At COFEPRIS's priority lane (VRI) , the transfer of rights for medical devices, pharmaceuticals, pesticides, and plant nutrients will be resolved within 24 business hours, streamlining the process for those involved.
Update
Starting July 8, 2024, the Transfer of Rights process for medical devices, pharmaceuticals, pesticides, and plant nutrients will be expedited within 24 hours through the priority lane (Ventanilla de Resolución Inmediata). This update complements the Regulatory Update: COFEPRIS Ensures Resolutions Within 24 Hours for Some Modifications to Medical Device Registrations.
Applications for medical devices must include the assigned code (homoclave), formatted as COFEPRIS-2022-022-005-A, along with all required physical documentation.
The priority lane will initially accommodate four appointments daily, with plans to expand capacity based on performance evaluations. This initiative ensures that users receive a resolution within 24 business hours of submitting their application. Users should note several key requirements:
Valid Sanitary Registration is mandatory.
The application must not be linked with any other procedures.
The new holder must submit the application.
Changes will adhere to the latest resolution guidelines.
Additional modifications unrelated to the transfer of rights are not permitted.
For detailed information on documentary requirements, please refer to the Guide on Criteria for the Classification of Modifications to Sanitary Registration Conditions.
Regulatory framework
Based on the United Mexican States Political Constitution, the Organic Law of the Federal Public Administration, the General Health Law, the Internal Regulations of the Ministry of Health, and the Federal Commission for Protection against Sanitary Risks.
Effects from the RA update
COFEPRIS is advancing in implementing measures to reduce delays and improve processes by adding 24-hour Transfer of Rights. With this measure, it is possible to change the registration holder to streamline the approval process, reducing the timeframes previously set forth by the legal framework.
Written By:
About ips
Our regulatory affairs team helps medical device manufacturers comply with regulatory requirements to commercialize their products in Mexico. Contact us if you are interested in learning how to transfer your registrations to IPS while maintaining the validity of the sanitary registration. We offer a wide range of services to meet your specific needs.
Email us at info@insumosparasalud.com to learn more.