Sanitary Import Permit for Medical Devices without Sanitary Registration
The importation of medical devices without sanitary registration in Mexico is feasible, provided there is no commercial purpose. Through sanitary permit COFEPRIS-01-015, it is possible to legally import these supplies without sanitary registration when the purpose is personal use, medical use, scientific research, contract manufacturing (maquila), laboratory testing, or when dealing with used equipment.
Understanding when this permit applies, what requirements must be submitted, and the process for managing it allows for proper planning of a foreign trade operation and reduces the risk of delays during customs clearance.
The entry of medical devices into Mexico is under the supervision of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). Although all medical devices commercialized in the country require a Sanitary Registration, there are operational, medical, and scientific scenarios in which it becomes necessary to import supplies that do not have such authorization. To resolve these situations without compromising sanitary safety, the regulatory framework provides for procedure COFEPRIS-01-015. Understanding its scope allows interested parties to manage the legal entry of these goods and avoid customs delays or sanctions.
What is procedure COFEPRIS-01-015?
Procedure COFEPRIS-01-015 is the sanitary import permit for medical devices that are not or do not contain narcotics or psychotropic substances and do not have a sanitary registration, when the importation corresponds to one of the scenarios specified by the sanitary authority.
This procedure does not constitute a general authorization to commercialize the product in Mexico. Its purpose is to allow the entry of the medical device for a specific purpose, in accordance with the modality under which it is requested.
Among the contemplated scenarios are:
Personal use.
Medical use.
Human research.
Donation.
Contract manufacturing (maquila).
Laboratory testing.
Used medical equipment.
What are the main requirements?
Requirements may vary depending on the import modality. In general, the procedure includes:
Complete the corresponding online form through the VUTCE platform.
Submit proof of payment of rights, when applicable. For the 2026 fiscal year, the current amounts are:
$3,116.65 MXN - intended for scientific research, contract manufacturing, used equipment, laboratory evaluations, and medical use.
$440.45 MXN - intended for donations.
Applications for personal use are exempt from this payment.
Accredit the legal status of the legal representative by power of attorney (or accredit identity with official ID/INE in the case of imports for personal use).
These elements form the basis of the procedure, but documentation may vary depending on the purpose of the import. Therefore, it is important to first identify the applicable scenario and consult the specific requirements established by the sanitary authority, which are available on the procedure sheet at the following page: Sanitary Import Permits for Medical Devices Without Sanitary Registration procedure sheet.
How is the procedure managed?
The procedure is carried out through the Single Window for Foreign Trade (VUTCE).
In general, management involves the following steps:
Identify the purpose of the import.
Verify that procedure COFEPRIS-01-015 is applicable.
Review the specific requirements for the modality.
Gather and prepare the documentation.
Make the payment of rights, when applicable.
Capture and submit the application through VUTCE.
Follow up on the authority's resolution.
Verify that the obtained permit corresponds to the goods and the purpose of the operation before carrying out customs clearance.
The sanitary authority currently establishes a resolution timeframe of 9 business days and a validity period of 180 business days.
Why is it important to manage it in advance?
The sanitary permit is part of the import operation planning. Managing it in a timely manner allows having the corresponding authorization before the goods reach the clearance stage and facilitates the coordination of sanitary, customs, and logistical aspects of the operation.
Additionally, anticipating management allows for:
Avoiding delays during customs clearance.
Planning operational timelines.
Reducing risks related to the lack of sanitary documentation.
Verifying that the declared purpose is consistent with the product's use.
Anticipating potential requirements from the authority.
Therefore, reviewing the requirements for this type of operation should be part of import planning prior to coordinating the shipment of goods.
Conclusion
The sanitary import permit for medical devices allows certain importations of medical devices without sanitary registration when a specific purpose provided by regulation exists. However, its correct application depends on the characteristics of each operation and the modality under which it is requested.
For proper import planning, we recommend:
Define the purpose of the operation from the beginning, as this will determine the applicable scenario and requirements.
Review product information before coordinating shipment to identify sanitary requirements in a timely manner and avoid later adjustments.
Consider resolution timelines within logistical planning, especially when the goods have a committed delivery date.
Verify that operation documentation is consistent, from product information to the purpose declared in the permit.
Consult current official information before submitting the application, as requirements and applicable provisions may be updated.
Proper regulatory planning from the beginning helps reduce risks and facilitates carrying out the import in an orderly manner and in accordance with applicable provisions.
FAQ
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No. The permit authorizes importation for a specific purpose and does not substitute the sanitary registration required to commercialize the product when applicable.
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Not necessarily. It must first be verified that the purpose of the import corresponds to one of the scenarios covered by the procedure.
Written by:
Dulce Ángel
Logistics Analyst at Insumos para la Salud, S.A. de C.V., with experience in coordinating international operations and regulatory compliance for the chemical and healthcare supplies sector. She has training in process optimization methodologies under Lean Six Sigma (Green Belt level).
About IPS
If your company plans to import medical devices into Mexico, IPS can provide you with regulatory and logistics consulting. Our team of experts in sanitary regulation, customs procedures, and logistics is ready to help you ensure a streamlined and compliant import process.
To learn more about our services, contact us at info@insumosparasalud.com