New expedited timelines for Medical Device Registration approvals in Mexico

Introduction   Last November the 18th 2020, the Ministry of Health in Mexico released a note through the Official Diary establishing new expedited timelines for medical devices and pharmaceutical supplies registration approvals. This is not the first time the government tries to improve the official time responses. Nevertheless, different circumstances as the international UNOPS bid […]

Equivalency Agreement summary

mexican fda

  Every controlled medical devices intended to be sold in Mexico must undergo a previous authorization by the Mexican Ministry of Health before its commercialization. The aforementioned authorization is a document called Sanitary Registration, which COFEPRIS (the Mexican FDA) issues after evaluating a set of requirements. In addition, there are two ways to obtain the […]