Medical device approval process in China since the introduction of the China Food and Drug Administration

Tobias Lueddemann; Diqing Chang; Sadik Sahin; Tim C. Lueth

doi:10.1109/ISPCE.2016.7492842

Medical device approval process in China since the introduction of the China Food and Drug Administration

Tobias Lueddemann, Diqing Chang, Sadik Sahin, Tim C. Lueth

Chair of Micro Technology and Medical Device Technology

Technical University of Munich

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

3 Scopus citations

Abstract

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.

Original language	English
Title of host publication	ISPCE 2016 - Proceedings
Subtitle of host publication	IEEE Symposium on Product Compliance Engineering
Publisher	Institute of Electrical and Electronics Engineers Inc.
ISBN (Electronic)	9781467379014
DOIs	https://doi.org/10.1109/ISPCE.2016.7492842
State	Published - 15 Jun 2016
Event	13th Annual IEEE Symposium on Product Compliance Engineering, ISPCE 2016 - Anaheim, United States Duration: 16 May 2016 → 18 May 2016

Publication series

Name	ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering

Conference

Conference	13th Annual IEEE Symposium on Product Compliance Engineering, ISPCE 2016
Country/Territory	United States
City	Anaheim
Period	16/05/16 → 18/05/16

Keywords

CFDA
China
medical devices
regulatory affairs

Access to Document

10.1109/ISPCE.2016.7492842

Cite this

Lueddemann, T., Chang, D., Sahin, S., & Lueth, T. C. (2016). Medical device approval process in China since the introduction of the China Food and Drug Administration. In ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering Article 7492842 (ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering). Institute of Electrical and Electronics Engineers Inc.. https://doi.org/10.1109/ISPCE.2016.7492842

Lueddemann, Tobias ; Chang, Diqing ; Sahin, Sadik et al. / Medical device approval process in China since the introduction of the China Food and Drug Administration. ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering. Institute of Electrical and Electronics Engineers Inc., 2016. (ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering).

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title = "Medical device approval process in China since the introduction of the China Food and Drug Administration",

abstract = "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.",

keywords = "CFDA, China, medical devices, regulatory affairs",

author = "Tobias Lueddemann and Diqing Chang and Sadik Sahin and Lueth, {Tim C.}",

note = "Publisher Copyright: {\textcopyright} 2016 IEEE.; 13th Annual IEEE Symposium on Product Compliance Engineering, ISPCE 2016 ; Conference date: 16-05-2016 Through 18-05-2016",

year = "2016",

month = jun,

day = "15",

doi = "10.1109/ISPCE.2016.7492842",

language = "English",

series = "ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering",

publisher = "Institute of Electrical and Electronics Engineers Inc.",

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Lueddemann, T, Chang, D, Sahin, S & Lueth, TC 2016, Medical device approval process in China since the introduction of the China Food and Drug Administration. in ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering., 7492842, ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering, Institute of Electrical and Electronics Engineers Inc., 13th Annual IEEE Symposium on Product Compliance Engineering, ISPCE 2016, Anaheim, United States, 16/05/16. https://doi.org/10.1109/ISPCE.2016.7492842

Medical device approval process in China since the introduction of the China Food and Drug Administration. / Lueddemann, Tobias; Chang, Diqing; Sahin, Sadik et al.
ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering. Institute of Electrical and Electronics Engineers Inc., 2016. 7492842 (ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering).

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

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AU - Sahin, Sadik

AU - Lueth, Tim C.

PY - 2016/6/15

Y1 - 2016/6/15

N2 - 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.

AB - 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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DO - 10.1109/ISPCE.2016.7492842

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T3 - ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering

BT - ISPCE 2016 - Proceedings

PB - Institute of Electrical and Electronics Engineers Inc.

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Lueddemann T, Chang D, Sahin S, Lueth TC. Medical device approval process in China since the introduction of the China Food and Drug Administration. In ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering. Institute of Electrical and Electronics Engineers Inc. 2016. 7492842. (ISPCE 2016 - Proceedings: IEEE Symposium on Product Compliance Engineering). doi: 10.1109/ISPCE.2016.7492842

Medical device approval process in China since the introduction of the China Food and Drug Administration

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