Software as a Medical Device (SaMD) Progress in Mexico

This blog was originally posted on 14th August, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY FERNANDA PARO, REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Introduction

In 2023, the Mexican Federal Commission for the Protection against Health Risks (COFEPRIS) released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia¹ to insert regulatory requirements for Software as a Medical Device (SaMD)² which has enabled the advancement of new products and their launch in the market.

In this blog, we look at the revisions in this new edition.

What’s New in Edition 5.0?

This latest edition was released by the Mexican Ministry of Health after a revision of the legislation following inputs from both academics and the medical device industry and involves one of the most notable revisions which is the expansion of the definition of a medical device to include Software as a Medical Device (SaMD).

The updated definition of a medical device now reads:

“Medical device: Any instrument, apparatus, utensil, machine, software, implantable product or material, diagnostic agent, material, substance, or similar product intended for use, alone or in combination, directly or indirectly in humans, with any of the following intended uses:”

SaMD is specifically defined as:

“Software used for one or more medical purposes, which does not need to be integrated with the hardware of the medical device to achieve its intended medical purpose. It can operate on general computing platforms and may be used alone or in combination with other products (e.g., as a module, other medical devices, etc.). Mobile applications meeting this definition are considered software as a medical device. Software that powers the physical medical device is excluded from this definition.”

It is important to highlight that the new definition of “Medical Devices” now explicitly incorporates software as a standalone medical device. Rule 16 was added to Annex II of the Pharmacopoeia to classify software according to risk. Previously, software was categorized as an accessory to medical equipment and was under the “Low Risk and Deregulated Devices” classification, as per the Agreement on Low Risk and Deregulated Devices dated on 22 December 2014. Also, Annex X was added specifically on software.

Edition 5.0 also includes revisions of classification rules, other definitions and the introduction of new regulatory mechanisms tailored to different device categories. In addition, it contains measures that affect the registration process for low-risk devices, reclassification and a comprehensive section focused on risk management.

Furthermore, Mexico has implemented a regulatory equivalence route, allowing prior regulatory approvals from the U.S. FDA, Health Canada, and Japan’s MHLW to be recognized in Mexico. This approach reduces the number of documents required and expedites the review process by COFEPRIS.

After approval by the US Food and Drug Administration (FDA), Notices Nos. 70/2024 and 72/2024 announced that COFEPRIS approved two SaMDs. The first approval was for a SaMD that displays and processes data related to aortic and distal blood pressure signals, and the second one was for a cardiac monitoring software application for smartwatches. 

SaMD has been regulated since 10 July 2023, the effective date of the Supplement of Medical Devices 5.0. After approval of the 2024 Notices, we reached a significant milestone which facilitates access to such devices for both healthcare professionals and other users, with the aim of improving access to cardiac data. However, even though the Supplement of Medical Devices update addresses registration requirements in Annexes III and IV of the Pharmacopoeia, it does not provide specific details on the registration requirements for SaMD. Manufacturers should pay close attention to further guidance, regulations, and notices that COFEPRIS will issue soon.

Footnotes

1. “The document issued by the Secretariat that outlines the general methods of analysis and the requirements concerning the identity, purity, and quality of drugs, additives, medications, biological products, and other health-related supplies.” ↩︎
2. https://www.dof.gob.mx/nota_detalle.php?codigo=5688295&fecha=10/05/2023#gsc.tab=0 ↩︎

References

1. Mexican Standard NOM-241-SSA1-2021, Good manufacturing practices for medical devices of 20.12.2021
2. Concepts Related To Medical Devices
3. Notice concerning the sale of the Medical Device Supplement 5.0 to the Pharmacopoeia of the United Mexican States of 10.05.2023
4. Agreement announcing the list of health inputs considered as low risk for the purposes of obtaining the Health Registration, and of those products which, due to their nature, characteristics and use, are not considered as health inputs and therefore do not require Health Registration of 22.12.2014
5. Notice No. 70/2024
6. Notice No. 72/2024

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