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(MD, NOT MD).pdf
( pdf, 143 KB )
(1154 muat turun)
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12 Jan 2025
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0 1 PDF BORANG PERMOHONAN JAWATAN KOSONG BK UKP 012 VER 1
( pdf, 115 KB )
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05 Okt 2022
pdf
1 CRU Flow Chart Process
( pdf, 96 KB )
(5980 muat turun)
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25 Mei 2022
pdf
1 Device Study Flow Chart Process
( pdf, 432 KB )
(5881 muat turun)
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25 Mei 2022
pdf
1- Fifth Edition Guideline for Medical Device- Drug and Drug-Medical Device Combination Product (Final) 21012025.pdf
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23 Jan 2025
pdf
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18 Okt 2024
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30 Jul 2024
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23 Jan 2025
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10(b) STATISTIK TAHUN 2024 UNIT KOMBINASI PRODUK.pdf
( pdf, 727 KB )
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23 Jan 2025
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10. Implementation requirement on quality management system (QMS) and traceability form.pdf
( pdf, 328 KB )
(3312 muat turun)
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13 Feb 2024
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10. Possible ways to register IVD analyzer.pdf
( pdf, 3.87 MB )
(2164 muat turun)
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13 Feb 2024
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10a. Mesyuarat Jawatankuasa Teknikal Pengkelasan dan Pendaftaran, JKTPP 2024 Schedule Planner.pdf
( pdf, 161 KB )
(1761 muat turun)
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13 Feb 2024
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11. MDA Approach on Expired EC Certificate for New Registration and Re-registration of Medical Device.pdf
( pdf, 147 KB )
(2481 muat turun)
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13 Feb 2024
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11. MEDICAL DEVICE RE-REGISTRATION APPLICATION - IMPLEMENTATION OF INITIAL MDA RESPONSE WITHIN 14 WORKING DAYS.pdf
( pdf, 31 KB )
(658 muat turun)
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13 Feb 2024
pdf
11. PENGUMUMAN TEMPOH PERALIHAN PELAKSANAAN PENGGUNAAN SIJIL PENDAFTARAN PERANTI PERUBATAN ELEKTRONIK v1.pdf
( pdf, 10 KB )
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13 Feb 2024
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12(a) ENDORSED 2023.pdf
( pdf, 195 KB )
(846 muat turun)
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23 Jan 2025
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12(b) ENDORSED 2024.pdf
( pdf, 122 KB )
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23 Jan 2025
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12a. How to check whether a device is registered or not.pdf
( pdf, 286 KB )
(5311 muat turun)
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13 Feb 2024
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13. Ringkasan Statistik Tahun 2023.pdf
( pdf, 87 KB )
(2656 muat turun)
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13 Feb 2024
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2 ESubmission New Notification (final)
( pdf, 196 KB )
(2350 muat turun)
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06 Jul 2022
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