Bio-one公司专业提供境内外医疗器械注册代理的全程服务。
Bio-one Company offers all of agency services about import medical device registration in SFDA.
优质！专业！便捷！高效！
Excellent! Professional! Convenient! Efficient!
服务内容：
Service content
1. 专业翻译英文资料；
1. Professional translation of English material
2. 协助整理和准备申报注册的全部文件、材料；
2. Organize and prepare all the documents and materials about registration in SFDA.
3. 接受生产企业委托，组织专家撰写注册产品标准；
3. Draft the registration product standard after entrusted by manufacturer.
4. 代理产品（检测样品）在SFDA认可的检测中心检测、领取检测报告；
4. Send the sample to Medical Devices Testing Center approved by SFDA to test, and obtain the test report.
5. 对于国内没有设立代表处或尚未确定“售后服务机构”的境外生产企业，可委托本公司为“代理人” 或“售后服务机构”，并承诺日后按境外生产企业的要求变更“代理人”、“售后服务机构”。
5. If there is no representative office or after-sales service agency appointed by overseas manufacturer in China mainland, we could be entrusted to act as temporary agent and after-sales service agency.
6. 代理申报注册、定期报告注册审批进度；
6. Act for registration and report the registration status periodically.
7. 如申报产品需经专家论证、审评，协助整理和准备审批会的材料；
7. Prepare the documents for argument and evaluation by experts.
8. 按时交付产品注册证书。
8. Deliver the SFDA Medical Device Registration Certificate of Import on time.
注册进行项目案例：
Ongoing cases
美国原产呼吸功能检测仪 II 类
CHARTISTM Console Class II U.S.A.
美国原产专用导管 III 类
CHARTISTM Catheter Class III U.S.A.
成功案例：
Successful cases
德国尿动力分析仪 II类
Urodynamic System Class II Germany
美国呼吸功能检测仪 II类
REMstar M series CPAP system Class II U.S.A.
加拿大13C幽门螺杆菌检测仪 II 类
Heliprobe Analyze Class II Candia
瑞典14C幽门螺杆菌检测仪 II类
Heliprobe Analyzer Class II Sweden
美国13C 特药注册 进口药品类
Urea-13C U.S.A.
美国 幽门螺杆菌检测试剂盒 试剂类
BioSign H.pylori WB regent U.S.A.
……
Bio-one公司仅收取代理费，其他注册费用一律凭发票收取。
Bio-one company only receives the agent fee.
Other registration fees shall be charged with invoices.
|
