Mexico Medical Device Updates 2025: COFEPRIS Reforms You Need to Know
Mexico’s health regulatory authority, COFEPRIS (Federal Commission for Protection against Sanitary Risks), has recently introduced significant reforms to modernize the medical device regulatory landscape. These changes aim to streamline processes, align with international standards, and improve market access for medical device manufacturers.
Here are 6 of the most important updates:
1. Unified Registration Process
As of August 2025, COFEPRIS consolidated multiple submission categories for new registrations and renewals into a single, streamlined procedure. This reform significantly shortens review timelines and simplifies submissions. Note, however, that fast-track registration routes based on prior approvals from the USA, Canada, and Japan were removed.
2. Recognition of International Approvals
COFEPRIS now acknowledges certifications and evaluations from recognized regulatory authorities (RRAs) and the WHO Drug Prequalification Program. This recognition reduces the complexity and duration of the registration process, allowing international manufacturers to enter the Mexican market more efficiently.
3. Expanded Equivalence Pathway
Previously limited to the USA, Canada, and Japan, the equivalence pathway now includes Australia, Brazil, China, EU, Russia, Singapore, South Korea, Switzerland, the UK, and the USA. Devices approved in these countries can benefit from a faster registration process in Mexico.
4. Overhaul of Low-Risk Device List
For the first time in over a decade, COFEPRIS updated its list of low-risk medical devices. Devices are now categorized into three annexes, each with specific regulatory requirements, simplifying the commercialization process for manufacturers and importers.
5. New Good Manufacturing Practices (GMP) Standard
The new NOM-241-SSA1-2025, effective April 2025, replaces the previous GMP standard. Key changes include:
- Removal of the chapter on device classification.
- Consolidation of sample retention requirements into a single section.
- Alignment with the Mexican Pharmacopoeia for device classification rules.
6. Draft Technovigilance Standard
COFEPRIS released a draft Medical Device Technovigilance Standard (PROY-NOM-240-SSA1-2024) in July 2024. This draft expands definitions, includes more stakeholders in the National Technovigilance System, and clarifies requirements for device deficiencies, trend reporting, and quality management systems. Public comments were open until September 29, 2024.
Conclusion
These reforms demonstrate COFEPRIS’s commitment to modernizing Mexico’s medical device regulation, making it more efficient, transparent, and internationally aligned. Manufacturers and importers should review these changes carefully to ensure compliance and take advantage of the streamlined processes.