Aviso de Funcionamiento and Licencia Sanitaria: Facility Requirements in Mexico

1. Key takeaways

Mexico regulates facilities and products along two separate tracks. Products require a health registration (Registro Sanitario), while premises where regulated activities are carried out must submit an operating notice (Aviso de funcionamiento). The exception concerns facilities engaged in the processing of medical radioactive sources: those premises do not fall under the operating notice regime and must instead obtain a sanitary licence (Licencia sanitaria) issued in coordination with the National Commission on Nuclear Safety and Safeguards (CNSNS). Understanding this two-track structure matters because product registration and facility obligations run in parallel, on separate timelines, and a delay on either line can hold up a market entry plan even when the other line is complete. The distinction also determines which authority interactions apply to which part of the project, and it shapes how importers, distributors and manufacturers divide compliance work among themselves.

• Products require a health registration; facilities conducting regulated activities must submit an operating notice.
• Premises processing medical radioactive sources are excepted and require a sanitary licence coordinated with the CNSNS.
• The operating notice is a filing-type action that runs in parallel with product registration; it is not part of the registration.
• Each facility is handled according to its activity, and there is no single notice that covers all sites nationwide.
• Importers also need an operating notice and a Responsible Sanitary Officer, including for products exempted under Annex II of the 2025 agreement.

2. Legal basis

The facility regime rests on the medical inputs regulation as amended in 2026, supported by the site and system standards and the 2025 low-risk agreement. Together these instruments define when an operating notice is required, when the sanitary licence exception applies, and what importers must maintain even where product-level requirements are relaxed. Read together, they make clear that facility compliance is a standing obligation attached to the activity, not to the product file.

3. Expert insights

Insight one: the operating notice is a filing-type action taken in advance. The wording of Article 82 of the RIS is that a facility must submit an operating notice (aviso de funcionamiento). This runs in parallel with the health registration of the product; it is not part of the registration. The practical consequence is scheduling: the two obligations have different triggers, different documentation and different processing behaviour, and treating them as one combined project line invites avoidable delay.

Insight two: radioactive sources are a clearly defined exception. Premises housing devices that contain radioactive sources, such as X-ray equipment, do not fall under the operating notice regime. They must instead obtain a licence issued in coordination with the CNSNS. In addition, such products also require a separate CNSNS import licence. Companies entering this space should map both the facility-side licence and the import-side permission early, because both involve a coordinator outside the ordinary COFEPRIS track. Waiting until the equipment is ordered or shipped to discover the exception is the most expensive way to learn it exists.

Insight three: importers also need an operating notice. Devices listed in Annex II of the 2025 agreement are exempt from the health registration and from the import permit, but the importer must still hold an operating notice and must have a Responsible Sanitary Officer (Responsable Sanitario) in place. Exemption at the product level therefore does not mean exemption at the facility level, and importer onboarding should include verification of both elements before the first shipment.

Insight four: multiple facilities must each be handled separately. Manufacturing, warehousing and distribution sites are each handled according to the activity they perform. There is no single notice that covers every site nationwide. Companies operating through several locations should plan for per-site filings and keep a consolidated ledger of which site holds which authorisation, so that expansion or relocation does not leave any activity undocumented.

Insight five: the facility regime is interlocked with the quality system standard. NOM-241-SSA1-2025 covers design, development, manufacturing, storage (including conditioning and warehousing) and distribution. The compliance status of a facility directly affects the assessment of conformity with the quality system. A site deficiency can therefore have consequences well beyond the site itself, reaching the system-level evaluation that supports the product registration. This interlock is a further reason to keep facility documentation current rather than treating it as a one-time filing exercise.

4. Practical recommendations

• At project start, separate the product registration and the facility operating notice into two parallel workstreams, each with its own schedule, owner and documentation set, so neither line waits unnecessarily on the other.
• Identify radioactive-source products early and reserve time for the CNSNS-coordinated process on both the facility licence and the import licence side.
• For multi-site operations, complete the filings site by site according to each activity type and maintain a ledger of facility authorisations as part of routine compliance administration.
• Build the importer’s operating notice and Responsible Sanitary Officer arrangement into supplier qualification criteria, so that channel partners are verified before products move.
• Treat facility changes such as relocation or the addition of a warehouse as changes handled under the amendment approach, and do not continue relying on an old notice that no longer reflects the site, since a mismatch between the notice and actual operations is exactly what a verification visit will surface first.

5. Verification checklist

• □ Product registration and facility operating notice are scheduled on separate tracks
• □ Radioactive-source involvement has been identified (if so, the CNSNS licence route applies)
• □ Each facility has been handled according to its activity type
• □ The importer’s operating notice and Responsible Sanitary Officer have been confirmed
• □ Facility changes have been handled under the amendment approach

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