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 […]

About labeling requirements for medical devices in Mexico

Introduction   Medical Device labeling includes all labels and printed text or graphics directly on the device or its primary or secondary packaging. Worldwide manufacturers follow international standards and local directives or regulations when labeling its products. However, there are special requirements for medical devices labeling to be distributed in Mexico. In this text we […]

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 […]

About apostilled documents in the medical device industry

All Medical devices companies which import or export their products between different countries often deal with several legal documents required by the authorities. Such legal documents issued abroad need to be authenticated to be considered as valid by the authority from other country. However, the process of authentication of this kind of documents might be […]

About the UNOPS international tender binding for Mexico

Is this a real opportunity for those Medical Device manufacturers to participate without a sanitary registration?   As published by the UNOPS (United Nations Office for Project Services) the last 25 of August 2020, the Mexican Public Healthcare system signed an agreement to promote an international tender binding for all those companies interested to sell […]