THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
COFEPRIS changes affecting medical device submissions
Mexico’s regulatory environment for medical devices is undergoing major transformation. From the new equivalency route and changes in approval modifications to evolving expectations from COFEPRIS—manufacturers must act to stay compliant and competitive. Watch this webinar for a comprehensive breakdown of key changes affecting medical device submissions and market access in 2026.
Webinar date
Feb. 26, 2026
Speaker
Pedro Sánchez Neri, Consulting Manager for Mexico, Peru, and Costa Rica at Emergo by UL
What you’ll learn
During this one-hour webinar, Pedro covers:
The new equivalency route for regulatory reference authorities
- What’s changed since the 2025 agreement
- Updated requirements and documentation differences
- How the regulation interprets and applies RRA reliance
Immediate approval modifications
- Which changes qualify
- Updated processes and timelines
- What the new format means for manufacturers
Additional regulatory shifts impacting 2026 strategy
- NOM 241-SSA1-2025 (new GMP standard)
- Mexican Pharmacopoeia updates, including SaMD changes
- What to expect from COFEPRIS under new leadership
How Emergo by UL can support your strategy
- Classification assessments
- Plan your market approach strategy
- Registration compilation, submission and post approval support
- Training and ongoing regulatory guidance
Who should watch?
If Mexico is part of your commercial or regulatory strategy, this session is essential.
This webinar is ideal for:
- Regulatory affairs professionals
- Quality and compliance leaders
- Manufacturers entering or expanding in Mexico
- Global RA/QA teams managing LATAM portfolios
About the presenter
Pedro Sánchez Neri, Consulting Manager, Mexico, Peru, & Costa Rica, Emergo by UL
Pedro has over 10 years of experience specializing in Mexican medical device regulation. His background includes supporting Fortune 500 companies, delivering on site NOM 241 and NOM 137 training, auditing, conducting more than 100 successful registration submissions, and reviewing complex regulatory strategies across LATAM. He leads Emergo’s consulting services in Mexico, Peru, and Costa Rica, supporting medical device manufacturers with classification, grouping, registration, modifications, renewals, and compliance guidance.
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