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 CPAP’s […]
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. Although there are no rules regarding the exact size of the warehouse, whether it is a small space with a few square meters or a large depot, there is a defined list of requirements that must be implemented by […]
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 […]
Technovigilance for Medical Devices in Mexico
Technovigilance, or Medical Device Surveillance, is the activity that ensures that any medical technology in Mexico is correctly working and describes how to report any incident related to the device. In this article, we summarize the technovigilance requirements in Mexico, including: How to identify an adverse incident When to report and when not to report an incident Responsible entities and reporting timelines Recent […]
New expedited timelines for Medical Device Registration approvals in Mexico
Introduction Last November the 18th 2020, the Ministry of Health in Mexico released a note through the Official Diary establishing new expedited timelines for medical devices and pharmaceutical supplies registration approvals. This is not the first time the government tries to improve the official time responses. Nevertheless, different circumstances as the international UNOPS bid […]
About labeling requirements for medical devices in Mexico
Medical device labeling includes all labels, instructions for use (IFU), and any written, printed, graphical, or electronic information provided by the manufacturer that accompanies a device. Manufacturers worldwide must comply with both international standards and local regulatory requirements when marketing medical devices. In Mexico, labeling requirements are governed by NOM‑137‑SSA1‑2025, which introduces a modern, risk-based approach aligned with global regulatory frameworks. […]
Updates about the UNOPS International Tender Binding for Mexico.
Introduction In recent months there have been new changes in laws and regulations that had led to an international tender for the consolidated purchase of medicines and health supplies for the public sector in Mexico. This is not the first time such process is made, the key difference is that UNOPS (United Nations Office […]
The Mexican Medical Device Market in 2020
Against any projection, 2020 has represented a challenge for any type of industry. The medical device was not the exception. Even though several statistics has been reported, we could not find resources about the Mexican medical device market for this year. And many questions arises among this turmoil. Therefore, we considered that making a research […]