Mexico Extends Medical Device Registration Renewals to 10 Years Under 2026 General Health Law Reform

Mexico published a reform to the General Health Law on 15 January 2026, introducing an important change affecting medical device registration in Mexico. The most significant update appears in Article 376, which confirms that while the first sanitary registration remains valid for five years, subsequent renewals may now be granted for periods of up to ten years. This change directly impacts regulatory strategy and lifecycle planning for medical device manufacturers working with COFEPRIS.

As a company supporting medical device registration and regulatory compliance in Mexico, this reform creates both opportunities and new compliance considerations for manufacturers and marketing authorization holders.

What Article 376 Means for Medical Device Registration in Mexico

Article 376 reaffirms that medical devices require sanitary registration in Mexico, except for those determined by the health authority to be low risk and exempt from registration.

Sanitary registration is granted exclusively by the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and remains a prerequisite for legal commercialization in the Mexican market.

Extension of Registration Validity: Key Change in 2026

Under the 2026 reform:

• The initial medical device sanitary registration remains valid for five years

• Registrations may be renewed for up to ten years

• Renewal must be requested by the interested party and meet regulatory requirements defined by COFEPRIS

This extended renewal period reduces the frequency of renewals but places greater importance on maintaining compliance throughout the product lifecycle.

When COFEPRIS May Cancel a Medical Device Registration

The reform reinforces scenarios where COFEPRIS may cancel a sanitary registration, including:

• Failure to request a renewal within the required timeframe

• Unauthorized changes to the medical device

• Changes to raw material manufacturers without prior approval

From a regulatory standpoint, cancellation is treated as a formal administrative procedure, emphasizing the need for proactive lifecycle and change-management controls.

What Manufacturers Should Do Now

For medical device companies operating in Mexico, this reform highlights the need for a long-term regulatory strategy. Recommended actions include:

• Reviewing current registration timelines and renewal eligibility

• Assessing product change histories for compliance risks

• Preparing documentation aligned with extended renewal cycles

• Monitoring upcoming COFEPRIS secondary regulations

Early preparation ensures manufacturers can fully benefit from the 10-year renewal option without risking compliance gaps.

How We Support Medical Device Registration in Mexico

We assist medical device manufacturers with:

• COFEPRIS medical device registration and renewals

• Regulatory classification and exemption assessments

• Change management and post-market compliance

• Ongoing regulatory monitoring and lifecycle support

With the updated General Health Law, our role is to help clients navigate longer registration cycles while maintaining full regulatory compliance.

Official Publication of the Reform

The General Health Law reform, including Article 376, was published in the Diario Oficial de la Federación (DOF) on 15 January 2026. Read the official DOF publication of the General Health Law reform (PDF).

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