Mexico
As previously discussed in our article for Software as a Medical Device (SaMD), a significant development has occurred in the Mexican regulatory framework. The introduction
In Mexico, when registering medical devices related to Ionized Radiation Sources, there is a special subset of documents to be presented. The Authorization for the
As mentioned in our article about the Equivalency Agreement and our Ultimate Guide for Regulatory Affairs in Mexico, one of the choices you have to
In a previous article, we have reviewed the regulations for medical electrical equipment (MEE) in Mexico and mentioned the cases when a medical electrical equipment
When registering Medical Devices in Mexico, the classification and grouping strategy is a key activity for optimizing the number of registrations (based on 23 rules).
In our Classification and Grouping Ultimate Guide, we have explained how to classify and group medical devices according to the 23 rules detailed in the Appendix
