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August 15, 2019
By
Julia Hecht

Shipping Medical Devices From Mexico

If you’re interested in shipping medical devices from Mexico, then you probably know that the process is highly regulated. However, you may not know that importers ship from Mexico into the U.S. all the time. In fact, a lot of the manufacturing companies in Mexico are actually American owned, so regular transport across the border is commonplace! The value of Mexico’s medical device exports totaled $11.6 billion USD in 2017, and trucks are constantly moving through the ports of entry, but that does not mean it will be easy. 

Shipping medical devices from Mexico is a tense process. Devices must be appropriately classified, labeled, approved, monitored, and registered in order to gain clearance from the FDA. Additionally, importing from Mexico into the U.S. has other regulations, like a BOL, a customs bond, and a NAFTA certificate of origin. 

What Medical Devices are Made in Mexico?

Factories in Mexico are now responsible for producing a huge variety of the medical devices in use in the U.S., and there are few limits on what they produce. The definition for medical devices in Mexico is wide-reaching and encompasses substances, electronics, instruments, software, and other equipment that is used in healthcare. This includes anything used to treat, diagnose, monitor, or prevent illnesses, as well as aesthetic and functional prosthetics used to correct disabilities or dysfunction. Anything involved in the alteration of anatomy and physiological processes, such as aesthetic implants, is also included in this definition. 

Although that sounds confusing, it basically means that anything used for healthcare purposes in a medical facility falls under the definition of “medical device.” Even hospital gowns and tongue depressors are included in that definition!

Take a look at some of the medical devices commonly manufactured in Mexico:

  • Cardiac pacemakers
  • Thermometers
  • Blood pressure cuffs
  • Hearing aids
  • Wheelchairs
  • Dentures 
  • Surgical instruments
  • Dental instruments
  • Replacement heart valves
  • Imaging equipment 
  • Surgical drapes

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What is COFEPRIS?

COFEPRIS, the Federal Commission for Protection against Health Risks, is part of the Mexican Ministry of Health, and it is the division responsible for overseeing medical devices and In Vitro Diagnostics (IVD). It is the regulatory division for protecting people from devices that could be manufactured poorly, not sterile, poorly designed, or otherwise harmful to patients. 

Think of this division as the Mexican equivalent of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). That’s a bit of a mouthful, but the activities that COFEPRIS is engaged in are fairly simple.

COFEPRIS duties include:

  • Classifying and registering medical devices
  • Regulating the import and export of medical devices
  • Monitoring and regulating the use of registered medical devices
  • Issuing recalls on faulty medical devices
  • Establishing and enforcing labeling requirements for medical devices
  • Regulating the manufacture of medical devices
  • Monitoring and controlling health facilities
  • Restricting advertising activities for medical devices
  • … And much more!

NAFTA and Medical DevicesNAFTA and Medical Devices

The North American Free Trade Agreement (NAFTA), now replaced with the United States-Mexico-Canada Agreement (USMCA), is a trade agreement between those three countries to remove tariffs and other foreign trade barriers on certain commodities. Although the terms that were renegotiated in 2017 negatively impacted many industries, the medical device industry faced a few potentially beneficial changes—for consumers and manufacturers!

Some of these changes are:

  • The harmonization of regulatory compliance, to reduce processing time at the borders
  • Improved medical device reimbursement rates
  • Higher quality cross-border audits
  • Duplicate requirements removed between countries
  • Clearer frameworks for exporters to ensure the safety of their devices
  • A method to fix noncompliant medical device labels at the port of entry, instead of refusing entry and restarting the process

Those are only a few of the ways that the trade agreement benefits the medical device industry, to cut down on border crossing times. These policies also reduce the final costs and improve the quality for the final consumer. 

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Medical Device RegulationMedical Device Regulation

Thanks to the USMCA harmonization of medical device regulation, you should not need to worry about redundancies in the process of getting your shipment across the border. However, that does not mean that it will be easy. The process for regulating medical devices is a complicated one, and there are many things you need to know to ensure regulatory compliance. 

