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Home Public Information
Work Unit: Directorate General of Pharmaceuticals and Medical Devices
PPID superior: Secretary General
| No | Type of Information | Official/Work Unit who controls the information | Time and Location of Information Generation |
|---|---|---|---|
| 1 | Pharmaceutical Profile of Directorate General of Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | Annually, Jakarta |
| 2 | List of Pharmacies throughout Indonesia | Secretariat of the Directorate General | Annually, Jakarta |
| 3 | List of drugstore facilities throughout Indonesia | Secretariat of the Directorate General | Annually, Jakarta |
| 4 | List of Cosmetics Industry Facilities throughout Indonesia | Secretariat of the Directorate General | Annually, Jakarta |
| 5 | List of Traditional Medicine Industry Facilities throughout Indonesia | Secretariat of the Directorate General | Annually, Jakarta |
| 6 | List of Traditional Medicine Small/Micro Business Facilities throughout Indonesia | Secretariat of the Directorate General | Annually, Jakarta |
| 7 | List of Pharmaceutical Industry Facilities throughout Indonesia | Secretariat of the Directorate General | Annually, Jakarta |
| 8 | List of Pharmaceutical Wholesaler Facilities throughout Indonesia | Secretariat of the Directorate General | Annually, Jakarta |
| 9 | List of Medical Device Distribution Facilities throughout Indonesia | Secretariat of the Directorate General | Annually, Jakarta |
| 10 | List of Medical Device Industries | Secretariat of the Directorate General | Annually, Jakarta |
| 11 | List of Household Health Supplies Industry Facilities | Secretariat of the Directorate General | Annually, Jakarta |
| 12 | Performance Report (LKj) of DG Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | Annually, Jakarta |
| 13 | Performance Report (LKj) of the Secretariat of the Directorate General of Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | Annually, Jakarta |
| 14 | RKAKL / DIPA Ditjen Farmalkes | Secretariat of the Directorate General | Annually, Jakarta |
| 15 | Program Action Plan (RAP) Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | Annually, Jakarta |
| 16 | Activity Action Plan (RAK) of Secretariate of the Directorate General of Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | Annually, Jakarta |
| 17 | RKAKL / DIPA Ditjen Farmalkes | Secretariat of the Directorate General | Annually, Jakarta |
| 18 | Legislation and Regulations in the Field of Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | Annually, Jakarta |
| 19 | Infarkes Bulletin | Secretariat of the Directorate General | 2023, Jakarta |
| 20 | List of Decree on Credit Score Assessment of Functional Position of Pharmacist and Pharmacist Assistant | Secretariat of the Directorate General | Annually, Jakarta |
| 21 | Recapitulation of Incoming Letters and Outgoing Letters | Secretariat of the Directorate General | Annually, Jakarta |
| 22 | Recapitulation of Procurement of Goods and Services of the Secretariat of the Directorate General of Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | Annually, Jakarta |
| 23 | Financial Statement of Directorate General of Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | 2022, Jakarta |
| 24 | Financial Statement of the Secretariat of the Directorate General of Pharmaceuticals and Medical Devices | Secretariat of the Directorate General | 2022, Jakarta |
| 25 | Public Complaint Reports | Secretariat of the Directorate General | 2023, Jakarta |
