COFEPRIS regulates the transfer of rights to ensure legal and technical compliance for medicines, medical devices, and biological products. Requirements include an application format, proof of payment, legal documentation, and a notice of operation. Transfers must be transparent, with continuous monitoring. Modifications now resolve within 24 hours instead of 3 months.
The transfer of rights in the regulatory context is essential to ensure continuity and legality in the management of rights and obligations related to regulated products, such as medicines, medical devices and biological products, among others.
COFEPRIS regulates this process with the objective of guaranteeing that any transfer of rights is carried out in a transparent manner, ensuring that the new owners comply with the legal and technical requirements necessary for the proper operation and marketing of products under their responsibility. This includes evaluation of relevant documentation,verification of the transferee's suitability, and ongoing monitoring to ensure compliance with applicable regulations.
The requirements for the transfer of rights to medical devices are:
1. Application format
2. Proof of payment of rights
3. Accreditation of legal personality
4. Tag projects
5. Instructions/user manual project
6. Number or copy of the last registration document
7. Legal instrument that certifies the transfer
8. Letter of Representation
9. Notice of operation
10. Notify the transfer within 30 business days
Apart from the indicated requirements, the following must be considered:
• Application entered by assignee.
• Registration must be current.
• It should not be linked to any other procedure entered into the commission (technical/administrative modification, extension among others).
• Changes checked will be in accordance with the latest resolution.
• The Health Registry must be current. In case of presenting proof of Extension, the holder of the same must coincide with the transfer or in accordance with article 190 bis 5 of the RIS.
• Download, fill out and physically present the“Modification to the Conditions of the Health Registry” form, which must describe the conditions requested according to the modification (Says/Should say). Attach a letter with information that describes in detail the request signed by the legal representative.
• Download, fill out and present the “Medical Device Health Registry Project” format in editable digital format.
• Changes may be made in the “importer and distributor” category as long as they are reflected in your new label project. In which case, in addition to the rights transfer contract, they must present the letter(s) of representation that cover the actors in the supply chain and/or, where appropriate, a certified copy of the Letter of Representation or clarification in which A distributor has the power to appoint others as distributors. (In this case, 75% of the fee corresponding to the LFD registration will be paid).
• All information regarding the procedure must be presented in printed form.
The steps to follow to submit the procedures for immediate resolution modifications are:
1. Request an appointment at the Comprehensive Services Center (CIS) through the Appointment Request System to carry out COFEPRIS procedures.
2. Present the requirements indicated in the COFEPRIS Procedures and Services Agreement, in physical format.
3. After entering the procedure, the user will receive a security paper document within a maximum period of 24 hours, without the need to schedule an appointment for collection.
This guide was published on June 25th 2024and it starts operation until July 8, 2024, according to COFEPRIS web page.
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