Acceptance of overseas clinical trial data of medical devices for pre-market registration: general principles and considerations of the National Medical Products Administration

• Published in: Chinese medical journal Vol. 134; no. 18; pp. 2163 - 2165
• Main Authors: Ju, Shan, Liu, Ying-Hui, Zhang, Yi-Dan, Wu, Chuan-Song, Xiao, Li, Sun, Lei
• Format: Journal Article
• Language: English
• Published: China Lippincott Williams & Wilkins 07.07.2021; Lippincott Williams & Wilkins Ovid Technologies; Wolters Kluwer
• Subjects: Clinical medicine; Clinical trials; Disease; Ethics; Genetic disorders; Human subjects; Influence; Jurisdiction; Medical equipment; Medical technology; Mutation; Principles; Registration; Viewpoint; China

Medical devices differ in mechanisms of action in or on the human body, type, and duration of contact with the human body, and expected clinical effects. [...]a medical device may have different risks and clinical performances across populations. The working mechanism is based on time-dependent chan...