医疗器械注册管理办法
Medical Devices Registration Administration Method
总则Chapter 1 General Provisions
　　第一条　为规范医疗器械的注册管理,保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device， we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.
　　第二条　在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械,不得销售、使用.
Article 2 All the medical device which would like t ...