Import Permits and VUCEM: Bringing Medical Devices into Mexico

1. Key takeaways

Holding a health registration does not by itself confer the right to import. Mexico applies a shipment-by-shipment import permit (Permiso de importación) to medical devices, declared through the foreign trade single window (VUCEM). Only the holder named on the registration, or a licensed distributor listed on the registration, may apply. Low-risk devices listed in Annex II of the 2025 agreement are exempt from the import permit, but the importer must submit a declaration at the port of entry. The distinction between the registration and the import permit is the single most common source of planning errors: companies that secure the registration and assume the commercial flow will follow often discover that the import side has its own application logic, its own platform and its own cadence tied to shipments rather than to product lifecycles.

• The health registration and the import permit are two independent authorisations, handled on separate systems: registration on DIGIPRiS, import permits on VUCEM.
• Only the holder of record or a licensed distributor listed on the registration can apply for the import permit.
• Annex II of the 2025 agreement (DOF 2025-07-15) exempts listed low-risk devices from the registration and the import permit, subject to a port declaration.
• Devices containing radioactive sources need an additional licence from the CNSNS in parallel with the ordinary import permit.
• The 1,984 product entries in Annex III are not regarded as health inputs at all and require neither registration nor an import permit.

2. Legal basis

Four sources define the import landscape: the 2025 agreement that creates the Annex II and Annex III exemptions, the regulation that ties marketing to the health registration, the VUCEM platform through which permits are declared, and the specific exception for radioactive-source processing premises. Their combined effect is summarised below.

3. Expert insights

Insight one: registration and import are two separate authorisations. The health registration answers whether the product can be sold; the import permit answers whether this particular batch can enter the country. The two sit in different systems: the registration runs on DIGIPRiS, the import permit on VUCEM. Because the platforms, application logic and timelines differ, a project plan that treats import as a by-product of registration will misjudge both the resourcing and the calendar of the import operation.

Insight two: the Annex II relief is conditional. Exemption from the import permit does not mean exemption from oversight. The importer must submit a declaration at the port confirming that the product falls within the Annex II list and complies with GMP and technical vigilance requirements, and the importer must still hold an operating notice and a Responsible Sanitary Officer. The relief changes the paperwork, not the underlying obligations, and the declaration at the port is itself a compliance act that can be checked. Importers should therefore keep the supporting evidence as current as the declaration itself.

Insight three: the applicant is restricted. Only the holder or a licensed distributor listed on the registration can apply for the import permit. This is what gives the mechanism of listing multiple importers on one registration its operational value: channels can be added at the import level without touching the registration, provided the entity is properly listed before the shipment arrives. Planning the listing in step with channel expansion keeps both the permit and the registration clean.

Insight four: products with radioactive sources carry one extra step. Devices containing radioactive sources, such as X-ray equipment, need a licence from the National Commission on Nuclear Safety and Safeguards (CNSNS) in addition to the ordinary import permit. This second permission involves a different authority and should be scheduled separately rather than assumed to move in step with the VUCEM filing.

Insight five: Annex III products fall entirely outside device regulation. The 1,984 entries listed in Annex III are not regarded as health inputs by reason of their nature or intended use; they require neither registration nor an import permit. Screening the portfolio against Annex III can therefore remove products from the registration plan altogether, provided the classification is applied as written and not stretched to fit convenient cases.

4. Practical recommendations

• Schedule import permits batch by batch, aligned with the sales rhythm, and keep that schedule separate from the registration timeline so the two are never conflated in planning or in cost forecasts.
• For Annex II products, prepare the port declaration template in advance and retain GMP and technical vigilance evidence that travels with the goods and is available for inspection on request.
• When adding a new channel, handle it through listing on the registration rather than through a separate registration for each distributor, keeping the certificate stable while the channel evolves.
• For products containing radioactive sources, reserve lead time for the CNSNS licence early in the project, since it runs in parallel with, not after, the ordinary import permit.
• Screen the product line against the Annex III list and remove products outside device regulation from the registration plan, documenting the screening decision for each item.

5. Verification checklist

• □ The registration and the import permit are scheduled on separate tracks
• □ The applicant is the holder or a distributor listed on the registration
• □ For Annex II products, the port declaration and GMP / vigilance evidence are prepared
• □ The CNSNS permit is scheduled for products containing radioactive sources
• □ Annex III products have been removed from the registration plan

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Mexican market. Our team manages COFEPRIS registrations and equivalence (equivalencia) reviews, coordinates third-party authorised centre routes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com