Medical Device/IVD CFDA Registration & Approval
医疗器械/IVD注册服务
- Medical device/IVD registration and regulatory compliance
- 医疗器械/IVD注册
- SDA (CFDA) certificate composition strategy
- 制定注册策略
- Technical dossier preparation and on-site type testing support
- 提供技术文件及检测支持
- Software and cybersecurity document complied to meeting SDA(CFDA) requirement
- 协助编写符合药监局要求的软件及网络安全文件
- SDA (CFDA) application submission and communication with reviewers
- 提交注册申请、协助与审评员沟通
- Registration inspection coordination
- 协调注册审评
- SDA (CFDA) certification renewal and modification
- 医疗器械注册证续证及变更
- Translation & Sample Importation Logistics
- 翻译及样品进口