Classification and Grouping for Ultrasound systems in Mexico

As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in Appendix II – Supplement of medical devices of the Mexican Pharmacopeia (FEUM).   In this article we will focus on explaining strategies to classify and group […]

What COFEPRIS requires for the Certificate of Free Sale.

The Certificate of Free Sale (CFS), also known as “Certificate for Export” or “Certificate to Foreign Government”, is a document to evidence that goods, such as medical devices, are legally sold or distributed without restriction. Ministries of Health from different countries require a Certificate of Free Sale as part of their regulatory evaluation.   In […]

New amendments in the regulation for Medical Devices in Mexico

Last May the 31st 2021, the Ministry of Health in Mexico released an update to the Health Supplies Regulation. There are several amendments impacting different health supplies and in this document we will present a summary for those affecting Medical Devices:   Translations   Before this announcement, the Ministry of Health required that any submission […]

Software as a Medical Device (USA, Europe, Canada and Mexico cases)

Technological advances in health care have placed software as an essential component of products and services for diagnostic and analysis of clinical conditions and diseases. Even when software has been included as part of medical devices, in recent years it has been an increased use of software as a medical device by its own. This […]

About the regulation of previously owned medical devices in Mexico

The market of previously owned medical devices in Mexico works in different business models and therefore, arises questions about its regulatory requirements. For instance, public hospitals in Mexico are not allowed to buy previously owned medical equipment, but they can accept them by donation. It is also well known that used, refurbished or remanufactured medical […]

Medical devices and e-commerce in Mexico

  COVID-19 pandemic is having an impact in many industries including medical devices and the electronic commerce. In fact, e-commerce has been experiencing a significant growth in the last months boosted by social distancing. Such changes present regulatory opportunities that we will further explore in this text. Specifically, we will take the case of Mexico. […]

Classification of CPAPs (Continuous Positive Air Pressure) devices in Mexico

As mentioned in our Classification and Grouping Ultimate Guide, there are a series of rules to classify and group medical devices. The above-mentioned rules are fully explained in Appendix II – Supplement of medical devices of the Mexican Pharmacopeia (FEUM).     In this article we will focus on explaining strategies to classify and group […]

Requirements for a medical device warehouse in Mexico

One of the requirements to register a medical device in Mexico, is to have a warehouse to store the product. It is true that there are not rules about the extension of the warehouse, but either it is a regular place with few square meters or a big depot, there is a list of requirements […]

New guideline for Covid-19 related supplies in Mexico.

Last March 19th 2021, COFEPRIS published a guideline with rules and requirements related to COVID-19 (SARS-CoV2 virus) supplies in Mexico. Even though the purpose of this guide is to provide formality on regulatory processes and clarify common questions for the industry, we do still find certain gaps for which the users should be cautious.   […]

MDSAP and how to use it in Mexico

MDSAP and its implementation for Sanitary Registration of Medical Devices in Mexico with Equivalency Agreements    Since 2012 the International Medical Device Regulators Forum (IMDRF) has been working in a project called Medical Device Single Audit Program (MDSAP) with the aim of conducting a single regulatory audit of  medical device manufacturers that satisfies the relevant requirements of the regulatory authorities participating in the program. The […]