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 […]
Technovigilance for Medical Devices in Mexico
Introduction Technovigilance or Medical Device Surveillance is the activity that guarantees that any medical technology in Mexico is correctly working and describes how to report any incident related to the device. In this text, we summarize the technovigilance requirements in Mexico. Specifically: How to identify an adverse incident, When to report and not report […]
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 […]
