It is essential to provide clear information on the key regulatory and operational requirements for importing medical devices into Mexico, emphasizing compliance with applicable laws, proper documentation, and the critical role of effective logistics coordination.
Importing medical devices into Mexico involves a series of steps regulated by health and customs authorities. Because of their impact on public health, these products must meet specific requirements from their origin through to commercialization. Therefore, proactive planning and specialized advice are essential to avoid setbacks.
Before importing a medical device, keep in mind that these products are subject to strict health regulations, and compliance must be ensured from the logistics planning stage. The nature of these products requires not only documentary precision but also effective coordination among technical, commercial, and logistics departments.
Below are some essential points every importer should consider to ensure a successful import process:
1. Product Identification and Applicable Regulations
Before initiating any procedure, it is essential to determine whether the medical device has a valid sanitary registration with the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and whether a Sanitary Import Permit is required. The classification of the product as a medical device should be based on its intended use, under the General Health Law.
2. Tariff Classification and Specific Regulations
Determining the correct tariff classification is essential, as it impacts not only the calculation of taxes and duties but also the identification of applicable sanitary regulations and restrictions, such as the requirement for a Sanitary Import Permit (SIP). It is advisable to request a classification ruling with the support of expert advisors or your customs broker to ensure an accurate and compliant classification.
3. Sanitary Import Permit
The Sanitary Import Permit is a document issued by COFEPRIS that authorizes the entry of specific medical devices into Mexico, subject to the conditions established by applicable health regulations. Its issuance often depends on the correct tariff classification and the initial identification of the product.
If you want to know more about import permits for medical devices, you can consult: IPS News - Import Permit for Medical Devices.
4. Essential Documentation for Customs Clearance
To successfully clear medical devices through customs, the following documentation is typically required:
Commercial Invoice.
Packing List.
Sanitary Registration.
Valid Sanitary Import Permit (when applicable).
Air Waybills.
It is crucial to ensure that all documentation is complete and available before the goods arrive at customs, and ideally before they leave their point of origin. This is key to avoiding discrepancies that could lead not only to significant delays, but also to detentions, fines, or even the return of the products.
5. Prior Storage and Transport Conditions
The integrity of a medical device depends not only on proper documentation but also on its physical handling and the environmental conditions it is exposed to during transit and prior to customs clearance. It is essential to ensure that the product is transported and stored under appropriate temperature and humidity conditions, particularly for items that are sensitive or require cold chain management. Close coordination with the freight forwarder and customs agency is crucial to monitor and maintain these conditions as a key preventive measure to avoid product deterioration, rejections, or quality-related incidents.
6. Coordination with Customs Broker and Forwarder
The successful release of goods depends largely on effective coordination among all involved parties: the importer, customs broker, and freight forwarder. It is highly recommended to anticipate any potential documentary or logistical inconsistencies, especially for sensitive products or those requiring specific temperature controls.
Importing medical devices into Mexico involves a set of unique regulatory and logistical considerations. However, by understanding and applying these key principles, importers can navigate the process with greater confidence and efficiency. Thorough planning from the point of origin, combined with close collaboration with industry experts, not only helps prevent delays and complications but also ensures the timely and safe arrival of critical products that support public health.
Written By:
Dulce Ángel
about ips
If your company is planning to import medical devices into Mexico, IPS can support you with tailored regulatory and logistical guidance. Our team of experts in health regulation, customs procedures, and logistics is ready to help you ensure a smooth and compliant import process.
Contact us at info@insumosparasalud.com to learn more about our specialized import support services.