During the first half of 2026, COFEPRIS refined several technical criteria that directly affect the health registration of medical devices. For registration holders, anticipating these adjustments is key to avoiding objections and delays.
What changes in practice
The most relevant points concern risk classification and the clinical evidence that supports the safety and performance of the product. The authority aims to align dossiers with international best practices.
- Greater detail in justifying the assigned risk class.
- Clinical evidence proportional to the device's risk.
- Emphasis on traceability of the manufacturer's technical information.
Recommendations for holders
Proactively reviewing current dossiers helps identify gaps before any renewal or amendment. At Inteligencia Sanitaria we support this analysis while holding the regulatory title independently, without intervening in your commercial strategy.
A well-supported dossier today prevents costly objections tomorrow.
If your company plans to register or renew medical devices in Mexico, it is worth mapping these requirements early. We will keep publishing updates as the authority releases new guidelines.