Life Sciences Horizons Brochure 2025 - Flipbook - Page 19
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2025 Horizons Life Sciences and Health Care
Fostering innovation through emerging regulatory trends in Mexico
The digital revolution has spurred remarkable
innovation in health care, with software applications,
platforms, and programs transforming how diseases
are diagnosed, monitored, and treated. As the health
care technology sector experiences unprecedented
transformation, Mexico is positioning itself at the
forefront of a regulatory revolution that promises
to reshape medical device development and
deployment. The regulatory landscape is evolving
to meet the demands of this new era, emphasizing
innovation while safeguarding patient safety. This
balance is crucial as the country aims to become a
leader in the development and adoption of digital
health solutions, mainly within the medical device
and R&D sector.
One of the most significant regulatory advances in recent years
was the 2021 update to NOM-241-SSA1-2012, which governs
Good Manufacturing Practices for Medical Devices. This revision
formally introduced the concept of software as a medical device
(SaMD), setting a precedent for how digital tools designed for
diagnostics, therapy, or monitoring should be regulated.
The publication of Supplement 5.0 of the United Mexican
States Pharmacopoeia for Medical Devices in May 2023 further
underscores Mexico’s commitment to innovation. This
supplement introduced a detailed framework for classifying and
regulating medical software based on risk levels, providing clear
guidance for developers. By incorporating standards for design,
manufacturing, and quality control, Mexico has created a
foundation for fostering innovative solutions while maintaining
high safety standards. It ensures compliance but also encourages
innovation by seeking to reduce uncertainty for technology
developers and investors.
In addition to these regulatory milestones, regulators in
Mexico are actively exploring mechanisms to evaluate advanced
technology, focusing on algorithm performance, bias mitigation,
and mechanisms for protecting patient data while enabling
technological advancement and integration with existing health
care systems. By addressing these factors, Mexico aims to build
a robust ecosystem where cutting-edge technologies can thrive.
Moreover, the Comisión Federal para la Protección contra Riesgos
Sanitarios (COFEPRIS) is embracing digital transformation within
its own processes, implementing e platforms for accelerated
approval mechanisms, streamlined documentation processes,
and real time monitoring. These tools streamline regulatory
procedures, enabling innovators to launch their products more
efficiently while ensuring continuous oversight through a
collaborative innovation platform.
Mexico is not just adapting to the digital health revolution:
it's actively shaping it. For forward-thinking medical device
manufacturers, researchers, and innovators, this represents an
opportunity to redefine health care delivery. Collaboration among
industry stakeholders and policymakers will be essential to
overcome these barriers and fully realize the potential of digital
health innovation in Mexico.
Cecilia Stahlhut
Espinosa
Partner
Mexico City
Paola Neri Rivera
Junior Associate
Mexico City
