not same to the limited content in the medical device registration certificates.
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。
Food drug regulatory authority above province government shall force to corrective or warn that violating article 38 of this method and do not do registration alteration. The government shall fine above RMB5000 under RMB10000 that exceeding the time limit.
第五十条 根据本办法第十五条申请注册后再对产品进行注册检测的医疗器械，未按照规定完成注册检测即将产品投入使用的，由国家食品药品监督管理局撤销医疗器械注册证书，予以公告，并记入企业诚信档案。
According to the Clause 15 of the method, the product which applied postponed testing after receiving certificate, but to be used before promised testing, the certificate of the product will be withdraw and publicized, and the issue will be put into the enterprise faith record.
产品经注册检测不合格的，由国家食品药品监督管理局撤销医疗器械注册证书。
If the registration testing is ineligible, State Food Drug Supervision Administration Department shall withdraw medical device certificates.
第九章 附则
Chapter 9 Attachment
第五十一条 生产企业系指以自己名义把产品推向市场，并对产品负最终法律责任的机构。
Manufacturers mean who push product to market and will take legal responsibility for product.
第五十二条 注册产品系指获准注册的医疗器械及其说明书、标签、包装标识等有关内容与该医疗器械注册证书限定内容一致的产品。
Registration products mean the registered medical device and medical devices that their user manual, labeling, package etc accord with content limited on medical device certificate.
第五十三条 在医疗器械注册证书有效期内生产的医疗器械都视为有证产品。
Medical devices which manufacture within the validity date shall be regarded as licensed products.
第五十四条 按医疗器械注册管理的体外诊断试剂，其注册管理规定由国家食品药品监督管理局另行制定。
In vitro agent which be registered according to medical device registration administration, its registration administration regulation shall be set separately.
第五十五条 本办法由国家食品药品监督管理局负责解释。 This method shall be explained by State Food Drug Administration.
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。
The regulations shall come into force from the proclamation date. The regulation of 《Medical Device Registration Administration Regulation》 issued at April 5th 2000 shall be abolished synchronously.
附件：
Attachment:
1．医疗器械注册登记表格式
Medical Devices Registration Record Format
2．境内第一类医疗器械注册申请材料要求
Registration applicant documentation requirements for domestic Class I medical device
3．境内第二类、第三类医疗器械注册申请材料要求
Registration applicant documentation requirements for domestic Class II, III medical device
4．境内第一类医疗器械重新注册申请材料要求
Re-registration applicant documentation requirements for domestic Class I medical device
5．境内第二类、第三类医疗器械重新注册申请材料要求
Re-registration applicant documentation requirements for domestic Class II, III medical device
6．境外医疗器械注册申请材料要求
Registration applicant documentation requirements for overseas medical device
7．境外医疗器械重新注册申请材料要求
Re-registration applicant documentation requirements for overseas medical device
8．未获得境外医疗器械上市许可的第一类境外医疗器械首次注册申请材料要求
First registration applicant documentation requirements of overseas Class I medical device without overseas market approval.
9．未获得境外医疗器械上市许可的第二类、第三类境外医疗器械首次注册申请材料要求 First registration applicant documentation requirements of overseas Class II,III medical device without overseas market approval.
10．医疗器械注册证书变更申请材料要求
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
12．医疗器械注册临床试验资料分项规定
Medical device registration clinical trial material itemized regulation
附件1:
Attachment 1:
医疗器械注册登记表格式
Medical Devices Registration Record Format
（一）境内医疗器械注册登记表格式：
Domestic Medical Devices Registration Record Format
医疗器械注册登记表
Medical Devices Registration Record Sheet
Reg ：×（×）1（食）药监械（准）字××××3第×4××5××××6号 生产企业名称 Manufacturer 企业注册地址
Company Registration Address 生产地址
Manufacturing Address 产品名称
Product Name
型号、规格
Specification, Model 产品标准
Product Standard 产品性能结构及组成
Performance, structure and components of the product
产品适用范围 Indications 产品禁忌症
Contraindication
备 注
Notes ××××年×月×日
（二）境外医疗器械注册登记表格式：
Overseas Medical Devices Registration Record Format
医疗器械注册登记表
Overseas Medical Devices Registration Record
注册号：国食药监械（进）字××××3第×4××5××××6号 Reg No.
REG.NO.：SFDA（I）××××3×4××5××××6 生产企业名称
MINUFACTURER 企业注册地址
MANUFACTURER’S ADDRESS 生产地址
ADDRESS OF MANUFACTURING SITE 产品名称
NAME OF DEVICE 型号、规格 MODEL
产品标准
PRODUCT STANDARDS
产品性能结构及组成PERFORMANCE，STRUCTURE AND COMPONENTS OF THE PRODUCT 产品适用范围 INDICATIONS 产品禁忌症
CONTRAINDICATIONS 代理人 AGENT 售后服务机构
SERVICE AGENT（S） 备 注
NOTES ××××年×月×日
（三）台湾、香港、澳门地区医疗器械注册登记表格式：
Medical Devices Registration Record Format of Taiwan, Hongkong, Macao
医疗器械注册登记表
Medical Devices Registration Record
注册号：国食药监械（许）字××××3第×4××5××××6号 Reg No:
生产企业名称
MINUFACTURER 企业注册地址
MANUFACTURER’S ADDRESS 生产地址
ADDRESS OF MANUFACTURING SITE 产品名称
NAME OF DEVICE 型号、规格 MODEL 产品标准
PRODUCT STANDARDS
产品性能结构及组成
PERFORMANCE，STRUCTURE AND COMPONENTS OF THE PRODUCT 产品适用范围 INDICATIONS 产品禁忌症
CONTRAINDICATIONS 代理人 AGENT
售后服务机构
SERVICE AGENT（S） 备 注
NOTES ××××年×月×日
附件2： Annex 2:
境内第一类医疗器械注册申请材料要求
Registration applicant material requirement of domestic Class I medical device
（一）境内医疗器械注册申请表；
Domestic Medical Device Registration Applying Form
（二）医疗器械生产企业资格证明： Qualification of Medical Device Manufacturer
营业执照副本； Counterpart of Business License
（三）适用的产品标准及说明： Applied product standard and illustration
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。
If manufacturer adopt national standard or industrial standard as the applied product standard, the manufacturer shall provide concerning copy of National standard or industrial standard; Registration product standard shall be signed/chopped by manufacturer.
生产企业应当提供所申请产品符合国家标准、行业标准的声明，生产企业承担产品上市后的质量责任的声明以及有关产品型号、规格划分的说明。