胶原蛋白类植入性医疗器械及其安全性评价探讨

Development and safety evaluation of implantable medical device of collagen

对已在中国上市的胶原蛋白类植入性医疗器械按生产工艺及性能特征进行了分类，并结合国家食品药品监督管理总局（cFDA）对该类产品的监管要求，从免疫原性风险、病毒及传染性病原体风险、产品技术要求项目等方面探讨了该类医疗器械安全性评价的要点；最后结合生物医学工程、组织工程、基因工程等领域的技术进步对该类医疗器械未来的发展方向进行展望。

This paper categorizes implantable medical device of collagen on Chinese market according to manufacturing technique and performance. Combining with supervision requirements from China Food and Drug Administration （CFDA）, this paper discusses safety evaluation in following aspects, such as immunogenicity risk, virus and infectious pathogen risk, and product technical requirements. Finally, the paper looks into the future of collagen implants considering technology progress in biomedical engineering, tissue engineering, and genetic engineering fields.