| 26 | Clinical Data Interpretation Guidelines | Directorate of Pharmaceutical Management and Services | 2011, Jakarta |
| 27 | Pharmaceutical Services Guidelines for Antibiotics | Directorate of Pharmaceutical Management and Services | 2011, Jakarta |
| 28 | Visite Guidelines | Directorate of Pharmaceutical Management and Services | 2011, Jakarta |
| 29 | Technical Guidelines for Evaluation of Drug Utilization in Health Facilities | Directorate of Pharmaceutical Management and Services | 2015, Jakarta |
| 30 | Minister of Health Regulation Number 53 of 2016 concerning Revocation of Minister of Health Regulation Number 284/MENKES/PER/III/2007 concerning Community Pharmacies | Directorate of Pharmaceutical Management and Services | 2016, Jakarta |
| 31 | Circular Letter of the Minister of Health Number HK.03.03/MENKES/704/2016 on the Implementation of the Minister of Health Regulation Number 53/2016 on the Revocation of the Minister of Health Regulation Number 284/MENKES/PER/III/2007 on Community Pharmacies | Directorate of Pharmaceutical Management and Services | 2016, Jakarta |
| 32 | Minister of Health Regulation Number 72 of 2016 concerning Pharmaceutical Service Standards in Hospitals | Directorate of Pharmaceutical Management and Services | 2016, Jakarta |
| 33 | Minister of Health Regulation Number 73 of 2016 concerning Pharmaceutical Service Standards at Pharmacies | Directorate of Pharmaceutical Management and Services | 2016, Jakarta |
| 34 | Minister of Health Regulation Number 74 of 2016 concerning Pharmaceutical Service Standards at Health Centers | Directorate of Pharmaceutical Management and Services | 2016, Jakarta |
| 35 | Minister of Health Regulation Number 9 of 2017 concerning Pharmacies | Directorate of Pharmaceutical Management and Services | 2017, Jakarta |
| 36 | Training Module on Pharmaceutical Services for Pharmacists at Puskesmas | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 37 | Technical Guidelines for Pharmaceutical Service Standards in Hospitals | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 38 | Technical Guidelines for Pharmaceutical Service Standards at Puskesmas | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 39 | Technical Guidelines for Pharmaceutical Service Standards in Pharmacies | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 40 | Guidelines for Pharmaceutical Services in Diabetes Mellitus | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 41 | Guidelines for Pharmaceutical Services in Hypertension | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 42 | Training Curriculum for Pharmaceutical Services for Pharmaceutical Workers at Puskesmas | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 43 | SE. Number HK.02.01/MENKES/283/2019 concerning Placement of Pharmacists at Puskesmas | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 44 | Minister of Health Regulation Number 28 of 2022 concerning Changes in the Classification, Restrictions and Categories of Medicines | Directorate of Pharmaceutical Management and Services | 2022, Jakarta |
| 45 | IEC material GeMa CerMat 2020 - 2022 | Directorate of Pharmaceutical Management and Services | 2022, Jakarta |
| 46 | GeMa CerMat 2023 IEC material | Directorate of Pharmaceutical Management and Services | 2023, Jakarta |
| 47 | National Formulary (Kepmenkes No. HK.01.07/MENKES/2197/2023) | Directorate of Pharmaceutical Management and Services | 2023, Jakarta |
