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 […]
Updates about COFEPRIS strategies to become digital
In the last months, COFEPRIS has been implementing different activities to digitalize new procedures focusing on a paperless policy. In this article, we briefly describe the expected digitalization transfer and how the regulatory process in Mexico may be impacted. COFEPRIS has initiated an ambitious project to digitalize the regulatory processes in a similar way […]
COFEPRIS legal structure changes
As we have previously explained in our Guide and Article, COFEPRIS is the regulatory arm of the Ministry of Health in Mexico which regulates the manufacturing, importation, marketing, and other activities related with health supplies including medical devices. Up to August 19, 2020 according to the Health Law, COFEPRIS was a separated administrative commission […]
Changes in the medical device market in Mexico resulting from the COVID-19 (part II)
In recent months, due to the global pandemic, there have been several changes in medical devices market and its regulation in Mexico. In this article, we describe the most relevant changes that any regulatory affairs professional in the industry shall consider. You can also check our first update in this link. Submissions to […]
