In Mexico, obtaining an import permit is an important step for importing medical devices. This document allows medical devices to enter the country and ensures compliance with health regulations. Companies without this permit may experience customs delays, fines, and operational problems, all of which can increase costs and delivery times.
To avoid these issues, it is essential to know what an import sanitary permit is, what devices need this document, and how to obtain it.
The import permit is a document issued by COFEPRIS that authorizes the entry of certain medical devices into Mexico, ensuring compliance with the sanitary regulations established for their importation.
Depending on the type of medical device and its intended use, this permit may have different modalities and requirements, making it essential to understand the process to avoid import delays. Detailed information on the available modalities and specific requirements can be found at the following link: https://www.gob.mx/cofepris/acciones-y-programas/permiso-sanitario-de-importacion-de-insumos-para-la-salud-tramites
This permit applies to a wide range of medical devices, including:
Medical equipment (monitors, ultrasounds, etc.).
X-ray machines.
Heart valves and pacemakers.
Internal and external prostheses.
Dental supplies.
Surgical and wound care materials.
If a product falls under any category that requires an import permit, obtaining it before importation is essential.
To apply for an import permit, it´s important to determine whether the medical device has a valid sanitary registration in Mexico or if it requires a special import modality, such as those for research, laboratory testing, or medical use.
The requirements depend on the importation modality and the documents that may be required are the importer's operating notice or sanitary license, the device’s sanitary registration, among others. In the case of medical devices without sanitary registration in Mexico, the requirements may differ based on their intended use, so it is essential to review the specific regulations applicable to each case.
Once the application is submitted, COFEPRIS evaluates the information and issues a resolution. By law, the review time varies according to the modality; however, in most cases, it is 40 business days. If the permit is approved, the importation can proceed under the conditions established by the health authority. Additionally, the permit is valid for a maximum of 180 calendar days and may be extended for an equal period, as long as the same conditions that allowed it to be granted are maintained.
Complying with sanitary regulations is a crucial step in the importation of medical devices into Mexico. Properly managing the import permit helps prevent setbacks that could delay the arrival of products into the country.
Each case may have specific requirements, so understanding and correctly handling the process is essential. A well-planned import ensures that medical devices arrive on time, ready for use or commercialization.
Written By:
Dulce Angel
about ips
If your company needs support to comply with COFEPRIS regulatory requirements, IPS has a team of experts in health regulation to assist you.
Contact us at info@insumosparasalud.com for more information about our regulatory services.