Japan Equivalency Agreement for Medical Devices in Mexico

In previous articles and guidelines, we have explained the registration process for medical devices in Mexico though the so called ordinary process and equivalency agreements, also known as fast-track processes. This time, we will go deeper into Japan equivalency agreement.   To clearly understand the requirements for the Japan equivalency agreement, first we need to […]

NOM 064 – Official Mexican Standard for in vitro diagnostics

vitro mexico

Unlike other countries, in vitro diagnostics IVDs in Mexico are considered as medical devices and thus subject to general regulations and special rules for its classification and grouping. However, there is a specific standard that IVDs must accomplish in addition to other regulations, and we will explain it briefly in this text.   Background   […]

Retroactive renewals for Medical Devices in Mexico

In recent months, COFEPRIS has been experiencing a series of changes with the aim of attending overdue requests. In this article, we will focus on three fundamental events that are already being  executed leading to a quicker renewal process for sanitary registrations:   In May 2021, the Ministry of Health in Mexico updated the Health […]