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Minister of Health Regulation No. 14 of 2021 on Standards for Business Activities and Products in Risk-Based Licensing in the Health Sector
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Minister of Health Regulation No. 14 of 2021 establishes standards for business activities and products within the framework of risk-based licensing in the health sector. This regulation is particularly relevant for businesses operating in healthcare, including hospitals, clinics, and pharmaceutical companies. It outlines the necessary requirements and procedures that these entities must follow to obtain the appropriate licenses for their operations. Key obligations include compliance with health and safety standards, ensuring that products meet quality requirements, and maintaining proper documentation for licensing purposes. The regulation interacts with other related regulations, such as those governing the One Stop Service (OSS) system and the Business Identification Number (NIB), which are essential for the overall licensing process. By adhering to these standards, businesses can facilitate smoother operations and ensure compliance with national health regulations, ultimately contributing to a safer healthcare environment in Indonesia.
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BERITA NEGARA REPUBLIK INDONESIA No.316, 2021 KEMENKES. Kegiatan Usaha dan Produk. Perizinan Berusaha. Standar. Pencabutan. PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA NOMOR 14 TAHUN 2021 TENTANG STANDAR KEGIATAN USAHA DAN PRODUK PADA PENYELENGGARAAN PERIZINAN BERUSAHA BERBASIS RISIKO SEKTOR KESEHATAN DENGAN RAHMAT TUHAN YANG MAHA ESA MENTERI KESEHATAN REPUBLIK INDONESIA, Menimbang : bahwa untuk melaksanakan ketentuan Pasal 6 ayat (7) Peraturan Pemerintah Nomor 5 Tahun 2021 tentang Penyelenggaraan Perizinan Berusaha Berbasis Risiko dan Pasal 5 ayat (3) Peraturan Pemerintah Nomor 47 Tahun 2021 tentang Penyelenggaraan Bidang Perumahsakitan, perlu menetapkan Peraturan Menteri Kesehatan tentang Standar Kegiatan Usaha dan Produk pada Penyelenggaraan Perizinan Berusaha Berbasis Risiko Sektor Kesehatan; Mengingat : 1. Pasal 17 ayat (3) Undang-Undang Dasar Negara Republik Indonesia Tahun 1945; 2. Undang-Undang Nomor 39 Tahun 2008 tentang Kementerian Negara (Lembaran Negara Republik Indonesia Tahun 2008 Nomor 166, Tambahan Lembaran Negara Republik Indonesia Nomor 4916); 3. Undang-Undang Nomor 36 Tahun 2009 tentang Kesehatan (Lembaran Negara Republik Indonesia Tahun www.peraturan.go.id -- 1 of 1832 -- 2021, No.316 -2- 2009 Nomor 144, Tambahan Lembaran Negara Republik Indonesia Nomor 5063); 4. Undang-Undang Nomor 11 Tahun 2020 tentang Cipta Kerja (Lembaran Negara Republik Indonesia Tahun 2020 Nomor 245, Tambahan Lembaran Negara Republik Indonesia Nomor 6573); 5. Peraturan Pemerintah Nomor 5 Tahun 2021 tentang Penyelenggaraan Perizinan Berusaha Berbasis Risiko (Lembaran Negara Republik Indonesia Tahun 2021 Nomor 15, Tambahan Lembaran Negara Republik Indonesia Nomor 6617); 6. Peraturan Presiden Nomor 18 Tahun 2021 tentang Kementerian Kesehatan (Lembaran Negara Republik Indonesia Tahun 2021 Nomor 83); 7. Peraturan Menteri Kesehatan Nomor 25 Tahun 2020 tentang Organisasi dan Tata Kerja Kementerian Kesehatan (Berita Negara Republik Indonesia Tahun 2020 Nomor 1146); MEMUTUSKAN: Menetapkan : PERATURAN MENTERI KESEHATAN TENTANG STANDAR KEGIATAN USAHA DAN PRODUK PADA PENYELENGGARAAN PERIZINAN BERUSAHA BERBASIS RISIKO SEKTOR KESEHATAN. Pasal 1 Menetapkan standar kegiatan usaha dan produk pada penyelenggaraan perizinan Berusaha Berbasis Risiko sektor kesehatan tercantum dalam Lampiran yang merupakan bagian tidak terpisahkan dari Peraturan Menteri ini. Pasal 2 Perizinan Berusaha Berbasis Risiko sektor kesehatan sebagaimana dimaksud dalam Pasal 1 dilaksanakan melalui Sistem Perizinan Berusaha Terintegrasi Secara Elektronik. www.peraturan.go.id -- 2 of 1832 -- 2021, No.316 Pasal 3 Pada saat Peraturan Menteri ini mulai berlaku, Peraturan Menteri yang mengatur mengenai standar kegiatan usaha dan standar produk dalam Penyelenggaran Perizinan Berusaha sektor kesehatan dinyatakan masih tetap berlaku sepanjang tidak bertentangan dengan Peraturan Menteri ini. Pasal 4 Sistem Perizinan Berusaha Terintegrasi Secara Elektronik sebagaimana dimaksud dalam Pasal 2 mulai dilaksanakan sejak proses perizinan berusaha dilakukan secara keseluruhan berdasarkan Peraturan Pemerintah Nomor 5 Tahun 2021 tentang Penyelenggaraan Perizinan Berusaha Berbasis Risiko. Pasal 5 Pada saat Peraturan Menteri ini mulai berlaku, Peraturan Menteri Kesehatan Nomor 24 Tahun 2016 tentang Persyaratan Teknis Bangunan dan Prasarana Rumah Sakit (Berita Negara Republik Indonesia Tahun 2016 Nomor 1197), dicabut dan dinyatakan tidak berlaku. Pasal 6 Peraturan Menteri ini mulai berlaku pada tanggal diundangkan. www.peraturan.go.id -- 3 of 1832 -- 2021, No.316 -4- Agar setiap orang mengetahuinya, memerintahkan pengundangan Peraturan Menteri ini dengan penempatannya dalam Berita Negara Republik Indonesia. Ditetapkan di Jakarta pada tanggal 1 April 2021 MENTERI KESEHATAN REPUBLIK INDONESIA, ttd. BUDI G. SADIKIN Diundangkan di Jakarta pada tanggal 1 April 2021 DIREKTUR JENDERAL PERATURAN PERUNDANG-UNDANGAN KEMENTERIAN HUKUM DAN HAK ASASI MANUSIA REPUBLIK INDONESIA, ttd. 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Untuk pekerjaan kepatuhan dan dispute, rujuk teks asli Bahasa Indonesia.
Peraturan Menteri Kesehatan Nomor 14 Tahun 2021 tentang Standar Kegiatan Usaha dan Produk pada Penyelenggaraan Perizinan Berusaha Berbasis Risiko Sektor Kesehatan
tentang KESEHATAN - PERIZINAN, PELAYANAN PUBLIK - CIPTA KERJA
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