Which X-ray designs México allows
Among medical imaging equipment in México, X-ray has design limits: only certain designs can be purchased. Radiography and mobile units need high-frequency generators, and CT must be multislice. Mammography units must be built for the job, and direct fluoroscopy is banned. Every X-ray import also needs an import permit from COFEPRIS, the health regulator. The import file for every X-ray unit includes compliance proofs signed under oath by the importer; for rebuilt or donated units, these are notarised and legalised at a Mexican consulate.
We're MediGear. Our company is registered in England and Wales, and we work as a medical equipment distributor, preparing quotes and documents and arranging freight for healthcare buyers in more than 80 countries. For healthcare in México, we look for verified makers whose models meet NOM-229 and can go through your registration holder. Your engineers and buying team get the quote with the points below already worked through. To ask for a quote, use the buyers page; there is nothing to register.
IMSS, federal institutes and private hospitals in México
Our quotes go to IMSS, federal institutes and private hospitals:
- IMSS high-speciality units such as CMN Siglo XXI and La Raza in México City, CMN de Occidente in Guadalajara and Hospital No. 25 in Monterrey
- New IMSS hospitals, such as HGR No. 23 in Ensenada, with a CT room and an MRI unit, due by the end of 2026
- IMSS-Bienestar, which gives free care to people without social security in 23 states
- Private groups such as Hospital Angeles, with 27 hospitals, and CHRISTUS MUGUERZA, and imaging centres
- Federal institutes for health care in México City, such as Hospital General de México and the national cardiology institute
- Charities that import donated units under a COFEPRIS permit, which bars resale
- Registration holders and distributors, including laboratory equipment suppliers in México
México public hospitals buy under a new procurement law of April 2025, and tenders run on a federal digital platform known as Compras MX. International open tenders admit foreign bidders as well as Mexican ones. A private clinic with one ultrasound unit to replace needs only a clear quote and a registration holder.
COFEPRIS, the registro sanitario and Spanish labels
COFEPRIS regulates devices under the General Health Law and its rules on health supplies. Devices fall into Classes I, II and III, and an imported device needs a sanitary registration. The maker's letter of representation gives a company in México the right to sell and distribute it, and that company's legal representative must be based in México. Each Mexican distributor needs its own letter. A CE certificate from an EU notified body counts as proof of good manufacturing in the file.
Buyers can check registrations in COFEPRIS's public register by number, name, class or holder. Labels must be in Spanish and show the registration number and the importer's name and address. A Spanish counter-label may be added in México after customs clearance. We are not a Mexican registration holder or importer and give no regulatory advice, so the registration stays with your Mexican partner.
NOM-229, the licencia sanitaria and yearly tests
Diagnostic X-ray sites work under NOM-229-SSA1-2002, which a 2024 review kept in force. Each site needs a health licence, the licencia sanitaria, with a permit of use and possession for each unit. The person in charge of operations and the radiation safety adviser each need a permit as well. Room shielding is based on a written analysis signed by the adviser. Wall shielding is at least 2.1 m high, and every installation gets a shielding check.
After installation, an acceptance test programme is run, and equipment that fails the standard must not be accepted. Tube voltage, exposure time, output, and linearity are tested at least once a year, and the focal spot is tested at acceptance and with each new tube. The licence holder also sends the health authority a yearly report with staff doses, and the site keeps the purchase specification and test results for the life of the unit.
127 V, 60 Hz and Spanish manuals
Four answers come from the maker first:
- 127 V and 60 Hz. México runs on 127 V at 60 Hz with type A and B plugs, so a unit built for 230 V and 50 Hz needs a different build.
- Spanish manuals. Imported X-ray systems in México must come with manuals in Spanish, parts labelled in Spanish and a copy of the registration.
- Spares. Tubes, probes and filters wear out, and spare parts and consumables can go on the same order.
- Fitting record. The installer signs a record that only certified parts were fitted, and the site keeps it with its quality papers.
Open points go to the maker in writing, because NOM-229 also sets which designs can be bought at all. If a design is not on that list, our reply says so, and you can ask us for another model.
The pedimento, ANAM and NOM-144 wood
The importer sends a pedimento (the import declaration) through the electronic customs system under the Customs Law, last changed in November 2025. It includes data from the invoice, transport papers, proof that other import rules are met, and origin papers. Every order carries:
- Invoice and packing list, with data for the pedimento
- The transport document: bill of lading or air waybill
- Origin papers
- Spanish labels, or the text for a counter-label
- Your COFEPRIS permit details, for X-ray units
Wood packaging must meet NOM-144-SEMARNAT-2017, México's ISPM 15 standard. It names the accepted treatments, and the mark goes on two opposite sides, with no stickers. PROFEPA checks the mark where goods enter, and wood that fails is treated or sent back abroad. We found no declaration or plant health certificate required for the crates themselves.
