Prorroga Renewal in Mexico: the 150-Day Deadline and 10-Year Terms

1. Key takeaways

The renewal (Prórroga) of a Mexican health registration must be submitted no fewer than 150 calendar days before the validity period expires. The validity structure was adjusted by the LGS amendment decree of DOF 2026-01-15: first registrations run for 5 years, and subsequent renewals can reach 10 years. However, the RIS amendment decree (DOF 2026-04-24), in Article 190 Bis 3, currently limits the 10-year first renewal to devices manufactured in Mexico; foreign-manufactured devices are not yet covered. For imported products this means the 5-year structure remains the planning basis for now, and teams should track whether the regulation is later extended to cover foreign manufacture before changing any renewal calendar.

• Renewal must be filed no fewer than 150 calendar days before expiry; there is no grace period, and a lapse means re-registration and new fees.
• The validity structure is: first registration 5 years; subsequent renewals up to 10 years (LGS, DOF 2026-01-15).
• The 10-year first renewal currently applies only to domestically manufactured devices (RIS Article 190 Bis 3).
• Renewal filings are supported by fee payment, a copy of the current registration and the technical vigilance report; imported devices additionally need the manufacturer’s GMP certificate or equivalent.
• A timely renewal keeps the registration valid while COFEPRIS decides, providing an important scheduling buffer.

2. Legal basis

The renewal regime combines the statutory validity framework of the General Health Law, the operational detail added by the 2026 RIS amendment, the vigilance reporting requirement of the device standard, and the fee rule of the Federal Rights Law. The table below consolidates the four sources and what each contributes.

3. Expert insights

Insight one: 150 calendar days is a hard node. Article 190 Bis 7 of the RIS requires the second and subsequent renewal applications to be filed no fewer than 150 calendar days before the validity period expires. Missing the date offers no grace period: a lapsed registration means re-registering and paying the fees again from the beginning. The node should therefore be treated as a fixed deadline in the compliance calendar, with internal checkpoints well ahead of it rather than work compressed into the final weeks.

Insight two: the 10-year term currently covers domestic manufacture only. Article 376 of the LGS establishes the legal space for a 10-year term, but the wording of Article 190 Bis 3 of the RIS amendment addresses devices manufactured in Mexico. Official communication indicates that the amendment decree does not yet include foreign-manufactured devices, with coverage expected to be added in the coming months. For imports, planning on the 5-year structure remains the more prudent basis until the regulation is extended.

Insight three: renewal documentation has been substantially simplified. Under the current approach, the renewal of a device registration centres on payment of the official fee, a copy of the current registration certificate, and the technical vigilance report; for imported devices, the manufacturer’s GMP certificate or an equivalent document is additionally required. The simplification reduces the assembly burden, but it also raises the premium on keeping the vigilance report and GMP evidence ready at all times, since they are the documents the renewal will actually turn on.

Insight four: a timely renewal keeps the registration valid. Until COFEPRIS issues its decision, a renewal filed on time maintains the registration in a valid state. This is an important scheduling buffer: continuity of legal status depends on the timeliness of the filing, not on the speed of the decision, which in turn means the internal deadline that matters is the filing date, not the approval date.

Insight five: transitional arrangements are judged by the filing date. The transitional provisions of the RIS amendment decree state that registration or renewal applications submitted before its entry into force are processed under the rules in force at the time of original submission until the case is closed. Projects already under way do not need to change their approach to comply with the new rules, and that certainty should be recorded in the project file to prevent unnecessary rework.

4. Practical recommendations

• Set the renewal reminder 18 months before the expiry date, leaving preparation time for the technical vigilance report, the GMP evidence and the letter of authorisation from the manufacturer.
• Schedule imported products on the 5-year structure while tracking whether the RIS later adds provisions covering foreign-manufactured devices.
• Assemble the renewal package around its four components: the payment receipt, the copy of the registration certificate, the technical vigilance report, and the GMP certificate or equivalent document.
• Budget the renewal fee at the 75% tier of the registration fee.
• Handle projects already in progress under the rules in force at submission, without adjusting them to the new regime mid-course.

5. Verification checklist

• □ The renewal reminder is set 18 months before expiry
• □ The filing date satisfies the 150 calendar days requirement before expiry
• □ The four components of the renewal package are complete
• □ The fee is budgeted at the 75% tier
• □ The difference in terms between domestic and foreign manufacture has been confirmed
• □ Projects in progress are handled under the original rules

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