The Immediate Service Counter is a measure implemented by The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) to improve and simplify submission processes regarding sanitary registrations. An important update on its scope was enacted in June 2024 to include rights transfers of sanitary registrations, aimed at enhancing the quick-response services offered.
In this article, we outline the scope and requirements of this update for reference purposes, as submissions through the Immediate Service Counter are no longer being accepted as of September 2025. While no official communication has been issued regarding its permanent deactivation, the pathway remains suspended in practice.
Rights Transfer Update: Guidelines and Requirements
As explained in our previous article, the Immediate Service Counter serves to simplify some regulatory processes, providing better results and shortened evaluation and resolution times. With the update performed in June 2024, the counter began accepting submissions for sanitary registration rights transfers.
From June 8, 2024, COFEPRIS allowed up to four applications per day for rights transfers through this pathway, with plans to gradually increase capacity. Applications were resolved within a 24-hour period.
The following considerations applied specifically to medical devices:
- The sanitary registration must not be expired.
- The application must not be linked to an active application (i.e., a technical modification pending resolution or an extension process)
- The application must be submitted by the individual or legal entity relinquishing the rights to the registration.
- Additional changes not derived of the rights transfer were not permitted.
- All the documentation must be submitted in printed form.
When submitting an application for a rights transfer, the following documentation must be provided:
- Application form and payment of fees
- Power of Attorney
- Label and Registration designs, in editable format
- IFU of the product
- Number or copy of the last official registry document
- Legal instrument that validates the rights transfer
As a final note, it is important to mention that changes (addition or removal) in the importers and distributors outlined in the registration were possible within the application, as long as:
- They were outlined in the Label and Registration designs, and
- Their respective Warehouse and Health Quality Manager Notices, along with the proper Representation and/or Distribution letters were provided.
A 75% rights fee applied to these submissions.
If you have any inquiries about historical applications or current alternatives, please feel free to contact us at [email protected].