第二十九条 （食品）药品监督管理部门应当在行政机关的网站和医疗器械注册办公场所公示相应的医疗器械注册所需的条件、程序、期限、需要提交的全部材料的目录和申请书示范文本等。
SFDA shall issue the condition, procedure, time limit, all requested material directory, samples of application letters of medical devices registration on administrative website and registration handling area.
第三十条 （食品）药品监督管理部门对医疗器械注册申请进行审查时，应当公示审批过程和审批结果。申请人和利害关系人可以对直接关系其重大利益的事项提交书面意见进行陈述和申辩。
SFDA shall issue publicly of the inspection process and result during the inspection process of medical device application. Applicants and persons concerned would submit paper advice to state and excuse for the badly concerned matter.
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。
SFDA shall regularly issue the approved medical devices list on its government website for public reference.
第三十二条 医疗器械注册申请直接涉及申请人与他人之间重大利益关系的，（食品）药品监督管理部门应当告知申请人、利害关系人可以依照法律、法规以及国家食品药品监督管理局的其他规定享有申请听证的权利；在对医疗器械注册申请进行审查时，（食品）药品监督管理部门认为涉及公共利益的重大许可事项，应当向社会公告，并举行听证。
第五章 医疗器械的重新注册
Chapter 5 Medical device re-registration
第三十三条 医疗器械注册证书有效期届满，需要继续销售或者使用医疗器械的，生产企业应当在医疗器械注册证书有效期届满前6个月内，申请到期重新注册。逾期办理的，重新注册时应当对产品进行注册检测。
Manufacturers shall re-register medical devices certificates within 6 months before expiration date if they would like to sell or use medical devices with overdue certificates.
第三十四条 医疗器械注册证书中下列内容发生变化的，生产企业应当自发生变化之日起30日内申请变更重新注册：
If any content in medical devices certificate listing below has changed, Manufactures shall apply for alteration and re-registration in 30 days from changing.
（一）型号、规格； Specifications, models
（二）生产地址； Manufacturing address
（三）产品标准； Product standards
（四）产品性能结构及组成；
Performance, structure and components of product
（五）产品适用范围。 Indications
第三十五条 医疗器械注册证书有效期内，产品管理类别发生改变的，生产企业应当在6个月内，按照改变后的类别到相应的（食品）药品监督管理部门申请变更重新注册。 During medical device certificate validity period, if the administrative catalog changes, manufacturers shall apply for alteration and re-register according to the changed catalog in concerning regulatory authority of the government.
第三十六条 申请医疗器械重新注册的，应当填写医疗器械注册申请表，并按照本办法附件4、附件5或者附件7的相应要求向（食品）药品监督管理部门提交申请材料。
When applying for re-registration, shall fill in medical device application form and submit application material requested by this method attachment 4,5 or 7 to SFDA.
重新注册的受理与审批程序，本章没有规定的，适用本办法第四章的相关规定。
If there is no regulation on re-registration acceptance and inspection procedure in this chapter, please refer to chapter 4 regulation.
第三十七条 有下列情形之一的医疗器械，不予重新注册： Re-registration is not allowed for any condition below:
（一）未完成（食品）药品监督管理部门在批准上市时按照国家食品药品监督管理局有关规定提出的要求的；
（二）经国家食品药品监督管理局再评价属于淘汰品种的； Belong to out of date catalogs when re-evaluated by SFDA.
（三）按照《医疗器械监督管理条例》的规定撤销医疗器械注册证书的。 Medical device certificates that were withdrawed by SFDA.
第六章 医疗器械注册证书的变更与补办
Alterating and Supplementing of medical device certificates
第三十八条 医疗器械注册证书载明内容发生下列变化的，生产企业应当自发生变化之日起30日内申请医疗器械注册证书变更：
Any content listed in medical device has changed, manufactures shall apply for alteration registration on medical device registration certificates within 30 days from the altering date.
生产企业实体不变，企业名称改变；
Manufacture substantiality does not change, name has been altered.
生产企业注册地址改变；
Manufacture registered address has been altered.
生产地址的文字性改变；
Literal alteration of manufacturing address.
（四） 产品名称、商品名称的文字性改变； Literal alteration of product name and trade name.
（五） 型号、规格的文字性改变 ； Literal alteration of specifications and models.
（六） 产品标准的名称或者代号的文字性改变； Literal alteration of name or code of product standard.
（七） 代理人改变； Agent changes.
（八） 售后服务机构改变。 After sales service changes.
第三十九条 申请医疗器械注册证书变更的，应当填写医疗器械注册证书变更申请表，并按照本办法附件10的要求向原注册审批部门提交有关材料和说明。原注册审批部门对申请材料进行形式审查，当场或者在5个工作日内一次性告知申请人需要补正的全部内容，符合要求的发给《受理通知书》。
Applying for the alteration registration, should fill in medical device registration certificate alteration application form and submit concerning material and explanation to original registration inspection department according to this method attachment 10. Original registration inspection department shall inspect the format of material or inform applicants with all material requested to supplement on spot or within 5 workdays. Submit ‘acceptance letter ’ if all material according with requirements.