| 48 | Formulary of Drugs and Health Supplies for Hajj Health Services (Kepmenkes No. HK.01.07/MENKES/69/2020) | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 49 | Guidelines for the Formulation and Implementation of the National Formulary (Permenkes No. 54/2018) | Directorate of Pharmaceutical Management and Services | 2018, Jakarta |
| 50 | Report on the availability of drugs and vaccines at health centers and in regencies/cities | Directorate of Pharmaceutical Management and Services | Annually, Jakarta |
| 51 | Report on the implementation of the drug and BMHP logistics monitoring system in Provinces/ Regencies/Cities | Directorate of Pharmaceutical Management and Services | Annually, Jakarta |
| 52 | E-monev application for drug catalog | Directorate of Pharmaceutical Management and Services | Annually, Jakarta |
| 53 | Training materials for pharmaceutical management in Regency/City Pharmacy Installations | Directorate of Pharmaceutical Management and Services | 2010, Jakarta |
| 54 | List of SOPs of the Directorate of Public Medicine and Health Supplies Management | Directorate of Pharmaceutical Management and Services | Annually, Jakarta |
| 55 | Recapitulation of procurement of goods and services Directorate of Pharmaceutical Management and Services | Directorate of Pharmaceutical Management and Services | Annually, Jakarta |
| 56 | Position map of the Directorate of Public Medicine and Health Supplies Management | Directorate of Pharmaceutical Management and Services | 2022, Jakarta |
| 57 | Performance report of the Directorate of Pharmaceutical Management and Services | Directorate of Pharmaceutical Management and Services | Annually, Jakarta |
| 58 | Handbook • Calculation matrix of drug and vaccine needs of the program • RPJMN and Strategic Plan 2020-2024 Indicators | Directorate of Pharmaceutical Management and Services | 2020, Jakarta |
| 59 | Decree of the Minister of Health Number HK.01.07/MENKES/381/2020 on the Value of Drug Price Claims for the Reverse Referral Program, Chronic Disease Drugs at Advanced Referral Health Facilities and Chemotherapy Drugs | Directorate of Pharmaceutical Management and Services | Annually, Jakarta |
| 60 | Minister of Health Regulation Number 5 of 2019 concerning Planning and Procurement of Medicines Based on Electronic Catalog | Directorate of Pharmaceutical Management and Services | 2019, Jakarta |
| 61 | Permenkes No. 17 Tahun 2017 tentang Rencana Aksi Pengembangan Industri Farmasi dan Alat Kesehatan | Directorate of Pharmaceutical Production and Distribution | 2017, Jakarta |
| 62 | Daftar Industri Farmasi yang memiliki Izin Importir Produsen Narkotika, Psikotropika dan Prekursor Farmasi | Directorate of Pharmaceutical Production and Distribution | Anytime, Jakarta |
| 63 | Daftar Pedagang Besar Farmasi yang memiliki Izin Importir Terdaftar Psikotropika dan Prekursor Farmasi | Directorate of Pharmaceutical Production and Distribution | Anytime, Jakarta |
| 64 | Daftar Industri Farmasi yang memiliki Izin Eksportir Produsen Narkotika, Psikotropika dan Prekursor Farmasi | Directorate of Pharmaceutical Production and Distribution | Anytime, Jakarta |
| 65 | Daftar Industri Farmasi yang diterbitkan izin usahanya | Directorate of Pharmaceutical Production and Distribution | Anytime, Jakarta |
| 66 | Daftar Pedagang Besar Farmasi yang diterbitkan izin usahanya | Directorate of Pharmaceutical Production and Distribution | Anytime, Jakarta |
| 67 | Indonesian Pharmacopoeia VI Edition | Directorate of Pharmaceutical Production and Distribution | 2020, Jakarta |
| 68 | Peraturan Menteri Kesehatan Nomor 1799/Menkes/Per/XII/2010 tentang Industri Farmasi | Directorate of Pharmaceutical Production and Distribution | 2010, Jakarta |
