Skip to main content

Low-Risk Devices — Annexes 1, 2 & 3

The July 7, 2025 COFEPRIS decree (published in the Diario Oficial de la Federación) substantially revised Mexico's classification framework for low-risk medical devices. It formally repealed the exemption agreements of 2011 and 2014 and introduced a new three-Annex structure.

Why this matters​

Prior to 2025, many low-risk device manufacturers operated under an informal "exemption letter" system. The new Annex framework:

  • Provides greater regulatory clarity and consistency.
  • Exempts a broader set of devices from registration (Annex 2).
  • Creates explicit exclusions from health supply regulation (Annex 3).
  • Introduces a staggered transition for devices that now require registration.

Annex 1 — Low-risk devices requiring registration​

Annex 1 lists low-risk medical devices that continue to require sanitary registration from COFEPRIS. However, the application process has been streamlined:

  • Domestic manufacturers: operating licence, draft labelling, technical information, proof of fee payment.
  • Foreign manufacturers (importers): as above, plus a letter of representation from the MRH.
  • Review target: COFEPRIS has committed to resolving these applications within 20 business days.

Devices that were previously marketed under an exemption letter but are now listed in Annex 1 must apply for formal sanitary registration within the staggered transition period (up to 3 years, organised by position in the Annex 1 list).

Annex 2 — Devices exempt from registration​

Annex 2 identifies low-risk devices that are no longer subject to sanitary registration for manufacture or commercialisation. This also eliminates the import permit requirement.

Exempt ≠ unregulated

Devices in Annex 2 are still subject to GMP requirements (NOM-241) and technovigilance obligations. Exemption from registration does not mean exemption from oversight. Manufacturers must be prepared to demonstrate compliance.

Annex 3 — Products not classified as health supplies​

Annex 3 lists products that are not health supplies at all — they fall entirely outside COFEPRIS medical device jurisdiction and require no sanitary registration or import permit.

Examples typically in this category:

  • General-purpose laboratory reagents (not for clinical diagnosis)
  • Hospital furniture (beds, trolleys, cabinets)
  • General cleaning and disinfection agents
  • Laboratory glassware and consumables (non-diagnostic)

How to use the Annexes​

  1. Identify your product type.
  2. Search the relevant Annex in the July 2025 DOF decree text.
  3. If listed in Annex 2 or 3 → no registration required (but GMP/TV still apply for Annex 2).
  4. If listed in Annex 1 → apply for streamlined registration via DIGIPRiS.
  5. If not listed in any Annex → apply for full Class I/II/III registration.
Check current Annex text

COFEPRIS may update the Annexes over time. Always verify against the most current DOF text. Links are available in Resources → Useful links.

Check current Annex text: The complete Annex lists are published in the July 7, 2025 DOF decree (full title: Acuerdo por el que se establecen los requisitos para obtener el registro de sanidad de insumos para la salud, dispositivos médicos y productos sanitarios). Access the DOF directly at www.dof.gob.mx or via the COFEPRIS Useful Links page. Use the DOF search function to locate your device type in the relevant Annex. If your device is not explicitly listed, consult COFEPRIS for classification.