The objective of this guide is to establish the essential requirements that Class I, II, and III Medical Devices (MD) and Software as a Medical Device (SaMD) must meet to obtain registration and facilitate the integration of information in the dossier.
Update
The guide for obtaining the Sanitary Registration of Medical Devices, published on December 12, 2023, optimizes the requirements of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS, in Spanish). To comply with the registration process it ensures compliance with health regulations in Mexico, strengthening the process's integrity to ensure MD's safety and quality in the market.
In addition to outlining the general requirements for the Sanitary Registration of Class I, II, and III MD, this guide incorporates the criteria for registering SaMD to demonstrate their safety and efficacy. Furthermore, it elaborates on additional requirements for devices involving sensors and mobile applications on smart devices. In accordance with regulations, the guide provides links to valuable resources to enhance the efficiency of the sanitary registration process.
Regulatory framework
The “Guide for Obtaining Sanitary Registration of Medical Devices” establishes essential requirements to obtain Sanitary Registrations per the updated Regulation of Health Products (RIS, in Spanish) as of 2021. Where it defines the necessary criteria for obtaining the registration, it also considers the appendices of the Pharmacopoeia of the United Mexican States (FEUM, in Spanish) 5.0 and continues to take into account Article 262 of the General Health Law (LGS, in Spanish), which categorizes medical devices in Mexico based on their function, and includes SaMD according to Appendix X of the FEUM 5.0.
Effects from the RA update
The guide is essential for any individual or legal entity seeking to market medical products in Mexico. It provides a fundamental tool to facilitate regulatory compliance, streamline the sanitary registration process, and ensure adherence to local regulations. This document is issued in response to the Regulatory Certainty Strategy for MD established by COFEPRIS.
Written By:
Ana Carla Díaz
About ips
Our regulatory affairs team helps medical device manufacturers obtain the necessary sanitary licenses to commercialize their products in Mexico. We have a deep understanding of the local regulatory framework and a proven track record of success. We offer a wide range of services to meet your specific needs. Contact your service leader or email us at info@insumosparasalud.com to learn more.