【CODEX】2014 No.4 医疗器械注册管理办法（8-11）-EN
第八章 产品备案
Chapter VIII Product Filing
第五十七条 第一类医疗器械生产前，应当办理产品备案。
Article 57.Filing for a Class I medical device shall be conducted prior to production.
第五十八条 办理医疗器械备案，备案人应当按照《医疗器械监督管理条例》第九条的规定提交备案资料。
Article 58.For a medical device filing, the filing entity shall submit the filing documents in accordance with Article 9 of the Regulations for the Supervision and Administration of Medical Devices.
备案资料符合要求的，食品药品监督管理部门应当当场备案；备案资料不齐全或者不符合规定形式的，应当一次告知需要补正的全部内容，由备案人补正后备案。
Where the filing documents meet the requirements, the food and drug regulatory authority shall complete the filing on the spot. Where the filing documents are not complete or do not meet the filing requirements, the filing entity shall be informed of all the supplements and corrections to be made at one time, and the filing shall be completed upon supplements and corrections.
