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 has been enacted to include rights transfers of sanitary registrations, aimed at enhancing the quick-response services offered.
In this article, we will explain the recent update, and provide the necessary requirements for the application process concerning medical equipment.
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 most recent update, this counter will now accept submissions for the execution of sanitary registration rights transfer.
From June the 8th, 2024 onwards, submissions for sanitary registration rights transfers will be accepted in the Immediate Service Counter. Applications received will be resolved within a 24-hour period after submission. It is important to note that this new application will begin with only 4 applications per day, but the number of applications will gradually increase.
The following considerations must be taken into account when planning to submit this type of application. Please note that the following guidelines are only applicable for 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 that will be relinquishing the rights to the registration.
- Additional changes not derived of the rights transfer cannot be requested.
- 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 are possible within the application, as long as:
- They are 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 are provided.
In this scenario, a 75% rights fee is applicable for the submission process.
If you have any inquiries about this update, or if you are a candidate for this application, please feel free to contact us at contact@veraqueconsulting.com.
