Technovigilance reports
One of the key activities that any sanitary registration holder in Mexico must perform after obtaining the marketing authorization is the technovigilance. This is mandatory for holders and Medical Device distributors according to the NOM-240-SSA-2012. In our blog, you can find two articles describing the generals of Technovigilance and how to handle notifications. In this […]
Medical Device Advertising for the General Public in Mexico
We have discussed in previous articles about the regulations for advertising medical devices in Mexico and explained the particulars for the ads targeted exclusively to healthcare professionals. In this third article, we will close the topic explaining the details of advertisement directed to the general public. How is it regulated? Advertising medical devices […]
Letters of Authorization
Una Carta de Autorización (LoA), también conocida como Carta de Representación, es un tipo de acuerdo entre dos empresas en el que una autoriza a la otra a realizar determinadas actividades y obtener responsabilidades en nombre de la primera empresa. En este artículo explicaremos el uso de las LoA para la industria de Dispositivos Médicos […]
Technovigilance notifications
The legal framework for medical devices in Mexico involves several responsibilities for the Mexican Registration Holders (MRH), including compliance with local standards known as Mexican Official Norms (NOM). In fact, one of the applicable NOMs is the NOM-240-SSA-2012 in relation to the Establishment and Operation of Technovigilance Programs in the country. This NOM is the […]
Medical Device advertisement in Mexico for Healthcare Professionals
Advertisement is the main way to promote products, including medical devices. However, in Mexico, there are rules for advertising medical devices intended or operated by Healthcare professionals. In this article, we describe the most common types of ads in the medical device industry and how they are regulated in Mexico. As discussed in our […]
The Medical Device Market in Mexico 2021
Introduction Following our last Medical Device Market report for the Mexican Market in 2020, we present our report with the latest information we got from 2021. In this article we will talk about the importation/exportation value in Mexico compared to other countries. We also add some facts about the healthcare system and the […]
Alternatives to register in Mexico a Medical Device with no Certificate of Free Sales.
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 of origin approves the device. In this article, we explore some cases when the product is not sold or approved in its country of origin and alternatives to register it […]
Duplicate Medical Device Registrations in Mexico
Background Obtaining a Sanitary Registration for a medical device in Mexico is a complex process that may take from months up to years. Thus, once obtained, it is very important to maintain those authorizations valid. Specifically, being aware of when to renew them, when to request an amendment through an administrative or technical modification […]
The Medical Device Manufacturer definition (The Mexico case)
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 chains tend to be complex, considering that more than one company can be involved in the process. Such elaborated network raises questions of who is the main manufacturer and how […]
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 […]
