Mexico Extends Medical Device Registration Renewals to 10 Years Under 2026 General Health Law Reform
Mexico’s General Health Law reform, published on 15 January 2026, updates Article 376 to allow medical device sanitary registration renewals for up to 10 years. Initial registrations remain valid for five years, but timely renewal requests and strict compliance are required to avoid cancellation by COFEPRIS. The change impacts long-term regulatory planning for medical device manufacturers in Mexico.
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:
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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