| 69 | Peraturan Menteri Kesehatan Nomor 16 Tahun 2013 tentang Perubahan atas Peraturan Menteri Kesehatan Nomor 1799/Menkes/Per/XII/2010 tentang Industri Farmasi | Directorate of Pharmaceutical Production and Distribution | 2013, Jakarta |
| 70 | Peraturan Menteri Kesehatan Nomor 1148/Menkes/Per/VI/2011 tentang Pedagang Besar Farmasi | Directorate of Pharmaceutical Production and Distribution | 2011, Jakarta |
| 71 | Peraturan Menteri Kesehatan Nomor 34 Tahun 2014 tentang Perubahan atas Peraturan Menteri Kesehatan Nomor 1148/Menkes/Per/VI/2011 tentang Pedagang Besar Farmasi | Directorate of Pharmaceutical Production and Distribution | 2014, Jakarta |
| 72 | Minister of Health Regulation Number 30 of 2017 concerning the Second Amendment to Minister of Health Regulation Number 1148/Menkes/Per/VI/2011 concerning Pharmaceutical Wholesalers | Directorate of Pharmaceutical Production and Distribution | 2017, Jakarta |
| 73 | Minister of Health Regulation Number 4 of 2023 concerning the Implementation of Plasma Fractionation | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 74 | Kodeks Makanan Indonesia 2018 | Directorate of Pharmaceutical Production and Distribution | 2019, Jakarta |
| 75 | Supplements to the Indonesian Food Codex | Directorate of Pharmaceutical Production and Distribution | 2022, Jakarta |
| 76 | Second Indonesian Food Codex Supplement | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 77 | e-KMI (Kodeks Makanan Indonesia) | Directorate of Pharmaceutical Production and Distribution | 2019, Jakarta |
| 78 | Minister of Health Regulation Number 033 of 2012 on Food Additives | Directorate of Pharmaceutical Production and Distribution | 2012, Jakarta |
| 79 | Modul TOT Penyuluh Keamanan Pangan (PKP) Industri Rumah Tangga Pangan (IRTP) bagi Tenaga Kesehatan di Wilayah Kerjanya | Directorate of Pharmaceutical Production and Distribution | 2019, Jakarta |
| 80 | Modul Pelatihan Penyuluh Keamanan Pangan (PKP) Industri Rumah Tangga Pangan (IRTP) bagi Tenaga Kesehatan di Wilayah Kerjanya | Directorate of Pharmaceutical Production and Distribution | 2019, Jakarta |
| 81 | Daftar Nota Kesepahaman Bersama (MoU) Fasilitasi Peralatan Pusat Pengolahan Pasca Panen Tanaman Obat (P4TO) | Directorate of Pharmaceutical Production and Distribution | Annually |
| 82 | Daftar Perjanjian Kerja Sama (PKS) Pelaksanaan Fasilitasi Peralatan Pusat Pengolahan Pasca Panen Tanaman Obat | Directorate of Pharmaceutical Production and Distribution | Annually |
| 83 | Daftar Perjanjian Kerja Sama (PKS) Fasilitasi Peralatan Laboratorium Pada Pusat Pengolahan Pasca Panen Tanaman Obat | Directorate of Pharmaceutical Production and Distribution | Annually |
| 84 | Indonesian Herbal Pharmacopoeia Second Edition | Directorate of Pharmaceutical Production and Distribution | 2017, Jakarta |
| 85 | Buku Acuan Bahan Baku Obat Tradisional dari Tumbuhan Obat di Indonesia | Directorate of Pharmaceutical Production and Distribution | 2017, Jakarta |
| 86 | Minister of Health Regulation Number 006 of 2012 concerning the Traditional Medicine Industry and Business | Directorate of Pharmaceutical Production and Distribution | 2012, Jakarta |
| 87 | Minister of Health Regulation Number 007 of 2012 on Traditional Medicine Registration | Directorate of Pharmaceutical Production and Distribution | 2012, Jakarta |
| 88 | Minister of Health Regulation Number 1175/MENKES/PER/VIII/2010 on Cosmetics Production License | Directorate of Pharmaceutical Production and Distribution | 2010, Jakarta |
