Medical device approval process in China since the introduction of the China Food and Drug Administration
Open accessAbstract
China's medical device market is continuously growing since the last decade and increasingly attractive for foreign medical device manufacturers. However, marketing products in China as a foreign manufacturer is challenging due to the rapidly changing regulatory environment and lack of available information and documents published in English. This work addresses the recent introduction of the China Food and Drug Administration (CFDA) and presents the current CFDA approval processes and required documentation based on research of the original documents of the CFDA in Chinese language.
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In China, increases in Food and Drug Administration scope of practice contributed to a shortage of experts and increased workload of FDA officials, which compromised enforcement of policies regulating antibiotics supply.
“In China, for instance, increases in Food and Drug Administration scope of practice [58, 59] contributed to the shortage of experts and increased workload of Food and Drug Administration officials, which in turn compromised the enforcement of policies regulating antibiotics supply.”
Cites
中華人民共和国国家統計局 (1988) · Medical Entomology and Zoology · Cited by 12,443 · see citing works
Regulation of Medical Devices in the United States and European Union
Kramer, D. B., Xu, S., & Kesselheim, A. S. (2012) · New England Journal of Medicine · doi:10.1056/nejmhle1113918 · Cited by 272 · see citing works
Regulation of medical devices outside the European Union
Lamph, S. (2012) · Journal of the Royal Society of Medicine · doi:10.1258/jrsm.2012.120037 · Cited by 88 · see citing works
Kramer, D. B., Tan, Y. T., Sato, C., & Kesselheim, A. S. (2014) · PubMed · Cited by 64 · see citing works
Medical device regulation for manufacturers
McAllister, P. L., & Jeswiet, J. (2003) · Proceedings of the Institution of Mechanical Engineers Part H Journal of Engineering in Medicine · doi:10.1243/09544110360729090 · Cited by 38 · see citing works
The China Food and Drug Administration (CFDA)
Tan, Y., Xie, Y., Qiao, X., & Bai, S. (2015) · Springer eBooks · doi:10.1007/978-3-319-15576-0_3 · Cited by 19 · see citing works
Zhang, S., Kriza, C., Kolominsky‐Rabas, P. L., & EMN’), (. B. O. T. N. L.-E. C. M. T. ‘. V. (2014) · Expert Review of Medical Devices · doi:10.1586/17434440.2014.932688 · Cited by 9 · see citing works
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Belachew, S. A., Hall, L., Erku, D. A., & Selvey, L. A. (2021) · BMC Public Health · doi:10.1186/s12889-021-11163-3 · Cited by 73 · see citing works
“In China, for instance, increases in Food and Drug Administration scope of practice [58, 59] contributed to the shortage of experts and increased workload of Food and Drug Administration officials, which in turn compromised the enforcement of policies regulating antibiotics supply.”
BackgroundRoohani, I., Newsom, E. T., & Zreiqat, H. (2023) · International Materials Reviews · doi:10.1080/09506608.2023.2194744 · Cited by 46 · see citing works
- Authors
- Lueddemann, T., Chang, D., Sahin, S., & Lueth, T. C.
- Affiliations
- Technical University of Munich (DE)
- ORCID
- Lueth, Tim C.
- Venue
- 2016 IEEE Symposium on Product Compliance Engineering (ISPCE)
- Publisher
- IEEE
- Published
- 2016-05
- Pages
- 1-6
- OpenAlex
- W2437059920
- Cited by
- 2
- References
- 7
- Citations by year
- 2023: 1 · 2021: 1
- FWCI
- 0.00
- Type
- conference paper
- Language
- en
- Open access
- green
- mediatum.ub.tum.de
- Licence
- other-oa
- Locations
- IEEE Symposium on Product Compliance Engineering (ISPCE) (publishedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion, other-oa)
- Topics
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- medical device regulation, regulatory approval process, China Food and Drug Administration, regulatory documents
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