On May 10, the Official Gazette of the Federation published the Notice regarding the release of Supplement for Medical Devices 5.0 of the Mexican Pharmacopeia (FEUM).
Among the updates in this new edition is the inclusion of new appendices, including the regulatory appendix concerning Software as a Medical Device (SaMD). In this article, we explore the key aspects of this new regulation, as well as the requirements for compliance.
The objective of Appendix X: Software as a Medical Device is to establish harmonized definitions and both general and specific considerations throughout the SaMD life cycle. It also aims to create a shared understanding of clinical evaluation and the principles for demonstrating the safety and performance of these devices.
The inclusion of this appendix provides clarity and regulatory structure to an area that previously lacked specific regulations. For years, medical-purpose software was marketed in Mexico without sanitary regulation. However, with this new edition of the Supplement, the obligation to obtain sanitary registration for such devices is now formally recognized, in accordance with the requirements outlined in the Procedures and Services Agreement and Appendix III of the FEUM.
The sanitary registration process for Software as a Medical Device involves compliance with both administrative-legal and technical requirements.
It is important to note that Appendix X also addresses the regulatory approach for mobile applications considered Software as a Medical Device. These mobile apps are subject to sanitary control and must meet the requirements established in Appendix X and other applicable regulatory instruments.
The publication of the Medical Devices Supplement 5.0 of the FEUM and the incorporation of Appendix X on Software as a Medical Device represent a significant step forward in the regulation of medical devices in Mexico. This new regulation sets out clear definitions, life cycle considerations for SaMD, principles for clinical evaluation, and requirements for sanitary registration.
Discover all the specifications and requirements for medical device regulation in Mexico in our e-book at the link below.