The 2025 Low-Risk Agreement and Its Three Annexes

1. Key takeaways

The agreement on low-risk and non-regulated medical devices published in DOF 2025-07-15 reorganizes the regulatory path for low-risk products through three annexes: Annex I lists 93 items of low-risk devices that still require sanitary registration; Annex II lists 104 items of low-risk devices that are exempt from sanitary registration (but must still comply with GMP and technovigilance); and Annex III lists 1,984 items of products that are not considered health supplies and fall outside COFEPRIS device regulation. The agreement replaced the two older agreements of 2011-12-31 and 2014-12-22. The redistribution is significant in both directions: some products lost an exemption they had relied on, and many products previously sitting in a gray zone now have a clear answer. Because the annex lists are item-based, the starting point for every portfolio review is to locate each product on the correct annex before making any filing decision, since the annex determines not only whether registration is needed but also what supporting obligations and border declarations apply.

2. Legal basis

The instruments behind the new framework, including the repealed predecessors and the standards that continue to bind exempt products, are set out below.

The persistence of NOM-241 and NOM-240 obligations for Annex II products is the detail most often missed. Exemption from registration removes one layer of obligations; it does not remove the manufacturing standard or the vigilance framework that apply to the products as devices on the market.

A second point of caution is the dating of the agreement itself. Because practical sources record slightly different signing and release dates around the DOF publication, projects should anchor all deadlines to the published date in the DOF and note the discrepancy in the compliance file. Transition calculations, exemption expiry and phase submissions all hang off that date, so an incorrect anchor would shift the whole calendar silently. Recording the DOF reference once, in a place every team member can see, prevents duplicate debates about which date governs.

3. Expert insights

Insight 1: Annex I carries a statutory commitment of 20 working days. For low-risk devices listed in Annex I, COFEPRIS must issue a decision within 20 working days. Deficiency requests are split into administrative deficiencies with a 10-day window and technical deficiencies with a 15-day window, and the applicant must complete corrections within 10 days. This is the most explicit time-limit commitment in this round of reform. The windows are short by international standards, which means the dossier must be genuinely ready at submission and the registration holder must be staffed to respond within days, not weeks. Planning around these windows is a competitive advantage for products on Annex I.

Insight 2: Annex II exemption from registration is not exemption from oversight. What is exempted is the sanitary registration and the import permit, but the GMP and technovigilance obligations remain. Importers must submit a declaration at the port of entry confirming that the product is on the Annex II list and complies with GMP and technovigilance requirements, and the importer must still hold the business notice and a sanitary responsible person (Responsable Sanitario). In operational terms, an Annex II product still needs a quality system behind it, a vigilance process behind it and a compliant importer in front of it. Companies that treat Annex II status as deregulation discover the gap the first time a batch is held at customs for lack of a declaration.

Insight 3: The transition is phased over three years to 2029. Products that previously sold under exemption letters and are now listed in Annex I must submit registration applications in phases between 2025 and 2028 according to their position in the list, with 2029 as the final deadline for all applications. Existing exemption letters expire 5 years after the agreement enters into force. The two clocks run differently, so a product may still hold a valid exemption letter after its own submission phase has begun; the calendar should be built from both dates rather than either one.

Insight 4: Annex III is the biggest burden reduction. The 1,984 items listed there are, by nature or intended use, expressly not considered health supplies: they need neither registration nor an import permit. Laboratory reagents, hospital furniture and cleaning agents, products that long occupied a gray zone, now have a defined place. A documented Annex III determination is itself a compliance asset, because it converts an informal assumption into a citable basis when customs or a business partner asks why no registration exists.

Insight 5: Sterile devices are excluded across the board. All sterile medical devices are considered not low-risk, and none of the reductions of this agreement applies to them.

4. Practical recommendations

1. Immediately re-verify the regulatory status of every product on sale against the three annexes, with priority for products previously sold under exemption letters.
2. Schedule Annex I filings around the 20 working days commitment, but budget for a longer cycle to absorb time lost to deficiency corrections.
3. For Annex II products, prepare a port-of-entry declaration template and a GMP and technovigilance evidence package kept ready with each shipment.
4. Manage the expiry of old exemption letters actively and back-plan the registration program from the 5-year expiry point.
5. Do not apply the low-risk track to sterile products; prepare them under the regular class system.

5. Verification checklist

• □ Annex placement confirmed (I / II / III)
• □ Annex I products scheduled against the 20 working days framework
• □ Annex II products have GMP and technovigilance evidence and the port declaration ready
• □ Old exemption letters back-planned against the 5-year expiry point
• □ Confirmed that sterile devices receive no low-risk relief
• □ Confirmed that the 2011 and 2014 agreements are no longer relied upon

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