Development and safety evaluation of implantable medical device of collagen / 国际生物医学工程杂志

ABSTRACT

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.