Medical Device Classification System

Before being exported from Mexico, medical devices must be classified into different categories based on their potential risk. There are three different classes that medical devices can fall into:

  1. Class I devices are those that are considered to have little to no risk. These include things like stethoscopes, tongue depressors, and hospital gowns. In general, these devices are not intended to save or preserve human lives.
  2. Class II devices are riskier than Class I, and could potentially cause serious harm if they are faulty. These devices are things such as syringes, electric wheelchairs, and surgical drapes. They generally play a major part in preserving human lives, but they are not usually the primary lifesaving device.
  3. Class III devices are where things get tricky. These tend to be difficult to import since they are intended for use to sustain or support human life, and can be much more dangerous to use than the other two Classes. A faulty device could result in serious harm, or even death. These things include devices like pacemakers, artificial heart valves, ventilators, and defibrillators. Additionally, anything that poses an unusually high risk to personal safety or health is categorized as Class III, like aesthetic implants.

Device Labeling

Medical device labeling is an important part of preparing for import into the U.S. In order to be compliant, all devices must meet a set of minimum requirements. Depending on the device, its Class, and where it will be used, there may be more specific requirements to follow as well.

At the very least, all medical devices must have:

  • The name, address, and contact information for the manufacturer, the packer, or the distributor
  • A statement to affirm who the product was manufactured or distributed on behalf of, if applicable
  • A description of the intended use for the device
  • Directions for use, including frequency of use, preparation before use, and any other instruction that would need to be communicated to the average user
  • A statement to affirm for what condition(s) the device is intended to be used for

Failing to follow these labeling requirements could result in serious delays, but it is unlikely that your devices would be turned away just because of mislabeling, as long as the mistakes were not deliberate. Chances are, the faulty labels could be fixed at the port, and then brought over the border. 

Premarket Approval

The regulatory approval process for Class III medical devices is extremely stringent. In order to market a potentially life-saving or risky device, you would need to file a Class III 510(k) with the FDA. The FDA will then investigate the device to ensure that it is effective for its intended use or uses, without causing an unreasonable amount of harm to the user or patient. 

If the FDA determines that the device is allowed to enter the U.S. market, then the device is granted Premarket Approval (PMA), and you can move on to the next step.

Class I and II devices do not need to file for PMA, but shippers do need to file Premarket Notification (PMN). This is another 510(k) document, but it does not entail as close of an inspection as those for Class III devices. PMN should be filed at least 90 days before the date of their intended introduction to market, since you will not be able to market your medical device until after this PMN has been acknowledged by the FDA.

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Postmarket Surveillance 

Postmarket surveillance is when a device that has been released to the public for the first time is monitored and tested, to ensure that it effectively does what it claims, and does not cause undue harm. Usually, this requires keeping up with the users of the device, and making note of everything. Any complications regarding the device is investigated, to see if it trends as being more harmful than helpful. 

Postmarket surveillance is helpful for determining how the device works on large, diverse groups of people, while continuing to ensure safety and quality. If a large percentage of people experience the same concerning complications as a result of the device, it may be determined to be harmful on that statistical basis. 

If a device is found to cause unreasonable harm, is unpredictable, unreliable, or otherwise concerning, the FDA maintains the right to pull the device from the market to protect the general population. Fortunately, if your device is pulled from the market, you could still try to fix the problems with it and re-register with the FDA to get back onto the market.

This postmarket surveillance is required for Class III devices, and sometimes Class II devices, but Class I devices are usually exempt.

Registration Process

The registration process for medical devices is a fairly simple one, but you should still make sure you read through all the instructions carefully. In order to register a device in Mexico for export, you must submit specific documentation to the FDA, including:

  • Evidence of the device’s risk Class and industry family
  • Proof of clinical research studies
  • PMA or PMN application approval, and evidence of fee payment
  • Proof of FDA inspection of production facilities

For the most part, Class I devices do not need to follow this procedure, as they are easily self-registered.

Packing and Shipping Medical DevicesPacking and Shipping Medical Devices

The best practices for packing and shipping medical devices really depends on the type of medical device you’re shipping. As demonstrated earlier, the medical device industry is huge, and encompasses many different types of products. Additionally, you’re going to need to know the specific processes for clearing customs for Mexico cross-border shipping. 

