医疗器械产品说明书编写规范探讨

Discussion on the Preparation of Medical Device Instruction Manual

根据《医疗器械监督管理条例》《医疗器械注册管理办法》,基于现行有效的国家标准、行业标准的要求,结合注册技术审评的经验对医疗器械说明书的法律法规、常见问题、变更事项等方面进行探讨分析。

We analyse medical device including laws and regulations,general issues,change requests according to medical device supervision,administration regulations and medical device registration management measures,based on the current valid national standards,industry standards and mandate of technical evaluation.