第四十条 原注册审批部门受理变更申请后，应当在20个工作日内作出是否同意变更的书面决定。经审查符合规定予以变更的，发给变更后的医疗器械注册证书，并对原医疗器械注册证书予以注销。经审查不符合规定的，作出不予变更的书面决定，并说明理由，同时告知申请人享有依法申请行政复议或者提起行政诉讼的权利。
Original registration inspection department shall issue a paper decision notice on whether agree to do alteration registration within 20 workdays from the date of accepting alteration application. If the alteration registration application is accord with regulation after being inspected, registration inspection department shall issue the altered medical device registration certificate and log out the original certificate. If the application is not accord with regulation after being
inspected, the department shall make a unaccepted paper notice, explain the reason and inform the applicant that they have the legal right of applying for administrative re-inspection or administrative litigation.
变更后的医疗器械注册证书用原编号，编号末尾加带括号的“更”字。
The altered medical device registration certificates would use the original number, character ‘更’should be attached to the end of the number.
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。
The altered medical device registration certificates shall have the same expiration date with the original certificates and shall be applied for re-registration after the expiration date .
第四十一条 医疗器械注册证书丢失或损毁的，生产企业应当按照本办法附件11的要求提交有关材料和说明，向原注册审批部门申请补办。
If medical device registration certificates are lost or damaged, manufactures shall submit material and explanation to original registration inspection department to apply for new transaction.
第七章 监督管理
Chapter 7 Supervision Administration
第四十二条 负责医疗器械注册审批的（食品）药品监督管理部门应当按照规定程序进行审批，并作出是否给予注册的决定。对违反规定审批注册的，应当依法追究其行政责任。 Food drug supervision administration department in charge of medical device registration inspection shall do inspection according to regulated procedure and make notice whether to admit registration. Who offend regulation shall be run relative obligation legally.
第四十三条 设区的市级以上地方（食品）药品监督管理部门违反本办法规定实施的医疗器械注册，由其上级（食品）药品监督管理部门责令限期改正；逾期不改正的，上级（食品）药品监督管理部门可以直接公告撤销该医疗器械注册证书。已经被撤销医疗器械注册证书的医疗器械不得继续销售和使用，已经销售、使用的，由县级以上地方（食品）药品监督管理部门负责监督企业进行处理。
If the food drug regulatory authority of the government above the municipalities consisting of districts offend the regulated methods and shall be corrective by the superior food drug administration department shall in time limit. If not be corrective in time limit, the superior would proclaim directly to withdraw medical device certificates. The withdraw certificates would not be sold or used, and the sold and used products shall be transacted by food drug regulatory authority above county.
第四十四条 省级以上（食品）药品监督管理部门对上市后的医疗器械进行技术再评价，并根据技术评价的结果对不能达到预期使用目的、不能保证安全有效的医疗器械，作出撤销医疗器械注册证书的决定，并向社会公告。已经被撤销医疗器械注册证书的医疗器械不得继续销售和使用，已经销售、使用的，由县级以上地方（食品）药品监督管理部门负责监督企业进行处理。
Food drug regulatory authority above province shall do technical re-evaluation for the marketed medical devices, and issue a notice of withdraw their medical device certificates and placard to society for those medical devices that can not have the anticipated usage and can not ensure safety and effectiveness .
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。
Any situation belongs to 《PRC Administration Admit Law》item 70, the original registration inspection department shall withdraw medical device certificates legally.
第八章 法律责任
Chapter 8 Legal Responsibility
第四十六条 违反本办法规定，申请医疗器械注册时，采取提供虚假证明、文件、样品等虚假材料，或者以欺骗、贿赂等不正当手段骗取医疗器械注册证书的，注册审批部门不予受理或者不予注册,并给予警告，1年内不受理其医疗器械注册申请；对于其已经骗取得医疗器械注册证书，予以撤销，2年内不受理其医疗器械注册申请，并依照《医疗器械监督管理条例》第四十条的规定予以处罚。
Registration inspection department shall not accept or not admit registration and give warning, will not accept medical device registration application within 1 year if there is any situation belonging to the below: offend this regulated method, submit fake evidence, documentation and samples etc when applying for medical device registration or diddle medical device registration certificates by shocking ways of cheating or bribe. For the diddled certificates, they should be withdraw and would not applied for medical device registration application within 2 years, meanwhile will be punished by the regulation of ‘Medical Device Supervision Administration Regulation ’ article 40.
第四十七条 涂改、倒卖、出租、出借医疗器械注册证书，或者以其他形式非法转让医疗器械注册证书的，由县级以上（食品）药品监督管理部门责令改正，可以并处3万元以下罚款。
For altering, buying and selling at a profit, renting or borrowing medical device certificates or other illegally forms to transfer certificates, food drug regulatory authority above the county government shall force them to corrective and fine under RMB30000.
第四十八条 违反本办法第三十三条、第三十四条或者第三十五条的规定，未依法办理医疗器械重新注册而销售的医疗器械，或者销售的医疗器械与注册证书限定内容不同的，或者产品说明书、标签、包装标识等内容与医疗器械注册证书限定内容不同的，由县级以上（食品）药品监督管理部门依照《医疗器械监督管理条例》关于无医疗器械注册证书的处罚规定予以处罚。
Food drug regulatory authority above province government shall punish according to the punishment regulation on without certificate of 《Medical Device Supervision Administration Regulation》for any of the following situation, that is disobeying article 33,34 or 35 of this method, not doing medical device re-registration but selling, the sold medical devices are not same to the limited content in the registration certificate or products user manual, labeling, package etc are