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Listen "Pure Global Presents LATAM MedTech Insights: Mastering Mexico's NOM-241 GMP for Medical Device Manufacturing Success"
Episode Synopsis
This episode of LATAM MedTech Insights provides a detailed analysis of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. We explore the critical requirements for medical device manufacturers, importers, and distributors operating in Mexico, focusing on the pillars of a compliant Quality Management System (QMS), risk management, and supply chain control.
We break down what COFEPRIS, Mexico's health authority, looks for during an audit and why simply being ISO 13485 certified is not enough. This episode is essential for any MedTech company looking to leverage Mexico's manufacturing advantages and access one of the largest markets in Latin America. We also look ahead to the upcoming changes with the 2025 version of the standard, helping you stay ahead of the regulatory curve.
Consider this real-world scenario: a U.S. MedTech scale-up invests millions in a state-of-the-art manufacturing facility in Jalisco, aiming to supply the entire LATAM region. However, their market launch is halted after a COFEPRIS audit. The reason? Their risk management files were deemed static, and their supplier validation for a critical component sourced from Asia lacked the specific traceability data required by NOM-241, jeopardizing their entire investment and market-entry strategy.
What You'll Learn:
1. Why is NOM-241 a mandatory gateway to the Mexican market and not just a guideline?
2. What are the core pillars of a Quality Management System that COFEPRIS auditors scrutinize?
3. How does NOM-241's approach to technovigilance impact the entire product lifecycle?
4. What are the most common documentation gaps that lead to GMP compliance failures in Mexico?
5. Are your supplier qualification processes robust enough for the standard's strict requirements?
6. How can you prepare your facility for the upcoming changes in the 2025 version of NOM-241?
7. Why might your existing quality certifications be insufficient for gaining approval in Mexico?
8. What specific risk management activities must be continuously updated to maintain compliance?
Navigating complex local regulations like NOM-241 is critical for success. At Pure Global, we offer end-to-end regulatory consulting for MedTech companies, combining deep local expertise in over 30 markets with advanced AI tools to streamline your global market access. From initial regulatory strategy to acting as your local representative, we ensure your path to compliance is clear and efficient. Don't let regulatory hurdles block your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.
We break down what COFEPRIS, Mexico's health authority, looks for during an audit and why simply being ISO 13485 certified is not enough. This episode is essential for any MedTech company looking to leverage Mexico's manufacturing advantages and access one of the largest markets in Latin America. We also look ahead to the upcoming changes with the 2025 version of the standard, helping you stay ahead of the regulatory curve.
Consider this real-world scenario: a U.S. MedTech scale-up invests millions in a state-of-the-art manufacturing facility in Jalisco, aiming to supply the entire LATAM region. However, their market launch is halted after a COFEPRIS audit. The reason? Their risk management files were deemed static, and their supplier validation for a critical component sourced from Asia lacked the specific traceability data required by NOM-241, jeopardizing their entire investment and market-entry strategy.
What You'll Learn:
1. Why is NOM-241 a mandatory gateway to the Mexican market and not just a guideline?
2. What are the core pillars of a Quality Management System that COFEPRIS auditors scrutinize?
3. How does NOM-241's approach to technovigilance impact the entire product lifecycle?
4. What are the most common documentation gaps that lead to GMP compliance failures in Mexico?
5. Are your supplier qualification processes robust enough for the standard's strict requirements?
6. How can you prepare your facility for the upcoming changes in the 2025 version of NOM-241?
7. Why might your existing quality certifications be insufficient for gaining approval in Mexico?
8. What specific risk management activities must be continuously updated to maintain compliance?
Navigating complex local regulations like NOM-241 is critical for success. At Pure Global, we offer end-to-end regulatory consulting for MedTech companies, combining deep local expertise in over 30 markets with advanced AI tools to streamline your global market access. From initial regulatory strategy to acting as your local representative, we ensure your path to compliance is clear and efficient. Don't let regulatory hurdles block your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.
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