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 […]
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, […]
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 […]