浅谈如何做好医疗器械注册工作

Discussion about the Registration and Declaration of Medical Devices

本文介绍了我国医疗器械注册的有关法规与要求,并结合笔者自身申报注册经验简要介绍境内二类医疗器械注册的有关程序、要求及注意事项,并对做好相关工作提出建议。

Introduce the laws and legislation on registration and declaration of medical devices, recommend the procedure, requisition, points for attention about the registration and declaration of the class, medical devices in China, talk about how to deal with it.