Regulation for Registration of Medical Devices Article 11

When applying for registration and market approval, change of registration, or extension of permit license validity for a medical device using bovine or ovine/hircine tissues, the applicant shall attach an explanation of animal raw material source control procedures and proof of raw material source from the original manufacturer in order to verify that the processes associated with the medical device and the ultimate finished product do not use any bovine or ovine/hircine product from the bovine spongiform encephalopathy (BSE) epidemic areas announced by the Council of Agriculture, Executive Yuan, and have not been contaminated by BSE pathogens.For the applications conforming to the announcement from the central health competent authority regarding the exemption from submitting the documentation in the preceding paragraph after considering the international regulatory guidelines for controlling bovine or ovine/hircine tissues in accordance with the risk of contamination of the tissues by BSE pathogen, this provision shall not apply.