Mexico’s General Health Law Amended: Renewal Registration, Validity Extended

By Evan Ruby, Pedro Omar Sánchez Neri and Evangeline Loh

Background

On January 15, a decree was promulgated to amend the General Health Law (Ley General de Salud) for all health products in Mexico. The decree amended, added, and repealed several provisions, taking effect on January 16, one day after its publication in the Official Gazette (Diario Oficial de la Federación). 

This reform includes considerations for the authorization of health supplies during public health emergencies, incentives for government procurement tied to domestic investment, adoption of new information technologies within the public health context, and regulation of e-cigarettes and vaping products, among other topics. 

Provisions that impact medical devices

Emergo by UL experts have assessed the decree and identified three provisions related to medical devices which may be of particular interest: Article 262.2, Article 376, and Article 396(l). 

Article 262.2 is expected and emphasizes the importance of post-market surveillance (PMS), including active monitoring of the performance of a device once it is on the market. Technovigilance is introduced as a concept within this major regulation for the first time, and Article 262.2 states that these activities must commence immediately after COFEPRIS issues a medical device registration. 

Article 396(I) expands verification activities from only physical visits to also include documentary or electronic means.  

Lastly, Article 376 states that the validity of registration renewals is extended from five years to 10 years. The initial registration approval is still only valid for five years.

Concluding remarks

The duplication of the validity time of renewals for drugs and medical device registration is expected to significantly reduce the workload on the COFEPRIS online platform. This is a favorable development in addition to the Regulatory Reference Authority (RRA) Equivalence routes and immediate approval modifications announced in 2025.

COFEPRIS appears committed to simplifying the medical device regulatory landscape.