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:
Before this announcement, the Ministry of Health required that any submission must be presented in Spanish. In other words, any manual, test or clinical reports must be translated. In addition, legal documents must be translated by an expert translator located in Mexico. This represented different types of challenges for the industry because a submission could require several pages to be translated (200-600 pages based on our experience) and the expert translator added an extra fee.
Considering that English is the lingua franca in the field, the Ministry of Health states in this update that any document to be submitted could be presented in English or Spanish. This is applicable even for legal documents, as long as they come in English or Spanish from origin.
That being said, this will save you money for the regulatory process and avoid extra complications to the regulatory affairs departments in charge to submit any process in COFEPRIS.
Another key amendment in the Health Supplies regulation is the fact that the renewal process changes.
Being more specific, before this update, any sanitary registration in Mexico must be renewed every 5 years, presenting legal documents and some technical information. Now, after 5 years you only present information one time for the renewal. In addition, technical information is no longer required. Then, after those 5 years, the subsequent renewals only require a notification and not a formal response from the authority.
This definitely ease the renewal process in Mexico, that before this update presented inconveniences when the renewals were not approved on time and product was stocked waiting for an approval.
An important note to consider is that for renewals, the Ministry of Health states that an specific format must be used. Specifically, the authority has 180 days to present this format and that is when the mentioned renewal process will work in practice. In other words, this will not take place immediately.
Finally, there are other changes that could impact the rights transfer process but the document is still not clear about it. We will be in close communication with the authorities looking to provide the most updated information. In case you have any question or comment, feel free to contact us at firstname.lastname@example.org