Veracruz, the Pacific ports and AIFA
- Details first. Email the model, quantity, and site, or use the RFQ form, and include your registration holder's name.
- NOM-229 check. Catalogue quotes usually follow within 48 hours and say whether the design is one NOM-229 allows.
- Approval. Nothing is ordered until you approve the quote in writing.
- Both coasts or AIFA. Sea freight into Veracruz on the east coast, or Manzanillo and Lázaro Cárdenas on the Pacific coast, or air freight into AIFA, the Felipe Ángeles Airport near México City.
Our part of the delivery finishes at the port or airport you nominate. There, your customs agent files the pedimento, and the last leg is yours. For a site far inland or on a peninsula, tell us early so the last leg can be planned.
Single units, donations and rebuilt X-ray
One autoclave for a clinic in Puebla is a normal order, quoted like any other, and X-ray detectors for a room you already have are quoted with the NOM-229 checks above. For new hospitals, see government tender for IMSS-style tenders, and neonatal units can browse Women, Children and Neonatal. Our refurbished range covers pre-owned units, and México allows refurbished medical devices with conditions. Importers of used equipment keep a log with one page per device, showing the import permit, function tests, buyer and warranty. Every X-ray unit needs an import permit with sworn compliance proofs, and rebuilt or donated units need them notarised and legalised at the consulate. NOM-229 also excludes single-slice CT, direct fluoroscopy, and converted mammography units.
Disclaimer
Use this page as general information about buying for México. Supply offers and legal, regulatory or customs advice are outside its scope. What we can quote depends on the maker, and we treat an order as placed only after both sides put it in writing. Devices require COFEPRIS registration and Spanish labels, and X-ray units require an import permit and a health licence. Your registration holder and customs agent handle clearance and the regulatory side, as we are not a Mexican importer or registration holder.
Will it run on 127 V and 60 Hz?
Mexico's mains supply is 127 V at 60 Hz, so a unit built for Europe usually needs a different build. Send the model number and the site, ideally with a data sheet, and we'll quote with the certificates, the Spanish manuals and the route.
Frequently Asked Questions
Send the model number or a data sheet to connect@medigear.uk or via the RFQ form; no account is needed. We also quote models first seen at medical equipment trade shows in Mexico. We quote for IMSS, federal institutes, private groups and Mexican medical device suppliers. Your team can weigh our reply against its hospital buying criteria for medical devices.
An imported device needs a sanitary registration. A company in Mexico holds it, using the maker's letter of representation. Import without a registration is possible only in limited cases, such as research or a health emergency, and buyers can check registrations in COFEPRIS's public register.
Yes. Label content must be in Spanish, though other languages may appear too, and a Spanish counter-label may be added in Mexico after customs clearance. The label shows the registration number and the importer's name and address, and we check the maker's labels against this before quoting.
For a Mexico X-ray machine, NOM-229 allows radiography and mobile units with high-frequency generators, multislice CT and purpose-built mammography units, and it bans direct fluoroscopy. Every X-ray import also needs a COFEPRIS sanitary import permit, and the site needs a licencia sanitaria.
Yes. Manzanillo and Lázaro Cárdenas are on the Pacific coast, and Veracruz is on the east coast, and smaller items can fly into AIFA near Mexico City. Our part of the medical equipment supply ends at the port or airport you nominate, and your agent takes it from there.
Data from the commercial invoice, transport documents, proof that other import rules (such as the COFEPRIS permit) are met, and origin documents, transmitted electronically by the importer. From our side, we provide the invoice, packing list, origin papers, and the model's certificates.
No. Mexico healthcare products are quoted as single units on most catalogue lines, and the same goes for Mexico refurbished medical equipment. If a maker sets a minimum order, our first reply says so. The unit still needs its registration through a Mexican holder, which we confirm before quoting.
Usually the paperwork: a missing registration, the X-ray import permit, sworn compliance proofs, or, for a remanufactured unit, consular legalisation. Stock, the sea leg and the last leg matter too, and the quote states the lead time and route. If Mexico hospital equipment is bound far inland, tell us early to plan the last leg.