As you know, our team has the compromise to bring you updates and useful information to help you succeed in every international trade you realize. That’s why, last week, we talked about free trade zones and how to take advantage of them.
In today’s article, we will develop a more specific area of commercializing goods, specifically importing medical supplies. This is a critical process that supports healthcare systems worldwide.
From personal protective equipment (PPE) to advanced diagnostic tools, ensuring that these essential products reach their destinations safely and on time is vital for patient care and public health. However, the importation of medical supplies involves navigating a complex landscape of regulations, customs procedures, and quality standards.
That’s why, as mexican customs brokers, we prepared this guide to provide you with a step-by-step approach to successfully importing medical supplies. It covers the key regulatory requirements, documentation, and logistics to streamline the import process while ensuring compliance with international health and safety standards.
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How to know if a product is a medical device?
First, we must determine whether a product is classified as a medical device. For this, it’s essential to consider its intended use, functionality, and how health authorities regulate it.
Medical devices are typically products designed for medical purposes, such as diagnosing, preventing, monitoring, or treating diseases or injuries. They may also be used to support or sustain life, alleviate disabilities, or modify physiological processes. Common examples include surgical instruments, diagnostic tools, and implantable devices.
However, each country has specific regulatory definitions for medical devices, though these can vary slightly. For instance, the U.S. Food and Drug Administration (FDA) defines a medical device as any instrument, apparatus, or related article intended for use in diagnosing, curing, treating, or preventing disease.
While in the European Union, the Medical Devices Regulation (MDR) focuses on the intended medical purpose and interaction with the human body. Understanding how your country defines a medical device is key to determining if a product falls within that category.
How does Mexico define a medical device?
In Mexico, a medical device is defined by the Ley General de Salud and its corresponding regulations, specifically by the Comisión Federal para la Protección contra Riesgos Sanitarios, the regulatory authority overseeing medical devices.
According to Mexican regulations, a medical device is defined as any instrument, apparatus, utensil, machine, software, or material used alone or in combination, including accessories or programming necessary for its proper use, whose primary purposes are:
- Diagnosis: Helping to diagnose diseases or conditions in humans.
- Prevention: Aiding in the prevention of disease.
- Monitoring: Keeping track of physiological or pathological conditions.
- Treatment: Being used in the treatment or alleviation of diseases or injuries.
- Rehabilitation: Helping with rehabilitation or compensating for physical disabilities.
- Replacement or Modification: Replacing or modifying body structures or functions.
Types of medical devices import permits
By covering this purpose, each medical device will be classified into different categories, and each will respond to a certain customs procedure.
Case 1 – With sanitary registration
This is the most frequently requested import permit from COFEPRIS, as it is regularly used by companies importing a wide range of medical devices in large quantities for sale. The request for this permit must be submitted either by the holder of the sanitary registration or by an authorized distributor.
A common misconception is that all medical devices with sanitary registration do not require an import permit. However, while this type of permit is only necessary for certain categories of medical devices, such as some implants or high-risk products, it is highly recommended to consult with your customs broker to determine the correct medical device tariff code and confirm whether your products will need an import permit.
For medical devices that include radiation sources, such as X-ray machines or radiopaque agents, an additional import permit issued by the Comisión Nacional de Seguridad Nuclear y Salvaguardias (CNSNS) is required.
Case 2 – For third-party manufacturing
In this case, the medical device is temporarily imported for a third-party manufacturing process at any stage. That’s why the Secretaría de Economía or IMMEX must issue the authorization.
Case 3 – For personal use
The third case applies only to patients who need a medical device that is unavailable in Mexico. In these cases each patient must request the import permit directly to COFEPRIS by submitting a valid medical prescription indicating the medical device information and the quantity needed, the import permit will be limited to this quantity.
Case 4 – For professional use
The next scenario applies to medical devices intended for exclusive use by a physician. This type of import permit is particularly useful for hospitals that require devices that are unavailable in Mexico.
In these cases, the physician must request the permit on behalf of the patient receiving treatment. Legal documentation, such as the physician’s professional ID, must be submitted to COFEPRIS. Additional requirements apply if the device is classified as Class II or III or an X-ray device.
Typically, evidence must be provided to demonstrate that no comparable technology is available in Mexico to justify the importation. Similar to previous cases, this permit is limited to the specific number of devices needed for the treatment of a particular patient.
Case 5 – For human subject research
Research centers, universities, and private organizations, such as Clinical Research Organizations, request this type of import permit to bring medical devices for clinical research studies. For this, they must have a clinical research protocol approved by COFEPRIS.
Case 6 – Donations
This type of permit is applicable when a foreign organization donates a medical device to public, social, or private health institutions in Mexico. The receiving organization must request the permit, specifying the device being imported and ensuring that the product will not be sold.
Case 7 – Previously owned
This scenario is particularly relevant for those importing high-end or expensive medical devices. To obtain the necessary permit from COFEPRIS, an invoice proving that the device is not new must be submitted, along with a statement confirming that the device is in proper working condition.
It’s important to note that misuse of this type of import permit has led COFEPRIS to tighten restrictions or deny approvals in some cases.
Case 8 – For laboratory testing
In opposition to case 5, this import permit is for medical devices used in laboratory tests that do not involve humans.
Now that you’ve learned more about how to import medical devices to Mexico, don’t hesitate to contact us for more assistance. Also, if you find this article helpful, share it on social media and stay tuned to our blog for more updates.