Global MedTech Regulation FAQ
Your comprehensive guide to medical device regulations worldwide
Available FAQ Guides
Brazil
ANVISA - Brazilian Health Regulatory Agency
RDC 751/2022
-Medical Device Risk Classification & RegistrationRDC 830/2023
-In Vitro Diagnostic (IVD) Medical DevicesRDC 848/2024
-Medical Device Regularization & ComplianceRDC 925/2024
-Medical Device Sanitary Control & Import ProceduresRDC 591/2021
-Unique Device Identification (UDI) SystemRDC 657/2022
-Software as Medical Device (SaMD) RegulationComing Soon: RDC 665/2022 - Good Manufacturing Practices
Coming Soon
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
China
NMPA
• Medical Device Classification Rules
• Registration and Filing Management
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Note: These FAQ guides provide general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance on your medical device submissions.