Medical Devices Act Article 19

For medical devices with certain risk class as announced by the central competent authority, medical device firms and medical institutions shall establish and maintain data on direct supply sources and flow of products.For product items announced by the central competent authority, data established and maintained according to the preceding paragraph shall be reported to the central competent authority.Regulations governing the scope, methods for establishment and maintenance of data, retention period, report contents and methods referred to in the preceding two paragraphs, and other matters to be complied with shall be established by the central competent authority.