优化进口医疗器械产品在我国境内企业生产相关许可事项20200925
发布时间：2020-09-25
为落实“放管服”改革和优化营商环境要求，进一步深化医疗器械审评审批制度改革，国家药监局在充分研究论证的基础上，对已取得我国注册证的进口医疗器械产品在我国境内企业生产，进一步优化相关注册申报资料要求。
国家药监局对已取得进口第二类、第三类医疗器械注册证的产品在我国境内生产申请产品注册时，基于医疗器械科学监管的原则，在主要原材料和生产工艺不发生改变、质量管理体系保持一致的前提下，认可部分原申报资料用于境内生产产品的注册申报，这将有利于节约各方资源、提升审评审批效率，促进我国医疗器械产业快速发展，更好地满足人民群众的用械需求。
下一步，国家药监局将进一步加强相关境内生产产品上市后监管，确保产品质量安全可控。
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