| 89 | Minister of Health Regulation Number 63 of 2013 on the Amendment of Minister of Health Regulation Number 1175/MENKES/PER/VIII/2010 on Cosmetics Production License | Directorate of Pharmaceutical Production and Distribution | 2013, Jakarta |
| 90 | Materia Kosmetika Bahan Alam Indonesia | Directorate of Pharmaceutical Production and Distribution | 2015, Jakarta |
| 91 | Buku Saku Memilih Kosmetika yang Baik | Directorate of Pharmaceutical Production and Distribution | 2020, Jakarta |
| 92 | Kodeks Kosmetika Indonesia Edisi II Volume 3 | Directorate of Pharmaceutical Production and Distribution | 2012, Jakarta |
| 93 | Kodeks Kosmetika Indonesia Edisi II Volume 4 | Directorate of Pharmaceutical Production and Distribution | 2014, Jakarta |
| 94 | Phytopharmaceutical Formulary | Directorate of Pharmaceutical Production and Distribution | 2022, Jakarta |
| 95 | Supplement I Indonesian Herbal Pharmacopoeia II Edition | Directorate of Pharmaceutical Production and Distribution | 2022, Jakarta |
| 96 | Materia Cosmetica Indonesian Natural Ingredients Essential Oil Series | Directorate of Pharmaceutical Production and Distribution | 2022, Jakarta |
| 97 | Laporan Kinerja (LAKIP) Direktorat Produksi dan Distribusi Kefarmasian | Directorate of Pharmaceutical Production and Distribution | Annually, Jakarta |
| 98 | Daftar SOP Direktorat Produksi dan Distribusi Kefarmasian | Directorate of Pharmaceutical Production and Distribution | Annually, Jakarta |
| 99 | Daftar SK Direktorat Produksi dan Distribusi Kefarmasian | Directorate of Pharmaceutical Production and Distribution | Annually, Jakarta |
| 100 | Recapitulation of Incoming Letters and Outgoing Letters | Directorate of Pharmaceutical Production and Distribution | Annually, Jakarta |
| 101 | Rekapitulasi Pengadaan Barang dan Jasa | Direktorat Produksi Kefarmasian Direktorat Produksi dan Distribusi Kefarmasian | Annually, Jakarta |
| 102 | Laporan Keuangan Direktorat Produksi Kefarmasian (yg sudah diaudit) | Directorate of Pharmaceutical Production and Distribution | Annually, Jakarta |
| 103 | Farmakope Indonesia Edisi VI Suplemen I | Directorate of Pharmaceutical Production and Distribution | 2022, Jakarta |
| 104 | Petunjuk Teknis Mutu Kendali Obat | Directorate of Pharmaceutical Production and Distribution | 2020, Jakarta |
| 105 | Farmakope Indonesia Edisi VI Suplemen II | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 106 | Kepmenkes Nomor HK.01.07/MENKES/1276/2023 tentang Nilai Klaim Harga Obat Rujuk Balik, Obat Penyakit Kronis di FKRTL, Obat Kemoterapi, dan Obat Alteplase | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 107 | Kepmenkes Nomor HK. 01.07/MENKES/1333/2023 tentang Peningkatan Penggunaan Sediaan Farmasi yang Menggunakan Bahan Baku Produksi Dalam Negeri | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 108 | Kepmenkes Nomor HK.01.07/MENKES/1314/2023 tentang Substitusi Obat dan Alat Kesehatan Impor Dengan Obat dan Alat Kesehatan Dalam Negeri Pada Katalog Elektronik Sektoral Kesehatan | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 109 | Permenkes Nomor 5 Tahun 2023 tentang Narkotika, Psikotropika, dan Prekursor Farmasi | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 110 | Permenkes Nomor 29 Tahun 2023 tentang Perubahan Penggolongan Prekursor | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 111 | Permenkes Nomor 30 Tahun 2023 tentang Perubahan Penggolongan Narkotika | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 112 | Permenkes Nomor 31 Tahun 2023 tentang Penetapan dan Perubahan Penggolongan Psikotropika | Directorate of Pharmaceutical Production and Distribution | 2023, Jakarta |
