Mexico
Requirements to obtain a Medical Device Sanitary Registration in Mexico are well established. However, such requirements imply that the Ministry of Health from the country
Background Obtaining a Sanitary Registration for a medical device in Mexico is a complex process that may take from months up to years. Thus,
In general terms, a manufacturer is defined as a company who makes products. In some industries, such as in the medical device one, the supply
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,
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
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
