Mexico
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,
Obtaining a sanitary registration in Mexico is mandatory for marketing a medical device in the country. Typically, each device requires its own registration based on
Manufacturers seeking to commercialize their medical devices in Canada must obtain a Medical Device Licence (MDL) from Health Canada (HC). Meanwhile, in Mexico, medical devices