| 113 | Peraturan Menteri Kesehatan Republik Indonesia Nomor 7 Tahun 2020 tentang Perubahan atas Peraturan Menteri Kesehatan Nomor 51 Tahun 2014 tentang Pemasukan Alat Kesehatan Melalui Mekanisme Jalur Khusus (Special Access Scheme) | Directorate of Medical Devices Production and Distribution | 2020, Jakarta (Revision in progress) |
| 114 | Peraturan Menteri Kesehatan Republik Indonesia Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan, Alat kesehatan IVD dan PKRT | Directorate of Medical Devices Production and Distribution | 2017, Jakarta (revision in progress) |
| 115 | Minister of Health Regulation Number 63 of 2017 concerning Good Clinical Testing Methods for Medical Devices | Directorate of Medical Devices Production and Distribution | 2017, Jakarta (Dithan) |
| 116 | Minister of Health Regulation Number 17 of 2017 concerning Action Plan for the Development of the Pharmaceutical and Medical Device Industry | Directorate of Medical Devices Production and Distribution | 2017, Jakarta |
| 117 | Peraturan Menteri Kesehatan Republik Indonesia Nomor 76 Tahun 2013 Tentang Iklan Alat Kesehatan Dan Perbekalan Kesehatan Rumah Tangga | Directorate of Medical Devices Production and Distribution | 2013, Jakarta |
| 118 | Panduan Komunikasi, Informasi dan Edukasi Cerdas Meggunakan Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga | Directorate of Medical Devices Production and Distribution | 2020, Jakarta |
| 119 | Guidelines for Evalution of Medical Devices and In Vitro Diagnostic Medical Devices According to the Regulation of the Minister of Health of the Republic of Indonesia Number 62 of 2017 | Directorate of Medical Devices Production and Distribution | 2020, Jakarta |
| 120 | In Vitro Diagnostic Medical Devices and Medical Devices Grouping Guidelines | Directorate of Medical Devices Production and Distribution | 2019, Jakarta |
| 121 | Pedoman Penilaian Izin Edar Alat Kesehatan Sesuai Dengan Permenkes Nomor 62 Tahun 2017 | Directorate of Medical Devices Production and Distribution | 2019, Jakarta |
| 122 | Technical Guidance Guidelines for Licensing of Household Health Supplies | Directorate of Medical Devices Production and Distribution | 2018, Jakarta |
| 123 | Guidelines on the Procedure for Granting Approval for Advertisement of Medical Devices, In Vitro Diagnostic Devices and PKRT | Directorate of Medical Devices Production and Distribution | 2018, Jakarta |
| 124 | Katalog alkes dalam negeri | Directorate of Medical Devices Production and Distribution | 2018, Jakarta |
| 125 | Peraturan Menteri Kesehatan Republik Indonesia Nomor 60 Tahun 2017 tentang Tata Niaga Impor Alkes, Alkes IVD, dan Perbekkes | Directorate of Medical Devices Production and Distribution | 2017, Jakarta |
| 126 | Peraturan Menteri Kesehatan Republik Indonesia Nomor 14 Tahun 2021 Tentang Standar kegiatan usaha dan produk pada penyelenggaraan perizinan berusaha dan berbasis resiko sektor kesehatan | Directorate of Medical Devices Production and Distribution | 2021, Jakarta |
| 127 | Keputusan Menteri Kesehatan Republik Indonesia No. HK.01.07/ Menkes/ 161/ 2023 tentang Penggunaan tes cepat dalam pemeriksaan COVID-19 | Directorate of Medical Devices Production and Distribution | 2023, Jakarta |
| 128 | Kepdirjen Farmalkes Tentang Pelaksanaan Uji Klinik Alkes Prapemasaran dan Pascapemasaran | Direktorat Ketahanan Kefarmasian dan Alkes | 2023, Jakarta |
| 129 | KMK No. HK.01.07/MENKES/1333/2023 tentang Peningkatan Penggunaan Sediaan Farmasi yang Menggunakan Bahan Baku Dalam Negeri | Direktorat Ketahanan Kefarmasian dan Alkes | 2023, Jakarta |
