浅谈动物源性医疗器械的产业发展和监管现状

An Overview on Industrial Development and Regulations for Animal-derived Medical Devices

目的为动物源性医疗器械产业发展、法律法规建设和标准体系的完善提供参考。方法介绍了动物源性医疗器械产业发展的现状和趋势;概述了相关法规要求和现行标准体系;重点阐述了相关法规和标准中对风险控制的通用技术要求;同时分析了动物源性医疗器械特殊的免疫毒性风险和免疫毒性评价中技术的瓶颈问题。结果与结论动物源性医疗器械的产品种类、应用范围呈现不断增加趋势,为相关生产企业、研究人员、检测与监管人员提供综合信息具有重要的现实意义。

medical devices Objective To provide references for the derived from animals and the gradual development of the manufacturing industry of perfection of relevant laws, regulations and systematic standards. Methods This review outlined the current development and trend of the manufacturing industry of medical devices derived from animals, summarized the relevant statutory requirements and the current systematic standards. Special efforts were devoted to explaining the general technical requirements for controlling risks under the regulations and standards. In addition, it analyzed the special immunotoxicity risks posed by medical devices derived from animals and the bottleneck issues for the immune toxicity evaluation technology. Results and Conclusion The types of medical devices derived from animals are continuously on the rise with expanding application range. In this background, this paper provided comprehensive information not only for the manufacturers and researchers, but also for the supervisors and experts who perform the pre-clinical evaluation or registration evaluation.