Global MedTech Regulation FAQ

Your comprehensive guide to medical device regulations worldwide

We're continuously expanding our FAQ coverage. Currently featuring detailed guides for Brazil and Mexico, with more countries coming soon.

Available FAQ Guides

🇧🇷

Brazil

ANVISA - Brazilian Health Regulatory Agency

9 Guides Available

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

Dec 2022-2026 (phased)

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 Guides Available

NOM-241-SSA1-2012Good Manufacturing Practices for Medical Device Establishments

NOM-137-SSA1-2008Labeling Requirements for Medical Devices

🇨🇳

China

NMPA - National Medical Products Administration

1 Guide Available

NMPA Order No. 47Medical Device Registration and Filing Management Measures

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

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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.