| 130 | KMK No. HK.01.07/MENKES/1314/2023 tentang Substitusi Obat dan Alat Kesehatan Impor pada Katalog Elektronik Sektoral Kesehatan | Direktorat Ketahanan Kefarmasian dan Alkes | 2023, Jakarta |
| 131 | Petunjuk Teknis Pelaksanaan Sampling dan Pengujian Alkes dan PKRT | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 132 | Pedoman Pengawasan Iklan Alkes dan PKRT | Direktorat Pengawasan Alkes | 2017, Jakarta |
| 133 | Kurikulum Pelatihan Pengawasan Produk Alat Kesehatan dan PKRT | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 134 | Modul Pelatihan Pengawasan Produk Alat Kesehatan dan PKRT | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 135 | Tata Cara Penarikan dan Pemusnahan Alat Kesehatan dan PKRT | Direktorat Pengawasan Alkes | 2020, Jakarta |
| 136 | Petunjuk Teknis Investigasi KTD Alat Kesehatan | Direktorat Pengawasan Alkes | 2020, Jakarta |
| 137 | Daftar Sampel Produk Alat Kesehatan dan PKRT yang Diuji | Direktorat Pengawasan Alkes | Annually |
| 138 | Daftar Produk Alat Kesehatan dan PKRT yang Diawasi Penandaannya | Direktorat Pengawasan Alkes | Annually |
| 139 | Daftar Iklan Alat Kesehatan dan PKRT yang diawasi | Direktorat Pengawasan Alkes | Annually |
| 140 | Petunjuk Teknis Pengawasan Sarana Penyalur Alkes | Direktorat Pengawasan Alkes | 2017, Jakarta |
| 141 | Petunjuk Teknis Pengawasan Sarana Produksi Alkes dan PKRT | Direktorat Pengawasan Alkes | 2019, Jakarta |
| 142 | Petunjuk Teknis Fasilitasi Penerapan Sistem Pengawasan Alat Kesehatan dan PKRT Secara On Line | Direktorat Pengawasan Alkes | 2017, Jakarta |
| 143 | Permenkes Nomor 60 Tahun 2017 tentang Pengawasan Tata Niaga Impor Alkes dan PKRT di Luar Kawasan Kepabeanan (Post Border) | Direktorat Pengawasan Alkes | 2017, Jakarta |
| 144 | Kepmenkes nomor HK.01.07/Menkes/234/2018 tentang Daftar Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga Impor Yang Pengawasannya Dilakukan Dalam Kawasan Pabean (Border) dan Diluar Kawasan Pabean (Post Border) | Direktorat Pengawasan Alkes | 2018, Jakarta |
| 145 | Kurikulum Pelatihan Pengawasan Sarana Produksi dan Distribusi Alat Kesehatan dan PKRT | Direktorat Pengawasan Alkes | 2018, Jakarta |
| 146 | Modul Pelatihan Pengawasan Sarana Produksi dan Distribusi Alat Kesehatan dan PKRT | Direktorat Pengawasan Alkes | 2018, Jakarta |
| 147 | Panduan Teknis Pengawasan Alat Kesehatan Non Elektromedik Steril dan Alkes Diagnostik In Vitro di Sarana Distribusi Alat Kesehatan | Direktorat Pengawasan Alkes | 2019, Jakarta |
| 148 | Panduan Teknis Pengawasan Alat Kesehatan Non Elektromedik Steril dan Alkes Diagnostik In Vitro di Sarana Produksi Alat Kesehatan | Direktorat Pengawasan Alkes | 2019, Jakarta |
| 149 | Kurikulum Pelatihan Pengawasan Alat Kesehatan Non Elektromedik Steril dan Alkes Diagnostik In Vitro di Sarana Produksi dan Distribusi Alat Kesehatan | Direktorat Pengawasan Alkes | 2019, Jakarta |
| 150 | Modul Pelatihan Pengawasan Alat Kesehatan Non Elektromedik Steril dan Alkes Diagnostik In Vitro di Sarana Produksi dan Distribusi Alat Kesehatan | Direktorat Pengawasan Alkes | 2019, Jakarta |
| 151 | Petunjuk Teknis Pengawasan Alat Kesehatan Elektromedik Radiasi dan Non Radiasi di Sarana Distribusi Alat Kesehatan | Direktorat Pengawasan Alkes | 2019, Jakarta |
| 152 | Petunjuk Teknis Pengawasan Alat Kesehatan dan PKRT di Post Border | Direktorat Pengawasan Alkes | 2020, Jakarta |
| 153 | Daftar Standar Nasional Indonesia Alat Kesehatan dan PKRT | Direktorat Pengawasan Alkes | Annually |
