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 […]
Applicable standards for Medical Devices
Medical devices are a broad group of products with different characteristics. Thus, many standards have been developed to establish general and particular specifications for them. In this text, we cover the most relevant international standards that can be found in the medical device industry that are useful for regulatory purposes. ISO 13485 Medical devices […]
Combination products and regulatory approach in Mexico
In general terms, combination products consist in a pharmaceutical product including chemical synthesis molecules, biologic or biotechnological API’s, that are contained in a medical device. Such products are already being regulated in the USA and EU. In Mexico, it can be confusing registering a product combining medicines and medical devices. In this article we will […]
The use of tariff codes in Mexico for medical devices
In general terms, tariff codes are a series of numbers to identify products for international trade purposes. These codes are standardized worldwide by the Harmonized System (HS) established by the World Trade Organization (WTO). Although there might be exceptions, the tariff code is the reference to import goods in different countries. The main use […]
