Shang-Ching Lin received his Ph.D. degree in Engineering from National Taiwan University and is currently an Associate Researcher of Taiwan FDA. He devotes himself to regulatory affairs of medical devices and international cooperation in that field, trying to respond to challenges in regulating emerging interdisciplinary medical devices with local and global partners. He now belongs to the post-market surveillance and vigilance team and has several years of practical experiences in regulatory affairs of medical devices, including reviewing clinical investigation plan, changes to approved Class II IVDs, pre-market approval of Class I IVD/MDs, special approval of manufacture/import of medical devices, and conducting GCP inspection. He is also a member of Working Group 2 (Pre-market: IVDD) of Global Harmonization Working Party’s Technical Committee.