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The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. In 2015, Chinese GCP guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some good clinical practices (GCP) are overturning common ways that were implemented since 2003. The CFDA is enhancing inspective forces on the quality and integrity of clinical trial outcomes. GCP requirements on medical devices and diagnostics have also been strengthened by CFDA. The procedures of IND/NDA review and approval have been greatly reformed.  The quality of trial data is becoming more essential as evidence of supporting NDA approval.  All of these updates are sure to impact the IND/NDA drug and medical devices/diagnostic strategies in China. This tutorial will provide insights into critical considerations impacting IND/NDA practices involving drugs and medical devices/diagnostics development in China and upcoming CFDA reformations of regulatory submission review and approval.