Brief Introduction to Regulatory Documents of European and American Drug-Device Combinations and Enlightenment / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 246-248, 2020.
Article
in Chinese
| WPRIM
| ID: wpr-942736
ABSTRACT
This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
United States
/
Marketing
/
European Union
Country/Region as subject:
North America
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2020
Type:
Article
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