Medical Device/IVD CFDA Registration & Approval
醫療器械/IVD注冊服務
- Medical device/IVD registration and regulatory compliance
- 醫療器械/IVD注冊
- SDA (CFDA) certificate composition strategy
- 制定注冊策略
- Technical dossier preparation and on-site type testing support
- 提供技術文件及檢測支持
- Software and cybersecurity document complied to meeting SDA(CFDA) requirement
- 協助編寫符合藥監局要求的軟件及網絡安全文件
- SDA (CFDA) application submission and communication with reviewers
- 提交注冊申請、協助與審評員溝通
- Registration inspection coordination
- 協調注冊審評
- SDA (CFDA) certification renewal and modification
- 醫療器械注冊證續證及變更
- Translation & Sample Importation Logistics
- 翻譯及樣品進口
