Jasa translate Free Sale Certificate di Bandung
- 28
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Undang-Undang Republik Indonesia Nomor 36 Tahun 2009 tentang Kesehatan Pasal 106 ayat (1) bahwa sediaan farmasi dan alat kesehatan hanya dapat diedarkan setelah mendapat izin edar. Pengaturan sediaan farmasi, alat kesehatan dan perbekalan kesehatan rumah tangga bertujuan untuk melindungi masyarakat dari resiko pengadaan, pembuatan dan peredaran sediaan farmasi, alat kesehatan dan perbekalan kesehatan rumah tangga yang tidak memenuhi standar dan persyaratan keamanan, khasiat/manfaat dan mutu serta melindungi masyarakat dari bahaya penyalahgunaan dan/atau penggunaan yang salah dari sediaan farmasi, alat kesehatan dan perbekalan kesehatan rumah tangga. Banyak produk sediaan farmasi, alat kesehatan dan perbekalan kesehatan rumah tangga yang beredar di masyarakat yang berasal dari negara lain tidak memiliki standar kesehatan sehingga berdampak buruk bagi kesehatan dan keamanan masyarakat. Hal tersebut perlu adanya pengamanan dan pengawasan oleh instansi terkait dalam regulasi sediaan farmasi, alat kesehatan dan perbekalan kesehatan rumah tangga baik dari dalam maupun dari luar negeri. Untuk mencegah masuknya produk ilegal/ tidak memenuhi peryaratan, salah satunya dibutuhkan surat keterangan dari Kementerian Kesehatan RI sebagai salah satu pengawasan produk sediaan farmasi, alat kesehatan dan perbekalan kesehatan rumah tangga yang dapat masuk ke wilayah Indonesia. Adalah surat keterangan yang dikeluarkan oleh Menteri yang menerangkan bahwa suatu produk alat kesehatan dan/atau PKRT sudah mendapatkan izin edar atau telah bebas dijual di Indonesia. Izin CFS atau Certificate of Free Sale dari adalah Izin yang digunakan untuk mendapat persetujuan edar dari pemerintah atas kegiatan usaha yang dilakukan.
Jenis Izin Certificate of Free Sale:
Izin Edar Alkes Elektromedik
Izin Edar Alkes Non Elektromedik
Izin Edar Alkes Diagnostik In Vitro
Izin Edar PKRT Luar Negeri dan Izin Edar PKRT Dalam Negeri
Persyaratan Izin Certificate of Free Sale:
Diterbitkan oleh pihak yang berwenang di negara asal
Menyatakan nama jenis pangan yang didaftarkan
Menyatakan nama dan alamat produsen di negara asal
Masa berlaku sesuai dengan yang tercantum pada sertifikat kesehatan/bebas jual beli.
Jika tidak tercantum pada surat penunjukan,maka masa berlaku paling lama 1 tahun sejak tanggal penerbitan. Certificate of Free Sale” (CFS) atau Sertifikat Bebas Jual adalah surat keterangan yang diterbitkan oleh instansi berwenang (seperti BPOM) yang menyatakan bahwa produk (misalnya kosmetik, alat kesehatan, atau obat-obatan) telah terdaftar dan diizinkan untuk diedarkan di wilayah Indonesia.
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