Homoclave COFEPRIS-04-060 and COFEPRIS-04-070 Explained

1. Key takeaways

Since the agreement published in DOF 2025-08-22, Mexico has consolidated the multiple registration application items that were previously split by manufacturing origin, namely domestic manufacturing, importation and third-party manufacturing, into two homoclaves: COFEPRIS-04-060 for the health registration of medical devices under the regular pathway, and COFEPRIS-04-070 for the health registration of low-risk medical devices. Which code applies is decided by a single question: whether the product appears on the Annex I low-risk list of the 2025 agreement. The consolidation matters for every applicant because the homoclave is the unique identifier of the application item; it appears on the forms, on the fee payment and at the intake window, and an incorrect selection stalls the application before the technical review even begins. The code is also what the authority’s tracking system indexes, so downstream correspondence follows whichever code was chosen. This page explains what the consolidation changed, how the code choice is made, how the closure of the old equivalence pathway connects to the same reform, and why the code and the pathway remain two independent dimensions of the same filing. Reading them as a single merged decision is the most common source of intake-stage errors, so the distinction is worth fixing in the team’s vocabulary before the first filing.

2. Legal basis

Three instruments define the framework: the homoclave agreement that merged the application items, the 2025 low-risk agreement whose Annex I determines which products take the low-risk code, and the abbreviated pathway guidelines that operate on a separate axis. The table below lists each instrument with its date and the operational point it establishes.

3. Expert insights

Insight 1: what was merged is the manufacturing-origin dimension. In the past, domestically manufactured devices, imported devices and third-party manufactured devices each followed a different application code. Under the new framework, products within the same risk tier are covered by a single code regardless of origin. For companies with multi-origin supply, meaning the same product made at more than one site or sourced from more than one manufacturing arrangement, the filing logic becomes simpler: one code per risk tier instead of a matrix of origin-based variants. The consolidation removes an entire axis of possible filing mistakes that the old framework created.

Insight 2: the code choice follows the risk classification. Products on the low-risk list take 04-070; everything else takes 04-060. The deciding reference is the item number in Annex I of the 2025 agreement, not the company’s own perception of how risky the product is. A device that the manufacturer regards as simple does not take the low-risk code unless its item appears on the list, and a device that appears on the list takes that code even if the company would have preferred the regular track. The mapping from item number to code should therefore be documented, not carried in anyone’s memory.

Insight 3: the old equivalence pathway was closed together with the code adjustment. Under the same round of reform, from 2025-10-06 onward, applications based on the former equivalence arrangements with the FDA, Health Canada and other authorities are no longer accepted. The closure and the code switch are complementary parts of one package, which is why dossiers must be updated on both fronts at the same time: new codes, and no reliance on the retired equivalence basis.

Insight 4: a code is not a pathway. The abbreviated pathway (Vía Abreviada) is governed by its own guidelines and stands on a separate dimension from the homoclave. A product on the low-risk list may simultaneously qualify for the 04-070 code and for the summary documentation of the abbreviated pathway, and the two eligibility questions must each be assessed on their own terms. Collapsing them into a single judgment is a recurring analytical error, and it is avoided simply by asking the two questions in two separate sections of the filing plan, each with its own evidence.

Insight 5: a wrong code stalls the application at the intake stage. The homoclave is the unique identifier of the application item, and a mismatch means the application is either not accepted or must be refiled. The cost is concrete: one fee payment and one queue position are spent on an attempt that never reaches a reviewer. Checking the code is therefore among the cheapest verifications in the entire process and among the most consequential, because everything downstream, from the fee receipt to the intake confirmation, inherits whatever code was written at the start.

4. Practical recommendations

• Before submission, determine the homoclave using a mapping from the Annex I item number to the code, and record that determination in the filing checklist.
• For the same product supplied from multiple origins, consolidate under a single code according to the risk tier, without splitting by origin as the previous framework allowed.
• For all filings after October 2025, use the new codes exclusively and do not cite the retired equivalence pathway codes.
• Assess the applicability of the abbreviated pathway and the selection of the code separately, and document the two assessments in different sections of the filing plan.
• Keep the code printed on the fee payment receipt identical to the code used in the application, so that the intake window does not find a mismatch.

5. Verification checklist

• □ Confirmed whether the product falls under Annex I of the 2025 agreement
• □ The homoclave has been determined (04-060 or 04-070)
• □ Multi-origin supply has been consolidated under a single code
• □ The old equivalence codes closed before 2025-10-06 are not in use
• □ The abbreviated pathway applicability and the code selection have been assessed separately
• □ The code on the fee payment receipt matches the application code

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