Mexico
Surgical sutures are medical devices used in nearly every surgery to close wounds, secure tissues, and promote healing. In Mexico, like in many other countries,
Risk analysis is a cornerstone of medical device safety, ensuring that all the potential hazards are identified, evaluated, and mitigated throughout the device’s lifecycle. In
When seeking sanitary registration for medical devices in Mexico through COFEPRIS, companies have traditionally followed one of two routes: the ordinary process or the fast-track
Mexico’s regulatory landscape has been active, presenting important updates. Previously, we discussed the agreement published on June 11, 2025. However, as that version will soon
In this article, we will explain the implications of the Official Decree published on June 2, 2025, in the Official Mexican Diary and how it
Medical devices that are in contact with human tissues represent a significant risk of infection and cross-contamination if not properly sterilized. Ensuring sterility for single-use,
