Click here for an overview of the National Standards Bodies of the Americas and their relationship with international Standards Developing Organizations and their medical device technical committees and subcommittees.

Links to National Standards Body Technical Committees for Medical Device Standardization:

Comité – Productos y Tecnologia para el Cuidado de la Salud

United States

The U.S. uses international standards directly from ISO/IECASTM International, and from ANSI accredited Standards Developing Organizations such as AAMICLSI, and MITA which either generally base their standards on those of ISO/IEC or that submit their standards to become ISO/IEC standards – working through and supporting the U.S. mirror committees to ISO and IEC and administering the ISO/IEC committees.

REGULATORY COALITION PRINCIPAL MEMBERS