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Customs··7 min read

Importing Ventilators, Oxygen Concentrators and Masks into Mexico Fast

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During the COVID-19 emergency, hospitals, governments and distributors needed ventilators, oxygen concentrators and masks in days, not months. At Kold Gold we moved that kind of equipment: ventilators, oxygenators, masks and other medical equipment. We learned that with critical cargo, speed doesn't depend only on the aircraft but on having the health file ready before it takes off.

This guide focuses on emergency and high-demand equipment. For the general picture of risk classes, licenses and the sanitary officer, see our guide to importing medical equipment into Mexico: COFEPRIS permits and NOMs (in Spanish).

Regulatory information verified as of October 1, 2026.

Why does critical equipment get stuck at customs?

  • No sanitary registration for the exact model, or the registration belongs to another company.
  • The importer can't show the permit or health authorization required for the tariff line.
  • The label isn't in Spanish or lacks the information the standard requires.
  • Lithium batteries or cylinders weren't declared as dangerous goods and the airline rejects the cargo.
  • The technical description doesn't match across invoice, packing list and health file.

In an emergency, each of these costs days. Almost all of them can be solved before shipping.

There is also a timing trap: in a crisis, demand spikes everywhere at once. Air capacity tightens, suppliers substitute models and paperwork arrives in pieces. A replacement model that looks identical may not be covered by the sanitary registration you already have, so every substitution should be checked against the file before it is accepted and loaded.

What does the law require to import a ventilator or an oxygen concentrator?

Mexico's General Health Law defines medical equipment as devices, accessories and instruments for specific use in medical care (Article 262). Its Article 376 states that medical devices require sanitary registration (registro sanitario), except low-risk ones the authority exempts; the registration is valid for five years and can be extended.

In addition, the Health Ministry agreement listing the goods subject to its regulation on import and export (DOF, December 26, 2020) provides that, depending on the tariff line, the importer must present the prior sanitary import authorization or a copy of the sanitary registration. It includes exceptions, such as donations, scientific research or exhibitions, which are reviewed case by case.

Ventilators and respiratory support equipment usually sit in higher risk classes because of what they do. Confirm the class of the exact model with your sanitary officer (responsable sanitario): the file and the processing time depend on it.

Key point. Customs reviews what the entry declares. If the tariff line requires a permit or registration and it isn't shown, the goods won't be released, even with a hospital waiting for them.

Do masks need sanitary registration too?

Yes. On July 7, 2025, Mexico's Official Gazette published the lists of low-risk medical devices that require sanitary registration, those that don't, and products not considered health supplies. The first list includes, among others:

  • Face masks (cubrebocas).
  • Non-sterile surgical masks.
  • Folding, shell or cup-type respirators (N95).

Being low-risk doesn't mean being exempt: they require sanitary registration. By contrast, items such as mechanical beds or wheelchairs appear on the list of devices that don't require registration, although they must meet other obligations.

What happened to permits during the COVID-19 emergency?

In April 2020, COFEPRIS published temporary provisions to ease the acquisition and manufacturing of ventilators during the emergency, drawing on experience gathered by WHO and PAHO. Those measures were valid only for the duration of the health emergency.

Today the ordinary regime applies. If a new emergency were declared, authorities could publish extraordinary measures, but planning an import around them is not advisable. COFEPRIS has also published abbreviated pathways and equivalence schemes for devices already approved by certain reference regulators; their scope and validity change, so confirm them with your sanitary officer before filing.

What does the labeling standard say?

NOM-137-SSA1-2008, Labeling of medical devices, published December 12, 2008, is listed as in force by Mexico's Ministry of Economy (its 2023 systematic review recommended modifying it). In practice: information in Spanish, manufacturer and importer details, batch or serial number and the statements that apply to the device type. If the equipment arrives with English-only labels, relabeling must be planned in advance.

How do you move critical equipment in a hurry?

By air. It's the natural route for critical equipment: urgent cargo on passenger or freighter flights and, when volume or deadline justify it, charter flights. See our air freight options.

Lithium batteries. Many portable ventilators and oxygen concentrators carry lithium-ion batteries. For air transport, IATA's guidance distinguishes batteries packed with equipment (packing instruction 966) and contained in equipment (967). Since January 1, 2026, lithium-ion batteries packed with equipment must be offered at a reduced state of charge (no more than 30%); for batteries contained in equipment it's a recommendation.

Oxygen cylinders. Compressed oxygen is a dangerous good with strict packaging, quantity and acceptance rules. A concentrator doesn't carry compressed oxygen, but its batteries may still be regulated.

By sea. For inventory replenishment, hospital furniture or large volumes of consumables, ocean freight lowers cost when the deadline allows.

What can be prepared before the aircraft departs?

What to prepareWhy
Sanitary registration for the exact modelWithout it, the tariff line won't clear
Confirmed tariff classificationIt defines which permits customs requires
Spec sheets and manuals in SpanishFor the file and the labeling
Battery or dangerous goods declarationSo the airline accepts the cargo
Invoice and packing list with serial numbersSo everything matches the file
Sanitary officer and importer detailsTo answer any authority request

Who can be the importer?

In an emergency it's tempting to let "whoever has the money" import, but the health file doesn't work that way. The sanitary registration is held by a registration holder, the importer must have the health authorizations that apply to its establishment, and there must be a sanitary officer accountable to the authority. If the end buyer (a hospital, an agency or a new distributor) doesn't meet those requirements, the usual option is to import through a company that does, such as the registration holder's distributor. Settling this before paying the supplier saves weeks.

What if the equipment is a donation?

Donations of health supplies have their own treatment under import health rules, but that doesn't mean they enter without paperwork: they still need documents showing origin, recipient and condition, and used or refurbished equipment may face additional requirements. Confirm the applicable case with your sanitary officer before shipping, especially if equipment comes from several donors.

Common mistakes in emergency imports

  • Buying from a new supplier without confirming the model is registered in Mexico.
  • Assuming urgency waives permits. Outside a published extraordinary measure, it doesn't.
  • Not declaring batteries and missing the flight.
  • Shipping equipment without serial numbers on the invoice when the file requires them.

Checklist before shipping

  1. Confirm the sanitary registration for the exact model and who holds it.
  2. Classify each device and check which permits its tariff line requires.
  3. Define the importer and its sanitary officer.
  4. Declare batteries and gases under the airline's rules.
  5. Review labels and manuals in Spanish.
  6. Book the flight only when the file is ready.

How we handle it at Kold Gold

  • Advance review of tariff classification, sanitary registration and permits with your sanitary officer.
  • Urgent or charter air freight, with battery and dangerous goods declarations.
  • Customs brokerage and COFEPRIS filings coordinated in parallel at any Mexican customs office.
  • Pickup at origin with inspection of quantity, serial numbers and labeling, and delivery to the hospital or warehouse.

We operate in the world's busiest international ports and at every customs office in Mexico. We speak your language: multilingual agents who coordinate with manufacturers, authorities and hospitals.

Explore our medical equipment logistics service, see our track record or get a quote with our freight quote tool. Message us on WhatsApp or call +52 55 8897 4255 (Mexico) or +1 (619) 359-6567 (United States). You can also email direccion@kold.gold.

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