This episode focuses on the single most critical challenge for Korean medical device companies entering the Mexican market: the stringent Spanish language requirements mandated by the regulatory authority, COFEPRIS. We explore how this impacts the entire registration process, from technical documentation to labeling, and why overcoming this linguistic barrier is fundamental for successful market access.

Key Questions:

- Why is Spanish proficiency the top regulatory hurdle for Korean device manufacturers in Mexico?

- What are COFEPRIS's specific language rules for technical dossiers and official communications?

- How does the requirement extend beyond documents to product labeling and instructions for use?

- What are the risks of using direct or machine translation for regulatory submissions?

- How can in-country, native-speaking consultants de-risk the market entry process?

- What challenges do Korean SMEs, accustomed to domestic business, face with international documentation?

- How does proper localization differ from simple translation in the eyes of regulators?

Pure Global offers end-to-end solutions for MedTech and IVD companies seeking to navigate complex regulatory landscapes like Mexico's. Our local experts and advanced AI tools streamline global market access, from regulatory strategy and technical dossier preparation to acting as your official in-country representative. We turn regulatory hurdles into strategic advantages, helping you get to market faster. For support with your expansion into Mexico or over 30 other countries, contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.