全球医疗器械法规常见问题
您的全球医疗器械法规综合指南
我们正在不断扩大常见问题的覆盖范围。目前提供巴西和墨西哥的详细指南，更多国家即将推出。
可用的常见问题指南
🇧🇷
Brazil
ANVISA - Brazilian Health Regulatory Agency
9 指南 可用
RDC 925/2024Medical Device Sanitary Control & Import Procedures
RDC 848/2024Medical Device Regularization & Compliance
RDC 830/2023In Vitro Diagnostic (IVD) Medical Devices
RDC 751/2022Medical Device Risk Classification & Registration
RDC 657/2022Software as Medical Device (SaMD) Regulation
RDC 591/2021Unique Device Identification (UDI) System
RDC 687/2022GMP Certification for Medical Device Manufacturers
RDC 665/2022Good Manufacturing Practices for Medical Devices
RDC 40/2015Medical Device Notification Requirements
🇲🇽
Mexico
COFEPRIS - Federal Commission for Protection against Health Risks
2 指南 可用
🇨🇳
China
NMPA - National Medical Products Administration
1 指南 可用
即将推出
🇺🇸
United States
FDA
• 21 CFR Part 820 - Quality System Regulation
• 510(k) Premarket Notification
• PMA - Premarket Approval
🇪🇺
European Union
European Commission
• MDR 2017/745 - Medical Device Regulation
• IVDR 2017/746 - In Vitro Diagnostic Regulation
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注意： 这些常见问题指南提供有关法规要求的一般信息，不应被视为法律建议。法规可能会发生变化。请始终咨询合格的法规专业人士，以获取有关医疗器械提交的具体指导。