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Penyusunan pedoman bertujuan menyamakan pemahaman agar persyaratan keamanan, mutu, dan manfaat terpenuhi sebelum produk beredar di Indonesia. Perizinan izin edar diberikan setelah pemenuhan persyaratan administrasi dan teknis oleh Tim Penilai melalui tata cara serta kebutuhan pengajuan yang ditetapkan dalam regulasi.",{"@graph":51,"@context":100},[52,68,83],{"@type":53,"itemListElement":54},"BreadcrumbList",[55,59,62,65],{"item":56,"name":57,"@type":58,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":60,"name":10,"@type":58,"position":61},"https://docshare.wps.com/id/template/",2,{"item":63,"name":35,"@type":58,"position":64},"https://docshare.wps.com/id/template/surat/",3,{"item":66,"name":47,"@type":58,"position":67},"https://docshare.wps.com/id/template/guidelines-for-evaluation-of-medical-devices-in-accordance-with-minister-of-health-regulation-no-62-of-2017/234469/",4,{"url":66,"name":47,"@type":69,"author":70,"headline":47,"publisher":73,"fileFormat":76,"inLanguage":45,"description":49,"dateModified":77,"datePublished":77,"encodingFormat":76,"isAccessibleForFree":78,"interactionStatistic":79},"DigitalDocument",{"name":71,"@type":72},"Bill Black","Person",{"url":56,"name":74,"@type":75},"DocShare","Organization","application/pdf","2026-09-11",true,{"@type":80,"interactionType":81,"userInteractionCount":4},"InteractionCounter",{"@type":82},"ViewAction",{"@type":84,"mainEntity":85},"FAQPage",[86,92,96],{"name":87,"@type":88,"acceptedAnswer":89},"Apa dasar hukum pedoman penilaian alat kesehatan ini?","Question",{"text":90,"@type":91},"Pedoman ini disusun sesuai Permenkes Republik Indonesia No. 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro, dan Perbekalan Kesehatan Rumah Tangga.","Answer",{"name":93,"@type":88,"acceptedAnswer":94},"Kapan izin edar alat kesehatan dapat diperoleh?",{"text":95,"@type":91},"Izin edar diperoleh setelah produk dinyatakan memenuhi persyaratan administrasi dan teknis oleh Tim Penilai.",{"name":97,"@type":88,"acceptedAnswer":98},"Apa tujuan pedoman bagi Tim Penilai?",{"text":99,"@type":91},"Pedoman ini digunakan sebagai acuan untuk melakukan evaluasi dan verifikasi alat kesehatan serta diagnostik in vitro, termasuk tata cara dan persyaratan pengajuan agar sesuai regulasi.","https://schema.org",{"og:url":66,"og:type":102,"og:title":47,"og:site_name":74,"og:description":49},"article",{"robots":104,"canonical":66},"index,follow",{"doc_id":106,"site_id":44},234469,1789087482,{"code":4,"msg":5,"data":109},{"doc_id":106,"user_id":110,"nickname":71,"user_avatar":111,"doc_module":9,"category_id":34,"category_name":35,"doc_title":47,"doc_description":49,"doc_content":112,"file_id":113,"file_url":114,"file_type":115,"file_size":116,"view_count":4,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":117,"language":118,"language_code":45,"site_id":44,"html_lang":45,"table_of_contents":119,"faqs":120,"seo_title":121,"seo_description":49,"update_tm":107,"read_time":122},24189269381491,"https://ap-avatar.wpscdn.com/avatar/160000cf11732dd8392?x-image-process=image/resize,m_fixed,w_180,h_180&k=1788146458752108895","GUIDELINES FOR EVALUATION   \nOF MEDICAL DEVICES AND IN VITRO  \nDIAGNOSTIC MEDICAL DEVICES  \nACCORDING TO THE REGULATION OF THE MINISTER OF HEALTH    \nOF THE REPUBLIC OF INDONESIA NUMBER 62 OF 2017  \nISBN 978-623-301-025-2  \nKATA SAMBUTAN  \nDIREKTUR JENDERAL KEFARMASIAN DANALAT KESEHATAN KEMENTERIAN KESEHATAN  \nPuji Syukur kami panjatkan kepada Tuhan Yang Maha Esakarena atas karunia- Nya sehingga Pedoman Penilaian Alat Kesehatan ini dapat diselesaikan.  \nSesuai dengan amanat Peraturan Menteri Kesehatan No.  \n62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga, bahwa persyaratan keamanan, mutu dan manfaat Alat Kesehatanharus dipenuhi sebelum beredar di Indonesia.  \nIzinedarAlat Kesehatan diperoleh setelah dinyatakan memenuhipersyaratan administrasi dan teknis oleh Tim Penilai. Oleh karenaitu dibutuhkan pemahaman yang sama dalam melakukan penilaian dan evaluasi terhadap Alat Kesehatan. Berdasarkan hal tersebut, Direktorat Penilaian Alat Kesehatan dan PKRT menyusun Pedoman PenilaianAlat KesehatanSesuaidengan Permenkes Nomor 62 Tahun 2017 ini sebagai acuan bagi Tim Penilai untuk melakukan evaluasi dan verifikasi alat kesehatan dan alat kesehatan diagnostik in vitro terkait tata cara dan persyaratan permohonan untuk mendapatkan persetujuan izin edar.  \nKami mengucapkan terima kasih kepada semua pihak yang telah berkontribusi terhadap tersusunnya buku Pedoman ini. Semoga Pedoman ini dapat memberikan kemanfaatan yang besar bagi Tim Penilai dalam melakukan bimbingan teknis perizinanAlat Kesehatan.  \nJakarta, November 2020  \nDirektur Jenderal Kefarmasian dan Alat Kesehatan Kementerian Kesehatan RI  \nttd  \nDra. Engko Sosialine Magdalene, Apt., M.Bio Med  \nNIP. 196101191988032001  \nREMARK  \nDIRECTOR GENERAL OF PHARMACEUTICALAND MEDICAL DEVICE MINISTRY OF HEALTH  \nPraise and gratitude, we pray to God Almighty for the gift of His so this Guidelines for Evaluation of Medical Devices can be completed.  \nIn accordance with the mandate of the Regulation of the Minister of Health Number. 62 of 2017 concerning Product License of Medical Devices, In Vitro Diagnostic Medical Devices and Household Health Products, that the requirements of safety, quality and efficacy/ performance of Medical Devices must be fulfilled before distributed in Indonesia.  \nProduct license of medical devices are issued after stated that it meets the administrative and technical requirements by the Evaluation Team. Therefore, the same understanding is needed in conducting the assessment and evaluation of Medical Devices. Based on this, the Directorate of Medical Device and Household Health Product Evaluation develop Guidelines for Evaluation of Medical Devices in accordance with the Regulation of the Minister of Health Number 62 of 2017 as a reference for the Evaluation Team to conduct evaluation and verification of Medical Devices and In Vitro Diagnostic Medical Devices related to procedures and application requirements to obtain product license approval.  \nWe thank all those who have contributed to the development of this Guideline. Hopefully this Guideline can provide great benefits for the Evaluation Team in conducting technical guidance for Medical Devices licensing.  \nJakarta, November 2020  \nDirector General of Pharmaceutical and Medical Device Ministry of Health Republic of Indonesia  \nsigned  \nDra. Engko Sosialine Magdalene, Apt., M.Bio Med  \nNIP. 196101191988032001  \nKATA PENGANTAR  \nDIREKTUR PENILAIAN ALAT KESEHATAN DAN PERBEKALAN KESEHATAN RUMAH TANGGA  \nDiawali puji syukur kita panjatkan ke hadirat Tuhan Yang Maha Esa karena atas karunia-Nya, buku Pedoman Penilaian Alat Kesehatan Sesuai dengan Permenkes Nomor 62 Tahun 2017 inidapat diselesaikan dengan baik.  \nBerdasarkan Permenkes No. 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga, maka produkalat kesehatanyang beredardi Indonesia harus memiliki izin edar. Pengajuan pend","cbCaiiJNkRiocABH","https://ap.wps.com/l/cbCaiiJNkRiocABH","pdf",5990158,226,"Indonesian","# Kata Sambutan\n## Arahan Direktur Jenderal Kefarmasian dan Alat Kesehatan\n# Kata Pengantar\n## Arahan Direktur Penilaian Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga","[{\"question\":\"Apa dasar hukum pedoman penilaian alat kesehatan ini?\",\"answer\":\"Pedoman ini disusun sesuai Permenkes Republik Indonesia No. 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro, dan Perbekalan Kesehatan Rumah Tangga.\"},{\"question\":\"Kapan izin edar alat kesehatan dapat diperoleh?\",\"answer\":\"Izin edar diperoleh setelah produk dinyatakan memenuhi persyaratan administrasi dan teknis oleh Tim Penilai.\"},{\"question\":\"Apa tujuan pedoman bagi Tim Penilai?\",\"answer\":\"Pedoman ini digunakan sebagai acuan untuk melakukan evaluasi dan verifikasi alat kesehatan serta diagnostik in vitro, termasuk tata cara dan persyaratan pengajuan agar sesuai regulasi.\"}]","Pedoman Penilaian Alat Kesehatan - Sesuai Permenkes Nomor 62 Tahun 2017 | PDF",79]