With the entry into force of Royal Decree 1591/2009 of 6 November, which regulates medical devices, all products derived from human tissues are no longer conceptualized as medical devices and became considered human tissues. From the entry into force of Royal Decree-Law 9/2014, of 4 July, these products are regulated by the aforementioned Royal Decree, in which the standards of quality and safety for the donation, the procurement, testing, processing, preservation, storage and distribution of human tissues and cells are described.
That is, any dental clinic where these products derived from human tissues are used, shall be authorized to perform this activity by the Directorate General of Planning and Health Regulation Department of Health.
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