On December 4, 2024, an agreement was published in the Official Journal of the Federation (DOF), outlining the requirements for importing medicines and medical devices for the public sector. This agreement allows importing these products without a COFEPRIS sanitary registration, provided certain criteria are met. It aims to expedite supply processes, especially for consolidated purchases under BIRMEX scheme.
Update
The agreement introduces significant changes to the process of obtaining import permits for health supplies intended for the public sector in Mexico.
Included Products:
Medical Devices.
Medicines, including:
New molecules listed in Article 2, Section XV of the Health Supplies Regulation.
Generics.
Innovative and comparable biotechnological products.
Biological products.
Regulatory Approvals:
Commercialization authorizations and sanitary registrations issued by the Regulatory Authorities mentioned in the agreement will be accepted
For medicines, the commercialization authorizations and sanitary registrations from Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Japan, Singapore, Spain, Sweden, Swiss, USA, Canada, Australia and United Kingdoms will be accepted
For medical devices, the commercialization authorizations and sanitary registrations from the USA, Republic of Korea, Canada, Brazil, Singapore, Japan, Australia and Swiss will be accepted
Authorizations and registrations issued by the European Commission and the European Medicines Agency (EMA) obtained through a centralized process will also be valid.
Only approvals obtained through standard processes will be accepted; those issued for emergency use only or expedited circumstances will not be valid.
Additional Requirements:
Companies must initiate the process to obtain a sanitary registration with COFEPRIS within 10 business days following the first importation.
Effects from the RA update
This regulatory update allows companies to request an import permit for medical devices and medicines without sanitary registration previously issued by COFEPRIS.
This update also points out the importance of processing the sanitary registration application in México before COFEPRIS, since it is mandatory to submit this application within ten working days after the importation. These applications can be processed in parallel, optimizing administrative timelines while ensuring full compliance with established regulatory requirements.
Written By:
Dulce Ángel
About ips
Our team helps medical device manufacturers comply with regulatory requirements to import and commercialize their products in Mexico. Contact us if you are interested in learning how to import your products, any assessment about importation and obtaining the sanitary registration for your product. We offer a wide range of services to meet your specific needs. Email us at info@insumosparasalud.com to learn more.