 13337
November 2021 : Initial Report for CR-2021-IGT-BST-011 (FCO72200484) - Leakage of cooling fluid of flat detector in the R-cabinet ®
Dikunjungi: 13180
November 2021 : FA1197 Abre Venous Self-expanding Stent System IFU Update
Dikunjungi: 5582
November 2021 : FSCA Notifications - 006 ASW 22-01 Atellica CH 930 Analyzer : Issues with setting Open Channel Assay parameters.
Dikunjungi: 4900
November 2021 : Field Corrective Action Report GLB143074 - Freelite® Human Lambda Free Kit (for use on the SPAPLUS®) : Imprecision at top of calibration curve
Dikunjungi: 14030
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Utama
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Carta Organisasi
Kod Etika dan Tatakelakuan
Lembaga Pengarah
Pengurusan Tertinggi MDA
Kepimpinan Malaysia
Mantan CEO MDA
Bahagian
Pejabat Ketua Eksekutif
Unit Integriti
Unit Audit Dalam
Bahagian Hubungan Antarabangsa dan Industri
Bahagian Kawalan Pra Pasaran
Bahagian Dasar dan Perancangan Strategik
Bahagian Pasca Pasaran
Bahagian Penguatkuasaan
Bahagian Khidmat Pengurusan
Bahagian Kewangan
bahagian Komunikasi Korporat
Bahagian Undang-undang
Bahagian Digital dan Teknologi Maklumat
Bahagian Keurusetiaan
Unit Transformasi Regulatori
Soalan Lazim
Pelaksanaan Polisi Satu Lesen Tunggal
Pendaftaran, Pelesenan & Penguatkuasaan
Pelabelan Peranti Perubatan
Penilaian Teknikal
Hubungi
Borang Aduan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Surat Pekeliling
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Standard
Arahan AM
Pelan Strategik
Persembahan Slide
Infografik
Pelan Antirasuah Organisasi (OACP)
Buletin MDA
Siaran Akhbar
Liputan Media (Keratan Akhbar)
Laporan Tahunan
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