A regulatory perspective on recombinant collagen-based medical devices

Wenbo Liu; Hai Lin; Peng Zhao; Lina Xing; Jie Li; Zehua Wang; Shan Ju; XinLi Shi; Yinghui Liu; Gang Deng; Guobiao Gao; Lei Sun; Xindong Zhang

Bioactive Materials (Jun 2022)

A regulatory perspective on recombinant collagen-based medical devices

Wenbo Liu,
Hai Lin,
Peng Zhao,
Lina Xing,
Jie Li,
Zehua Wang,
Shan Ju,
XinLi Shi,
Yinghui Liu,
Gang Deng,
Guobiao Gao,
Lei Sun,
Xindong Zhang

Affiliations

Wenbo Liu: Corresponding author.; Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Hai Lin: Corresponding author.; National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China
Peng Zhao: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Lina Xing: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Jie Li: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Zehua Wang: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Shan Ju: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
XinLi Shi: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Yinghui Liu: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Gang Deng: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Guobiao Gao: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Lei Sun: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Xindong Zhang: National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China; Institute of Regulatory Science for Medical Devices & NMPA Research Base of Regulatory Science for Medical Devices, Sichuan University, Chengdu, China

Journal volume & issue: Vol. 12
pp. 198 – 202

Abstract

Read online

As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the definition, translation, classification and technical review. Recombinant collagens are categorized as recombinant human collagen, recombinant humanized collagen and recombinant collagen-like protein, as differentiated by specific compositions and structures. Based on their intended uses and associated risks, recombinant collagen-based medical devices are generally classified as Class Ⅱ or Ⅲ in China. The regulatory review of recombinant collagen-based medical devices aims to assess their safety and efficacy demonstrated by scientific evidences generated from preclinical and clinical evaluations. Taken together, opportunities as well as challenges for their future clinical translation of recombinant collagen-based medical devices abound, which highlights the essential role of regulatory science to provide new tools, standards, guidelines and methods to evaluate the safety and efficacy of medical products.

Published in Bioactive Materials

ISSN: 2452-199X (Online)
Publisher: KeAi Communications Co., Ltd.
Country of publisher: China
LCC subjects: Technology: Electrical engineering. Electronics. Nuclear engineering: Materials of engineering and construction. Mechanics of materials; Science: Biology (General)
Website: https://www.keaipublishing.com/en/journals/bioactive-materials/

About the journal

Abstract

Keywords