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Introduction and Discussion of IMDRF Personalized Medical Device Regulatory Pathways / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation ; (6): 669-673, 2023.
Article in Chinese | WPRIM | ID: wpr-1010259
ABSTRACT
OBJECTIVE@#To interpret the key contents of the guidance of Personalized Medical Device Regulatory Pathways issued by the IMDRF, and provide reference for the improvement of China's medical device regulatory system.@*METHODS@#The regulatory requirements of personalized medical devices and point-of-care manufacture of medical device were described respectively, and the feasibility of implementing the regulation of point-of-care manufacture of medical device in China was analyzed.@*RESULTS@#The different regulatory pathways of medical devices produced at point-of-care are feasible and have different regulatory risks.@*CONCLUSIONS@#In combination with the recommendations provided by the IMDRF guidance and the clinical and regulatory realities in China, we should accelerate the improvement of the regulations and supporting documents for point-of-care manufacture of medical device in China.
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Full text: Available Index: WPRIM (Western Pacific) Main subject: China / Commerce / Medical Device Legislation Country/Region as subject: Asia Language: Chinese Journal: Chinese Journal of Medical Instrumentation Year: 2023 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: China / Commerce / Medical Device Legislation Country/Region as subject: Asia Language: Chinese Journal: Chinese Journal of Medical Instrumentation Year: 2023 Type: Article