MFDS to COFEPRIS: Why Your Korean Medical Device Classification is Invalid in Mexico Titelbild

MFDS to COFEPRIS: Why Your Korean Medical Device Classification is Invalid in Mexico

MFDS to COFEPRIS: Why Your Korean Medical Device Classification is Invalid in Mexico

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 This episode details the critical error of applying South Korea's four-tier MFDS medical device classification directly to Mexico's three-tier COFEPRIS registration system. We explain why the differing regulatory frameworks, classification rules, and risk criteria make a direct transfer impossible and discuss the severe consequences of such a mistake, including immediate rejection, costly delays, and reputational damage with the regulatory authority. - Why is it a mistake to use a Korean device classification for a Mexican market submission? - What are the primary differences between the MFDS and COFEPRIS classification systems? - How many risk classes for medical devices exist in South Korea versus Mexico? - What are the consequences of submitting a device to COFEPRIS with the wrong classification? - Can a device's risk level change when moving from the Korean to the Mexican market? - How do different national regulations impact global market access strategy? - What is the first step to ensure a smooth registration process in Mexico? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. Our experts develop efficient regulatory strategies, leveraging a single registration process to access over 30 markets, including Mexico and South Korea. We use advanced AI and data tools to compile technical dossiers, manage submissions, and provide continuous regulatory monitoring, ensuring your products meet local standards from initial strategy to post-market surveillance. Let us handle the complexities of COFEPRIS and MFDS regulations. Visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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