CMC CONSULTING GROUP is an international group of consulting firms focused on regulatory affairs for medical devices.
Based in Spain, it has established various offices in the United Kingdom, Spain, Switzerland, China, Australia, and the USA. With professional technical teams from various fields around the world, it can provide personalized services for international clients based on the actual conditions of the manufacturer.
News and Updates
COFEPRIS Medical Device Registration in Mexico: A Step-by-Step Guide
Mexico is one of the largest healthcare markets in Latin America. To sell medical devices or in vitro diagnostics (IVDs) in Mexico, foreign manufacturers must secure a Sanitary Registration (Registro Sanitario) from COFEPRIS (Comisión Federal para la Protección contra Riesgos [...]
EU Medical Device Classification: Class I, IIa, IIb & III Explained with Examples
Accurate risk classification forms the foundation of your entire regulatory strategy under the European Medical Device Regulation (EU) 2017/745 (MDR). Specifically, this classification dictates your compliance pathway in the European Union. Consequently, it impacts clinical data requirements and Notified [...]
MDSAP Explained: One Audit for 5 Markets (US, Canada, Brazil, Japan, Australia)
Obtaining regulatory approval in multiple international markets often means dealing with a barrage of redundant Quality Management System (QMS) audits. For manufacturers looking to expand globally, this replication of effort consumes valuable time, capital, and resources. The Medical Device [...]
