In 2020, Mexico implemented an agreement allowing expedited importation and equivalence of certain health supplies approved by recognized international regulatory bodies, aiming to address shortages and streamline access. However, an update in September 2024 nullified this agreement, requiring full compliance with Mexican regulatory processes for all health supplies.
Regulatory Update COFEPRIS Issues Guidance on Advertising by Influencers (GRUPPI)
On September 4, 2024, COFEPRIS' Advisory Council on Advertising launched the Guide on Roles and Responsibilities of Influencer Advertising (GRRUPI). This tool aims to complement the Regulations of the General Health Law on Advertising (RLGSMP) to regulate the advertising of products and services in a digital context.
Regulatory Update COFEPRIS proposes changes to NOM-240: Responsibilities for Manufacturers and Distributors (Updated)
The Ministry of Health in Mexico is proposing changes to a standard (NOM-240-SSA1-2012) regarding medical device safety and reporting. The draft standard strengthens reporting requirements for manufacturers, distributors and adds new responsibilities. Public feedback is welcome to evaluate the impact of the proposed changes.