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
미국 내 의료기기 및 방사선 방출 제품의 규제를 담당하는 FDA 센터.
유럽경제지역에서 판매되는 의료기기에 필수인 적합성 표시로, EU 보건, 안전 및 환경 요건 준수를 나타냄.
Comisión Federal para la Protección contra Riesgos Sanitarios
멕시코 연방 보건 위험 보호 위원회. 멕시코의 의료기기, 의약품 및 식품 안전 규제를 담당.
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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