[Brief Introduction to Regulatory Documents of European and American Drug-Device Combinations and Enlightenment]

Qingfeng Luo; Jiaxin Tian; Yongqing Wang

doi:10.3969/j.issn.1671-7104.2020.03.012

[Brief Introduction to Regulatory Documents of European and American Drug-Device Combinations and Enlightenment]

Zhongguo Yi Liao Qi Xie Za Zhi. 2020 Mar 8;44(3):246-248. doi: 10.3969/j.issn.1671-7104.2020.03.012.

[Article in Chinese]

Authors

Qingfeng Luo¹, Jiaxin Tian¹, Yongqing Wang¹

Affiliation

¹ Center for Medical Device Evaluation, NMPA, Beijing, 100081.

PMID: 32621434
DOI: 10.3969/j.issn.1671-7104.2020.03.012

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.

Keywords: drug-device combinations; enlightenment; supervision.

MeSH terms

European Union
Marketing*
United States