[图文]医疗器械注册管理办法(中英文)-2004

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医疗器械注册管理办法(中英文)-2004

医疗器械注册证
医疗器械注册证医疗器械注册管理办法(中英文)-2004

国家食品药品监督管理局令

Domestic Class I medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authority of the government of the municipalities consisting of districts.

境内第一类医疗器械为注册审批部门所在的省、自治区、直辖市简称加所在设区的市级行政 区域的简称,为××1(无相应设区的市级行政区域时,仅为省、自治区、直辖市的简称); ×2为注册形式(准、进、许):

注册产品标准应当依据国家食品药品监督管理局规定的医疗器械标准管理要求编制。

Imported medical device registration shall perform “ Imported Medical Device Registration Testing Regulation” .

applying medical devices do not have changes concerning safety and effectiveness areas or despite of having changes concerning safety and effectiveness areas which have been tested by medical device testing institution.

(四)申请重新注册的医疗器械在原医疗器械注册证书有效期内按照规定进行医疗器械不良 事件监测,并且未发现不良事件;

第十八条 在中国境内进行临床试验的医疗器械,其临床试验资料中应当包括临床试验合 同、临床试验方案、临床试验报告。

人《补正材料通知书》,一次性告知申请人需要补正的全部内容,逾期不告知的,自收到申请材 料之日起即为受理;

国家食品药品监督管理局应当自受理申请之日起 90个工作日内,作出是否给予注册的决 定。

technical supporting material that shall be inspected by SFDA, finally SFDA will give a decision.

第三十一条 国家食品药品监督管理局应当定期在其政府网站上公布已经获准注册的医疗 器械目录,供公众查阅。

catalog changes, manufacturers shall apply for alteration and re-register according to the changed catalog in concerning regulatory authority of the government.

Literal alteration of product name and trade name.

变更后的医疗器械注册证书的有效期截止日与原医疗器械注册证书的有效期截止日相同,有 效期满应当申请重新注册。

第四十五条 有《中华人民共和国行政许可法》第七十条情形之一的,原注册审批部门 应当依法注销医疗器械注册证书。

第四十九条 违反本办法第三十八条的规定,未依法办理医疗器械注册证书变更的,由县级 以上(食品)药品监督管理部门责令限期改正或者给予警告;逾期不改正的,可以处以 5000元 以上 1万元以下罚款。

第五十六条 本办法自公布之日起施行。

国家药品监督管理局于 2000年 4月 5日发布的《医 疗器械注册管理办法》同时废止。

Applicant documentation requirements of medical device certificate alteration 11.补办医疗器械注册证书申请材料要求

Array

Array

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质量责任的声明以及有关产品型号、规格划分的说明。

Include manufacturing license, Counterpart of Business License, and the applying products falls into the approved manufacturing scope of manufacturing license;

registration standard, the report shall be signed by main testing personnel or main testing responsible personnel, and auditor.

应当包括所提交材料的清单、生产企业承担法律责任的承诺。

responsibilities of entering into market, and a classification illustration of concerning product models, specifications.

If falling into this method Clause 33, please submit original medical device registration copy certificate. If falling into this method Clause 34 and Clause 35, please submit the original medical device registration certificate.

(七)医疗器械说明书;

(二)医疗器械生产企业资格证明;

in China and the user manual of Class I does not need to be singed.

report bad events of medical device and be responsible to communicate with food drug administration.

(一)境外医疗器械注册申请表;

The user manual of Class II and Class III shall be singed by manufacturer or its agency located in China and the user manual of Class I does not need to be singed.

代理人的承诺书所承诺的内容应当与生产企业委托书中委托的事宜一致。

代理人还应当在承 诺书中承诺负责报告医疗器械不良事件,并负责与(食品)药品监督管理部门联系;

All the files above mentioned shall have Chinese version. For the annex 2 and 4, the files would be copies, but have to be notarized by original organization that issuing them or by local notary public. Other files in this annex must be submitted the original files signed by manufacture or its office in Beijing or representative.

abilities (testing resources are included.)

responsibilities by manufacturer.

采用国家标准、行业标准作为产品的适用标准的,应当提交所采纳的国家标准、行业标准的文 本;注册产品标准应当由生产企业签章。

its representative in China )