苏州益融疗器械技术服务有限公司专注于苏州、无锡、常州、南通、泰州、浙江等地疗器械注册证、疗器械经营许可证、器械生产备案、疗器械生产许可证、器械广审查表、网络销售备案、疗器械ISO13485 YY/T0287质量管理体系、疗器械欧盟CE认证以及美国FDA注册方面的辅导服务。
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服务内容:
Service content:
1. 专业翻译外文资料;
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技术要求;
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ZX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. 交付产品注册证书。
8. Deliver the SFDA Medical Device Registration Certificate of Import on time.
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