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5a. GMD Risk Classification.pdf
( pdf, 253 KB )
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13 Feb 2024
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5APPEN_1.DOC
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23 Jan 2025
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5b. IVD Risk Classification.pdf
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13 Feb 2024
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6 Clinical Investigational Plan (CIP)
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25 Mei 2022
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6a. Grouping GMD.pdf
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13 Feb 2024
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6b. Grouping - IVD.pdf
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7 Clinical Performance Study Protocol (CPSP)
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06 Jul 2022
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7 Investigator's Brochure (IB)
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25 Mei 2022
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7. Conformity Assessment for Medical Device.pdf
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13 Feb 2024
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7. Conformity Assessment for Medical Device.pdf
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05 Nov 2024
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7. Process Flow for Approval Letter for Changes to Ancillary Medical Device Component Application.pdf
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8 Investigator's Brochure (IB)
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06 Jul 2022
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8. Recognized foreign regulatory authorities and notified bodies and the respective approval types eligible for conformity assessment by way of verification process.pdf
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13 Feb 2024
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9.Fee Structure MDR.pdf
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13 Feb 2024
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AKAUNTAN GRED WA41.pdf
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AKAUNTAN GRED WA41.pdf
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21 Feb 2024
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21 Feb 2024
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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
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17 Mei 2024
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Utama
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Bahagian
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Bahagian Pendaftaran, Pelesenan Dan Penguatkuasaan
Post Market & Enforcement Division
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International and Industry Affairs Division
Unit Pengurusan Dan Perkhidmatan
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Single License Policy Implementation
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Labelling of Medical Devices
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