Changes on the Renewal Process for Medical Device Sanitary Registrations in Mexico
As a means to make regulatory processes more accessible and efficient to everyone in the medical device sector in Mexico, COFEPRIS started an upgrading strategy to turn to the digital approach when trying to submit information pertaining regulatory affairs. Thanks to this digitalization process, many of the old regulatory paths regarding the acquisition and upkeep […]
Low-Risk Medical Devices Requirements for Mexico
Obtaining the Sanitary Registration for a product in Mexico requires to consider different regulatory pathways. In knowledge of this circumstances, COFEPRIS made a distinction between products already widely recognized and sold in the market, giving that selection of products the title of Class I Low-Risk, as to reduce the regulatory hurdles in order to obtain […]
Explanatory letters for COFEPRIS
COFEPRIS provides a list of diverse requirements for Medical Devices that must be completed to obtain a sanitary registration in Mexico. Nevertheless, it is often hard for foreign manufacturers to fully comply with all of them. Some of the most common cases are: Documentation not elaborated by the manufacturer COFEPRIS requirements are specific for […]
Label and registration designs
There are specific requirements for obtaining sanitary registrations of Medical Devices in Mexico. Those requirements can be found in the COFEPRIS website, in the National Catalog of Regulations, Procedures and Services and also in our checklist website. In a previous article, we have explained the generals of labeling requirements for medical devices in Mexico, […]
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 […]
