Setiap manusia memiliki hak yang sama dalam memperoleh akses atas sumber daya di bidang kesehatan serta pelayanan kesehatan yang aman, bermutu, dan terjangkau. Direktorat Bina Produksi dan Distribusi Alat Kesehatan memiliki tanggung jawab dalam hal pemberian sertifikat produksi, izin penyalur alat kesehatan, izin edar serta pembinaan, pengendalian, dan pengawasan alat kesehatan dan PKRT yang beredar dalam wilayah Republik Indonesia. Tugas khusus ini bertujuan untuk mempelajari dan memahami pedoman ISO 13485 sebagai petunjuk sistem mutu untuk industri alat kesehatan. Sistem manajemen mutu yang baik diperlukan bagi industri alat kesehatan agar alat kesehatan yang diproduksi atau didistribusikan dapat diterima dan diberi izin edar di Indonesia

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Every human being has equal rights in obtaining access to resources in the field of health and health care services that are safe, high quality, and affordable. at Directorate Production and Distribution Medical Devices, General Directorate of Pharmacy And Medical Devices, Ministry of Health Republic of Indonesia have a responsibility in terms of certification of production, medical equipment dealers, permission on marketing authorization and the construction, control and supervision of medical devices and a recommendation for circulating within the territory of the Republic of Indonesia. The special task aims to study the guidelines of ISO 13485 : a Complete Guide to Quality Management in the Medical Device Industry, as a guidance system for industrial quality medical devices. The quality management system is needed for medical device industry that medical devices are manufactured or distributed may be accepted and given a marketing authorization in Indonesia.