Medical Device Regulatory Glossary
Comprehensive definitions for medical device regulatory terminology. Learn what FDA 510(k), CE Marking, EU MDR, ANVISA, NMPA, and other regulatory terms mean.
What is a medical device regulatory glossary?
A medical device regulatory glossary is a reference guide that defines terminology used in the medical device industry. It covers regulatory authorities (FDA, ANVISA, NMPA), submission types (510(k), PMA, De Novo), compliance standards (CE Marking, GMP, ISO 13485), and market access requirements across global markets.
Center for Devices and Radiological Health
El centro de la FDA responsable de regular dispositivos médicos y productos que emiten radiación en los Estados Unidos.
Un marcado de conformidad obligatorio para dispositivos médicos vendidos en el Espacio Económico Europeo, que indica el cumplimiento de los requisitos de salud, seguridad y medio ambiente de la UE.
Comisión Federal para la Protección contra Riesgos Sanitarios
La Comisión Federal para la Protección contra Riesgos Sanitarios de México, responsable de regular dispositivos médicos, medicamentos y seguridad alimentaria en México.
Una vía regulatoria de la FDA para dispositivos médicos novedosos de riesgo bajo a moderado que no tienen un dispositivo predicado para comparación 510(k).
Design History File
Una compilación de registros que describen el historial de diseño de un dispositivo médico terminado, requerido por la FDA bajo 21 CFR Parte 820.
European Authorized Representative
Una entidad legal establecida en la Unión Europea designada por un fabricante no comunitario para actuar en su nombre en asuntos regulatorios bajo el MDR de la UE.
European Union Medical Device Regulation
El Reglamento de Dispositivos Médicos de la Unión Europea (2017/745) que rige la aprobación, fabricación y vigilancia poscomercialización de dispositivos médicos en la UE.
The international standard for quality management systems specific to medical device organizations.
In Vitro Diagnostic
Un dispositivo médico utilizado para examinar muestras del cuerpo humano para proporcionar información con fines de diagnóstico, monitoreo o detección.
National Medical Products Administration
China's national regulatory authority for drugs, medical devices, and cosmetics, formerly known as CFDA.
An organization designated by an EU Member State to assess the conformity of medical devices before they are placed on the market.
Premarket Approval
The FDA's most rigorous device marketing pathway, required for high-risk Class III medical devices to demonstrate safety and effectiveness.
Pharmaceuticals and Medical Devices Agency
Japan's regulatory agency responsible for ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices.
About This Medical Device Regulatory Glossary
This glossary provides clear, accurate definitions of medical device regulatory terminology used by regulatory affairs professionals, quality managers, and industry stakeholders worldwide. Whether you're navigating FDA submissions, EU MDR compliance, or expanding into markets like Brazil, China, or Japan, understanding regulatory terminology is essential for success.
Key Topics Covered
Regulatory Authorities
FDA, ANVISA, NMPA, PMDA, COFEPRIS, and more
Global Market Access
CE Marking, 510(k), PMA, registration pathways
This resource is part of Pure Global's "FREE AI for Global Good" initiative, providing free regulatory intelligence to help medical device companies bring life-saving technologies to patients worldwide.
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