Taiwan Issues Guidance on In-Vitro Companion Diagnostic Devices (CDx) 16

The Taiwan FDA issues on 16 July 2020 the guidance on in-vitro companion diagnostic devices (CDx), which are aimed to provide a reference on device efficacy and safety for manufacturers in product development and registration. The guidance is prepared according to other references from the United States, European Union, Japan and Asian Harmonization Working Party (AHWP).

The document published detailed instructions aimed at manufacturers involved in product development and registration. The scope of content in the document includes key issues during the research and development phase of IVD-CDx, definition terms of IVD-CDx, instructions on registration and regulatory review of IVD-CDx, all of which are focused to strengthen the administration of in vitro Companion Diagnostic Devices (IVD-CDx)

More information could be accessed from this link:-
伴隨式體外診斷醫療器材技術基準
Taiwan FDA announcement no.1091606071
FDA器字第1091606071號公告
https://www.fda.gov.tw/TC/siteListContent.aspx?sid=310&id=33957

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