On January 15, 2026, the COFEPRIS of Mexico has promulgated a decree amending the General Health Law (Ley General de Salud) for all health products.
This reform includes considerations for 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.
The key details are as follows.
1) 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.
2) Expands verification activities from only physical visits to also include documentary or electronic means.
Public comments on the draft amendment will be accepted until May 13.
3) The validity of registration renewals is extended from five years to 10 years. The initial registration approval is still only valid for five years.
The decree amended, added, and repealed several provisions, taking effect on January 16, one day after its publication in the Official Gazette (Diario Oficial de la Federación).
Please refer to the attached documents below.
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