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 Zh
| WPRIM
| ID: wpr-1010259
Responsible library:
WPRO
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.
Key words
Full text:
1
Index:
WPRIM
Main subject:
China
/
Commerce
/
Medical Device Legislation
Country/Region as subject:
Asia
Language:
Zh
Journal:
Chinese Journal of Medical Instrumentation
Year:
2023
Type:
Article