为贯彻实施《医疗器械监督管理条例》(国务院令第650号,以下简称《条例》),进一步明确产品技术要求有关问题,食品药品监管总局办公厅将有关事项通知如下:一、《条例》中明确了产品技术要求的法律地位。第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交产品技术要求等资料;医疗器械生产企业应当严格按照经注册或者备案的产品技术要求组织生产,保证出厂的医疗器械符合强制性标准以及经注册或者备案的产品技术要求。二、医疗器械注册申请人应当根据医疗器械成品的性 In order to implement the “Regulations on the Supervision and Administration of Medical Devices” (Decree No. 650 of the State Council, hereinafter referred to as the “Regulations”) and further clarifying the relevant technical requirements of products, the General Office of Food and Drug Regulatory Affairs will notify the relevant matters as follows: I. In the Regulations Clarified the legal status of product technical requirements. The first class of medical device products for the record and apply for the second class, the third class of medical device product registration, product technical requirements should be submitted and other information; medical device manufacturing enterprises should be in strict accordance with the registered or filing product technical requirements for production, to ensure that the factory Medical devices comply with the mandatory standards as well as registered or filing product technical requirements. Second, the registration of medical devices Applicants should be based on the nature of medical devices