摘要
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.
出处
《中国医疗器械信息》
2011年第1期43-45,共3页
China Medical Device Information
关键词
二类医疗器械
注册
法规
class, medical devices, registration, laws and legislation