Pedoman Penilaian Alat Kesehatan dan Perbekalan Kesehatan ...

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Nomor: YF.05.03.V....................A D D E N D U M……..LAMPIRANKEPUTUSAN MENTERI KESEHATAN (disesuaikan dengan IPAK awal)REPUBLIK INDONESIANOMOR : .................................TANGGAL : .......................NAMA PERUSAHAAN : PT. ....................... ............ALAMAT : ......................................................................................MENYALURKAN ALAT KESEHATAN PRODUKSI DARI :NO. 1 S/D ...... SESUAI PADA LAMPIRAN TERDAHULU :.........PABRIK LUAR NEGERI........., ...........NEGARA..........Berlaku s/d ........................PERALATAN .................................- .......................................- .......................................Dengan ketentuan bahwa alat kesehatan tersebut harus mendapatkan persetujuan izin edar sebelumdiedarkan.JAKARTA, ............................................Direktur Jenderal............................................NIP. ..................................Hal 92
Lampiran 23. Template Certificate of Free Sale (CFS) untuk PKRTCERTIFICATE OF FREE SALENO. .....................................The undersigned hereby certifies that :a) The following products are manufactured in accor<strong>dan</strong>ce with the provisions ofthe law and regulations of the Republic of Indonesia.b) The manufacturing plant is subject to inspection at suitable intervals andconforms to the requirements for good practices in the manufacture and qualitycontrol.And that it has been officially registered and released for sale in the Republic ofIndonesia.• The Name of products, available package size and registration number asfollows :Product Name Package Size Registration Number• Manufactured by : .......................................• Address : .......................................• To be exported to : .......................................Jakarta, ....................................Director forMedical Devices Production and Distribution DevelopmentDirectorate General Pharmaceutical Servicesand Medical DevicesMinistry of Health of the Republic of Indonesia..................................................NIP. .........................................Hal 93
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BAB IPENDAHULUANA. Latar BelakangDa
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BAB IIPELAYANAN SERTIFIKAT PRODUKSI
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3. Salinan Sertifikat produksi lama
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BAB IIIPELAYANAN IZIN PENYALUR ALAT
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12. Penambahan jenis produk yang ak
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BAB IVPELAYANAN IZIN EDARA. Pelaksa
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B Pra-registrasiMerupakan proses pe
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Acuan/Matriks tersebut di atas adal
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Pabrik alat kesehatan perlu menginf
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Bagian ini menyatakan bagaimana per
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c. CFS berasal dari country of orig
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D. Izin Edar PKRTPERSYARATANData Ad
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− Untuk produk yang sama yang mem
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Keputusan PenilaianHasil penilaian
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Pembatalan Dan Pencabutan Persetuju
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BAB VPELAYANAN SURAT KETERANGANBeri
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BAB VIPENUTUPPedoman ini disusun de
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Lampiran 1. Formulir Pendaftaran Al
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LAMPIRAN BINFORMASI PRODUKNAMA PROD
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LAMPIRAN DPENANDAAN DAN PETUNJUK PE
Page 45 and 46: Lampiran 2. Formulir Pendaftaran Al
Page 47 and 48: LAMPIRAN BINFORMASI PRODUKNAMA PROD
Page 49 and 50: LAMPIRAN DPENANDAAN DAN PETUNJUK PE
Page 51 and 52: Lampiran 3. Form Pendaftaran Perbek
Page 53 and 54: LAMPIRAN BBSPESIFIKASI BAHAN BAKU D
Page 55 and 56: LAMPIRAN DDKEGUNAAN DAN CONTOHNAMA
Page 57 and 58: LAMPIRAN AAFORMULA/KOMPONEN & PROSE
Page 59 and 60: LAMPIRAN CCSPESIFIKASI DAN STABILIT
Page 61 and 62: Lampiran 5. Template Form Perubahan
Page 63 and 64: PemohonLampiran 6. Form Perpanjanga
Page 65 and 66: Lampiran 7. Template Izin Edar Baru
Page 67 and 68: Lampiran 9. Template Perubahan izin
Page 69 and 70: Lampiran 11. Template Perpanjangan
Page 71 and 72: Lampiran 13. Template Izin edar bar
Page 73 and 74: Lampiran 15. Template Perubahan izi
Page 75 and 76: Lampiran 17. Template Perpanjangan
Page 77 and 78: Lampiran 19. Template Sertifikat Pr
Page 79 and 80: KEPUTUSAN DIREKTUR JENDERAL BINA KE
Page 81 and 82: MEMUTUSKAN :MENETAPKAN :Pertama : M
Page 83 and 84: Template Perubahan Sertifikat Produ
Page 87 and 88: 12. Keputusan Menteri Kesehatan RI
Page 89 and 90: Template Perpanjangan Sertifikat Pr
Page 93 and 94: MEMUTUSKAN :MENETAPKAN :Pertama : M
Page 95: Lampiran 22. Template Addendum Izin
Page 99 and 100: Lampiran 24 Template Surat Keterang
Page 101 and 102: c) Bahan/produk tertentu yang berda
Page 103 and 104: Lampiran 25. Tambahan Data Sertifik
Page 105 and 106: Lampiran 27. Template Surat Keputus
Page 107 and 108: Lampiran 28. Form Permohonan Sertif
Page 109 and 110: DINAS KESEHATAN PROPINSILAPORANDATA
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