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[https://nmpa.gov.cn/xxgk/zwgk/sjspan08/20200219142925286.html](https://nmpa.gov.cn/xxgk/zwgk/sjspan08/20200219142925286.html) 国际 美国食品药品监督管理局 (FDA) 医疗器械注册协同伙伴机构数据库：[https://accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm](https://accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm) 欧盟医疗器械数据库 (EUDAMED)：[https://ec.europa.eu/growth/sectors/medical-devices/eudamed_en](https://ec.europa.eu/growth/sectors/medical-devices/eudamed_en) 加拿大卫生部 (HC) 医疗器械注册合作伙伴机构列表：[https://canada.ca/en/health-canada/services/drugs-health-products/medical-devices/list-licensed-medical-device-establishments.html](https://canada.ca/en/health-canada/services/drugs-health-products/medical-devices/list-licensed-medical-device-establishments.html) 澳大利亚治疗用品管理局 (TGA) 医疗器械注册合作伙伴机构数据库：[https://tga.gov.au/registration-and-certification/device-registration-and-certification/device-registration/appointed-representative](https://tga.gov.au/registration-and-certification/device-registration-and-certification/device-registration/appointed-representative) 日本医药品和医疗器械机构 (PMDA) 医疗器械注册合作伙伴机构列表：[https://pmda.go.jp/english/edpm/registration/index.html](https://pmda.go.jp/english/edpm/registration/index.html) 注意事项： 选择经验丰富、信誉良好的合作伙伴机构至关重要。 确保业务伙伴机构符合相关监管机构的要求。 清楚了解业务伙伴机构的服务范围和费用。 定期沟通并监控注册过程的进展。