COFEPRIS, the Mexican regulatory authority, in May 2024 officially announced the approval of the first software as a SaMDmedical device, authorised through an equivalence procedure and in compliance with the requirements of the Regulation for Software as a Medical Device known as Appendix X of the 5.0 edition of the Supplement of Medical Devices of Pharmacopoeia (July 10, 2023).
High-tech software for the treatment of myocardial infarction is an innovative device that is being authorised in Mexico for the first time. The device consists of an interactive screen that receives, processes and transmits aortic and distal pressure signals in real-time, allowing healthcare professionals to customise treatments for effective care.
The second authorised device, which can be used in a smartwatch, is intended for patients diagnosed with atrial fibrillation, to signal irregularities in heart rhythm. The instrument allows patients to receive real-time information on their heart rate and enables early identification of irregularities in heart rhythm.
Equivalence paths
The two software were approved through equivalence agreements with the US Food and Drug Administration (FDA).
In the wake of the process of global harmonisation of regulations on Medical Devices, the Regulatory Authority of Mexico recognises and authorises with shortened procedures the entry of devices that have previous approval from regulatory authorities in other countries of the world, specifically: the United States, Canada, and Japan.
Regulation of Software as a Medical Device in Mexico
Software as a SaMD medical device found a new definition in July 2023, in Appendix X above.
Whereas software was previously considered essentially as an accessory of a hardware device, in the new definition it is described more broadly and is suitable for the latest generation of devices.
According to this definition, the device can be used for one or more medical purposes, without the need to be part of the hardware to fulfil the intended medical purpose. It can run on generic computer platforms and can be used alone and/or in combination with other products. Mobile applications that meet this definition are considered software as a medical device. The software that powers the physical medical device is to be considered excluded from this definition.
Software as a Medical Device (SaMD) is classifiable according to risk Class I, II, or III; the classification criteria are set out in Rule 16 of Appendix II of the 5.0 Edition Supplement of Medical Devices of the Pharmacopoeia.
Revisions in the classification rules for Medical Devices in Mexico are expected and updates will follow.
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Source:
Comisión Federal para la Protección contra Riesgos Sanitarios | Gobierno | gob.mx (www.gob.mx)