| 154 | Laporan Kinerja Direktorat Pengawasan Alkes | Direktorat Pengawasan Alkes | Annually |
| 155 | Daftar SOP Direktorat Pengawasan Alkes | Direktorat Pengawasan Alkes | Annually |
| 156 | Daftar SK Direktorat Pengawasan Alkes | Direktorat Pengawasan Alkes | Annually |
| 157 | Recapitulation of Incoming Letters and Outgoing Letters | Direktorat Pengawasan Alkes | Annually |
| 158 | Peta jabatan dan analisis beban kerja Direktorat Pengawasan Alat Kesehatan dan PKRT | Direktorat Pengawasan Alkes | Annually |
| 159 | Laporan Keuangan dan BMN Direktorat Pengawasan Alat Kesehatan dan PKRT | Direktorat Pengawasan Alkes | Annually |
| 160 | Daftar Sertifikat CPAKB/CPPKRTB | Direktorat Pengawasan Alkes | Annually |
| 161 | Daftar Sertifikat CDAKB | Direktorat Pengawasan Alkes | Annually |
| 162 | Penyelenggaraan Penguatan Laboratorium Pengujian Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga | Direktorat Pengawasan Alkes | 2022, Jakarta |
| 163 | Petunjuk Teknis Pengawasan Toko Alat Kesehatan dan Optikal | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 164 | Procedure for Reporting Adverse Events (AEs) of Medical Devices | Direktorat Pengawasan Alkes | 2020, Jakarta |
| 165 | Pedoman Standar Pelayanan Publik Sertifikasi Cara Pembuatan Alat Kesehatan yang Baik (CPAKB) dan Cara Pembuatan Perbekalan Kesehatan yang Baik (CPPKRTB) | Direktorat Pengawasan Alkes | 2022, Jakarta |
| 166 | Keputusan Menteri Kesehatan Nomor HK.01.07/MENKES/477/2021 Tentang Laboratorium Penguji Validitas Rapid Diagnostic Test Antigen (RDT-Ag) | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 167 | Keputusan Menteri Kesehatan Nomor HK.01.07/Menkes/1337/2022 Tentang Pedoman Penyelenggaraan Perusahaan Rumah Tangga Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga | Direktorat Pengawasan Alkes | 2022, Jakarta |
| 168 | Petunjuk Operasional Penerapan CPAKB | Direktorat Pengawasan Alkes | 2018, Jakarta |
| 169 | Petunjuk Operasional Penerapan CPPKRTB | Direktorat Pengawasan Alkes | 2018, Jakarta |
| 170 | Modul CDAKB | Direktorat Pengawasan Alkes | 2018, Jakarta |
| 171 | Kepdirjen HK.02.02/I/1174/2021 tentang Kurikulum dan Modul Pelatihan Cara Distribusi Alat Kesehatan yang Baik | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 172 | Kepdirjen HK.02.02/I/1175/2021 tentang Pelatihan CPAKB dan CPPKRTB | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 173 | Kepdirjen HK.02.02/I/1177/2021 tentang Kurikulum dan Modul Pelatihan Pengelolaan Toko Alkes yang Baik | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 174 | Kepdirjen HK.02.01/I/1176/2021 tentang Kurikulum dan Modul Penyuluhan Rumah Tangga Alkes dan PKRT | Direktorat Pengawasan Alkes | 2021, Jakarta |
| 175 | Surat Edaran Dirjen Farmalkes tentang Daftar Jejaring Laboratorium Pengujian Alkes dan PKRT | Direktorat Pengawasan Alkes | 2023, Jakarta |
| 176 | Surat Edaran CPAKB sebagai persyaratan izin edar | Direktorat Pengawasan Alkes | 2023, Jakarta |
| 177 | Surat Edaran Pengujian Post Market Alkes | Direktorat Pengawasan Alkes | 2023, Jakarta |
| 178 | Standar Pengujian Post-Market Produk Rapid Diagnostic Test (Antibodi HIV, Antibodi Sifilis, Antigen Covid-19, Antigen Denque NS-1, Antigen Hepatitis B, dan Antigen Malaria) | Direktorat Pengawasan Alkes | 2022, Jakarta |
| 179 | Permenkes Nomor 4 Tahun 2014 tentang CDAKB | Direktorat Pengawasan Alkes | 2014, Jakarta |
Directorate General of Pharmaceutical
and Medical Devices
Ministry of Health of The Republic of Indonesia
Dr. Adhyatma, MPH Building, 8th Floor R.817
Jalan H.R. Rasuna Said Blok X-5 Kav. 4-9
South Jakarta 12950
Hello Kemkes ✆ 1500567
