医疗器械标准在中美医疗器械监管领域的实践和发展思考

目的：为医疗器械标准在医疗器械监管领域的应用和发展提供参考。方法：总结我国医疗器械标准的分类及应用要求、标准符合性评价方面关于检验报告和检验机构资质的要求；对比美国标准体系下的医疗器械认可推荐性共识标准机制及其对医疗器械检验实验室的要求，并介绍了美国食品药品管理局在有关标准符合性评估方面的合格评定计划；总结分析两国监管的异同，提出未来医疗器械监管发展中标准与专利融合的必要性。结果与结论：中美两国在医疗器械标准监管的管理模式上有诸多不同，但本质上也有许多相似之处。我国医疗器械领域标准的监管在未来的发展中应着眼于提升产业核心竞争力，广泛采用国际标准和发达国家的先进标准，并重视对先进技术和专利的吸纳以及向国际标准的转化，以期提升器械监管水平，促进我国医疗器械行业的高水平发展。

Analysis and Reflection on the Practice and Development of Medical Device Standards in the Field of Medical Device Supervision in China and USA

Objective: To provide perspective for the application and development of medical device standards in the fi eld of medical device supervision. Methods: The classifi cation and application requirements of medical device standards in China were summarized. The requirements of medical device inspection reports and relevant qualifi cation of inspection institutions in terms of standard conformity evaluation have been summarized, further compared with standards system of Medical Device Recognized Recommended Consensus Standards in USA and its requirements about medical device testing laboratories and FDA''s Accreditation Scheme for Conformity Assessment (ASCA) in the evaluation of standard conformity were introduced. The similarities and diff erences between the two countries were summarized and analyzed. The necessity of the integration of standards and patents in the future development of medical device supervision was proposed. Results and Conclusion: While there are obvious diff erences between the management mode of medical device standards supervision system in China and the USA, there are some similarities in essence as well. In order to pursue a higher management level and promote the medical device industry development, the supervision of medical device standards in China in the future development should focus on enhancing the core competitiveness of the medical device industry, widely adopt international standards and relative advanced standards in developed countries, and attach importance to the absorption of advanced technology and patents and the transformation to international standards in advance.