Mexico’s Ministry of Health Makes Progress with SaMD

By Pedro Omar Sánchez Neri

The regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD). Software was included officially in the definition of medical devices and rule 16 was added to Appendix II to classify software according to risk (Class I, II, or III). In addition, there was the new Appendix X specifically on software. These requirements became official on July 10, 2023.

Edition 5.0 of Pharmacopoeia, Software and Equivalency

Besides the long-standing standard submission route, there is a system in Mexico with COFEPRIS to leverage other regulatory authorizations referred to as the equivalency route. A previous regulatory authorization with the U.S. FDA, Health Canada, and Japan MHLW, can be leveraged in Mexico. This reduces the number of documents that must be submitted and expedites the COFEPRIS review time.

SaMD authorizations in May 2024

The press releases (Communication 70/2024 and 72/2024 (links in Spanish)) confirmed that COFEPRIS announced its first and second approvals for SaMDs, both issued under the FDA equivalency route. The first registration is for a SaMD which would display and process data about aortic and distal blood pressure signals. The second registration was issued for a cardiac monitoring software app in smartwatches.

Access to these devices by medical professionals and layperson users in Mexico would improve the cardiac data provided to patients.

Concluding remarks

We at Emergo by UL share the excitement of the Ministry of Health in Mexico. This is undoubtedly a significant milestone, and we hope to see the number of SaMD approvals with COFEPRIS increase steadily.