As a means to make regulatory processes more accessible and efficient to everyone in the medical device sector in Mexico, COFEPRIS started an upgrading strategy to turn to the digital approach when trying to submit information pertaining regulatory affairs. Thanks to this digitalization process, many of the old regulatory paths regarding the acquisition and upkeep of sanitary authorizations can now be accessed via the COFEPRIS digital platform.
One of these improved pathways is related with the renewals of the sanitary registration. Before this digital upgrade, the procedure was to be made in person. Now, the process is 100% digital, requiring you to submit digital copies of the documentation via the new platform.
In this article, we aim to give you a brief introduction to the requirements of both, the 1st time and the 2nd and subsequent extensions, that your sanitary registration needs to obtain in order to remain valid.
First Extension
The first extension of your sanitary registration must be processed at least 150 days before the expiration date (though, we recommend to initiate this process at least 190 days to submit the technovigilance report). As mentioned above, the entirety of the process is to be made via the digital platform. Once logged on, you must procure the following digitalized documentation:
- Application Form and Payment Fees
As with every type of regulatory application, the form serves as the basis of submission to COFEPRIS. It details what type of service you are requiring and serves as the entry point for your renewal process. It must be accompanied by the payment of the corresponding fee.
It is worth noting that the application form for an extension process is exclusive to its type, and may only be used for this kind of process. As such, you cannot use the typical application form for other types of submission (e.g., new registrations or modifications of existing sanitary registrations). You can find the latest application form in the COFEPRIS official website.
- Power of Attorney and RUPA
The Power of Attorney consists of a written statement in which you recognize and officially appoint a company and/or a person as your legal representative in Mexico, to act on your behalf in managing all your regulatory affairs before COFEPRIS regarding your products.
The RUPA, on the other hand, is a digital identification system that allows a more seamless interaction for the legal representatives of an organization to fulfill the legal acknowledgement requirements of diverse official government-related processes.
Remember to produce the adequate documentation according to the path you choose to take:
- For the power of attorney, the top copy of the document, duly notarized and authenticated.
- For the RUPA, a simple copy of the proof of registration will suffice.
- Technovigilance report per product
For more detailed information on the Technovigilance report, we encourage you to check out this article.
- Representation letter issued by the manufacturer
Also known as a Letter of Authorization (LoA) or Letter of Representation, this document is a valid legal agreement between two parties in which one party (in this case, the company aiming to sell its product in Mexico) acknowledges its designated companies, filial, subsidiaries or partners and endows them with the appropriate attributions to act on its behalf.
You will need to submit the copy of the document, duly notarized and authenticated.
- GMP certificate (or equivalent document)
For more detailed information on the GMP certificate, we encourage you to check out this article.
Second and subsequent extensions
For the second and subsequent extensions of your sanitary registration, there are some substantial improvements on the overall process:
First, the number of documents you need to submit is significantly reduced. You would only need to submit the documentation detailed on the previous paragraphs regarding items 1 and 2 of the first extension (Application Forms, Payment Fees and Power of Attorney and RUPA). Also, as a final piece of documentation, you need to submit a copy of the sanitary registration.
In contrast with the first extension process, the second and subsequent extensions will not require a verification term, and it will authorize the extension instantly after submitting the correct documentation.
Conclusions
Navigating the new medical device renewal processes is a much simpler affair than the previous iteration. If you need support explaining any one of the requirements described in this article, please contact us at contact@veraqueconsulting.com or check our guidelines or checklists.