Storage and Handling

Shipping something like boxes of latex gloves would be ideal, since they would be easy to palletize and they do not require any special treatment to ensure they stay intact during shipping. Other items have special requirements, however. Electronics like pacemakers and hearing aids, for example, cannot be allowed to get wet. Likewise, some items may require specific temperatures to be maintained during transit, like disinfectants and burn treatments.

Failure to store your medical device correctly will most likely result in your product becoming unusable. The FDA does not want to take chances with people’s health, so even if it doesn’t seem like there is anything wrong with your product after storing it improperly, it likely won’t be accepted anyway. 

It is important to communicate the specific instructions for storing your product to your carrier, to ensure that no mistakes are made. However, mistakes can be made anyway, and they can be difficult to catch before it’s too late. But there is a solution!

If you work with a third-party logistics company, you could ensure that your carrier is trustworthy, and even set up special tracking modules to monitor the speed, temperature, and location of your shipment. You could notice if the temperature isn’t correct before your shipment gets damaged.

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Border Crossing

As with any import, importing medical devices from Mexico to the U.S. is going to require some specific documents to clear customs. In order to be allowed through customs, the shipment will need to be accompanied by:

  • A Mexican Bill of Lading, or Orden de Servicio, in Spanish or English
  • An Export Pedimento in Spanish
  • A NAFTA Certificate of Origin
  • An Automated Commercial Entry (ACE) filing
  • A Commercial Invoice
  • A Customs Bond
  • A Packing List
  • An Import Permit

A licensed customs broker can assist you with getting all the documents for your shipment in order. It is a complicated process, and it can be a lot to manage if you’re trying to do it all without any help. A customs broker can also assist with keeping you up to date on changing regulations, and can handle all the paperwork on your behalf. 

Medical Device Supply ChainMedical Device Supply Chain

Medical devices manufactured in Mexico start in special assembly plants known as maquiladoras, which are typically American owned operations, commonly located in border towns in Mexico. These plants usually ship in raw materials, either from other places in Mexico or the U.S., assemble the parts into finished products, and then export them into the U.S. 

Once a product is finished, it goes to a warehouse to be stored until it can be shipped out in a freight truck. These warehouses may require additional features to ensure the highest quality and safety for the products, like extra guards or refrigeration. When it is time to move the products, they are loaded onto freight trucks and taken to a Port of Entry to cross the border. These ports can be found in places like Laredo, El Paso, and San Ysidro.

Once in the U.S., the products are then moved into another warehouse, where they will be kept until they are ordered by a hospital, drugstore, or other customers. When an order is received, the items are packed onto another truck to be delivered. 

Choosing a Freight Service for Shipping Medical Devices from Mexico

The Federal Motor Carrier Safety Administration (FMCSA) dictates that all carriers moving over the border must be appropriately licensed and certified to operate in both the U.S. and Mexico. Otherwise, you would need a Mexican-domiciled carrier to take your cargo to the port, then load it onto a U.S. carrier to finish the trip, which can cost you time and potentially damage your shipment. 

When selecting a freight service for shipping medical devices from Mexico, it is important to find a carrier that is trusted and well respected, with a reputation for successful deliveries. When dealing with Mexico cross-border shipments, it can be difficult to monitor your freight, so you should try to find a carrier that will be open and willing to communicate with you transparently. 

Alternatively, you could utilize a global third-party logistics company (3PL) to handle the hard work for you. They could find you a trusted carrier to move your freight, and can be a point of contact between you and the carrier so you can always know what’s going on with your shipment. Working with a 3PL can give you the greatest chance of success, and seriously reduce the chances of something going wrong with your shipment. 

Ship Medical Devices with R+L Global Logistics

Shipping medical devices from Mexico doesn’t have to be a difficult task. With R+L Global Logistics, you don’t have to stress about dealing with carriers. Our multi-lingual staff has over 30 years of cross-border experience, so you can rest easy knowing that your shipment is in good hands! We offer expedited shipping, warehousing solutions, refrigerated trucking, freight visibility, and much more! No matter whether you're seeking Otay Mesa cross bording shipping or you plan to cross the border at another port, R+L Global Logistics is prepared to be your strategic partner. 

If you’re ready to ship medical devices from Mexico, contact us today for a quote!

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