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 […]
Classification and Grouping for Orthopedic Implants
As mentioned in our Classification and Grouping Ultimate 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 […]
What do you need to transfer your sanitary registration in Mexico?
A rights transfer is a legal procedure where the Sanitary Registration Holder is changed. In this process the original owner of a Sanitary Registration transfers its rights to another company (the new Holder), as long as critical conditions previously authorized are not changed. The new Holder acquires the rights for manufacturing, importing, exporting, […]
How the regulation for Medical Devices in Mexico changed due to COVID-19
Introduction During the COVID-19 health contingency, various economic activities have been altered. The medical device industry is not an exception. Therefore, in this article we summarize how this sector has been affected in the latest months and what measures the health authorities in Mexico have taken. We will focus on specific medical devices that […]
Sanitary registration modifications in Mexico
If you have an approved medical device sanitary registration in Mexico, it is important to consider that any modification have a great significance in this authorization lifecycle. In this article, we explain in which cases is necessary to request a modification to COFEPRIS. This will help you to avoid problems during exportations or marketing […]
New Cofepris submission guide
Introduction Last 20 February 2020, COFEPRIS issued the Guide for Submissions with the aim of establishing clear rules in the submission process. This document was released by the Sanitary Authorization Comission (CAS) –a division of COFEPRIS that approves Sanitary Registrations, Import Permits and other official authorizations. In this article we highlight the main features […]