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Project name
OEM Kasa
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Brand Brand OEM
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OEM - PT Kuningan Sarana Bersama
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Product
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gauze series
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NoCodeDoc NameDescriptionIssued & AuthorizedCheck List
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11Registration FormOEM Company
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2AAdministration Data
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3A1Production CertificateCPAKBFactory/PT KSB✓
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4A2Distribution Company LicenseIDAKOEM Company
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5A3-1Letter of Authorization (LoA)Surat Penunjukan DistributorFactory/PT KSB✓ DRAFT
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6A3-2Partnerships LetterPerjanjian Kerjasama OEMFactory/PT KSB & OEM Company✓ DRAFT
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7A4Letter of Appointment (LoA)Surat Penunjukan DistributorFactory/PT KSB✓ DRAFT
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8A5CPAKBFactory/PT KSB✓
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9ISO 13485ISO 13485Factory/PT KSB✓
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10CEFactory/PT KSBx
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11A6Executive Summary ProductRingkasan ProdukFactory/PT KSB✓
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12A7-1Attachment of Farmakope DocFactory/PT KSB✓
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13A7-2Declaration of Conformity (DOC)Deklarasi kesesuaian standardFactory/PT KSB✓
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14A8-1Agency Release LetterSurat pernyataan melepas keagenan/patent merekFactory/PT KSB & OEM Company
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15A8-2Brand Patent HAKI for OEM ProductBrand OEMMerek HAKI
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16A9Letter of Authenticity of DocsPernyataan keaslian dokumenOEM Company
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17A10Integrity PactPakta IntegritasOEM Company
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18BProduct Information
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19B11Raw Material of GauzeFactory/PT KSB✓
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20B13Production ProcessProduction Flow ChartFactory/PT KSB✓
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21C
Specification and Quality Assurance
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22C1
Characteristics and technical spec product
Karakter dan Spesifikasi ProdukFactory/PT KSB✓
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23C3
Summary of verification and docs validation
Sertifikasi ISO 13845 dengan pihak ke 3
Sucofindo✓
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24C8Risk analysis of product
Sertifikasi ISO 13845 dengan pihak ke 3
Sucofindo
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25C10
Specification or raw material requirement
Factory/PT KSB✓
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26C13-1Lab TestReport Analysis hasil LabSucofindo✓
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27C13-2Certificate of Analysis (COA)COAFactory/PT KSB✓
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28C13-3QC Pass/Inspection ReportTest ReportFactory/PT KSB✓
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29DLabelling
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30D1Example of Labeling
Contoh kemasan dan keterangan label
Drafter(OEM/Factory)
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31D2Existing Marking on the ApplianceKeterangan simbol pada kemasanDrafter(OEM/Factory)
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32D3-1User Manual (bahasa)Factory/PT KSB✓
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33D3-2User Manual (english)Factory/PT KSB✓
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34D4Production Code and MeaningFactory/PT KSB✓
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35D5List of Accessories/Code/Type/SizeExcel AksesoriesOEM Company
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36D6Supporting data of AccessoriesFile pendukung aksesorisFactory/PT KSB
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37EPost Market Evaluation
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38E1Handing Complaints ProceduresSOP Penanganan KomplainOEM Company
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398PaymentBukti pembayaran PNBPOEM Company
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