Saturday, June 22, 2024

COFEPRIS Incorporates Medical Devices Regulations in New Pharmacopoeia Edition

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The Mexican regulator, COFEPRIS, released the 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (Pharmacopoeia), incorporating regulatory requirements for Software as a Medical Device (SaMD). This marks a significant development in the regulation of medical technology in Mexico. Software is now officially recognized as a medical devices, and rule 16 has been added to Appendix II to classify software according to its risk category (Class I, II, or III). Furthermore, a new Appendix X specifically addresses software-related requirements, providing a detailed framework for developers and manufacturers. These regulatory requirements became official on July 10, 2023, setting a new standard for SaMD in the country.

The latest edition of the Pharmacopoeia not only includes comprehensive definitions and classifications but also introduces the equivalency route, which is a significant advancement in regulatory processes. This route allows COFEPRIS to leverage existing regulatory authorizations from established agencies such as the U.S. Food and Drug Administration (FDA), Health Canada, and Japan MHLW. By acknowledging these prior authorizations, the equivalency route reduces the number of documents that must be submitted, thus streamlining the process and significantly expediting the COFEPRIS review time. This initiative is designed to make it easier and faster for innovative medical software to enter the Mexican market, ensuring that patients and healthcare providers have timely access to the latest technological advancements.

Medical Devices

COFEPRIS Approves First Software as A Medical Devices via FDA Equivalency Route

In May 2024, COFEPRIS marked a milestone by announcing its first two Software as a Medical Devices approvals through press releases (Communication 70/2024 and 72/2024). These medical devices approvals were both granted under the FDA equivalency route, demonstrating the effectiveness of this streamlined process. The first approved SaMD is a software that processes and displays data on aortic and distal blood pressure signals, which is crucial for cardiovascular health monitoring.

The second approval was for a cardiac monitoring software app designed to be used with smartwatches. This app provides continuous cardiac monitoring, which is beneficial for both medical professionals and layperson users in Mexico. The introduction of these devices into the market represents a significant improvement in the availability of advanced cardiac data, which can enhance patient care and outcomes.


Resource: Emergo by UL, June 06, 2024

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