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What is the significance of having an Operating License?
This license serves as an official notification to the health authority, outlining the activities, products, and/or services offered by the establishment. This process enables COFEPRIS to effectively exercise its sanitary control and surveillance functions.
Mexico’s Health Leaders Convene at French Healthcare Day
IPS proudly sponsored this event, which brought together health sector experts and government leaders to analyze the complexities of nutrition and diabetes in Mexico.
Understanding the Difference Between Advertising Notices and Permits
In Mexico, advertising of products and services for human use or consumption is regulated by COFEPRIS and requires an authorization that can be a notice or a permit, depending on the type of product or service. Both procedures are carried out in order to guarantee compliance with the corresponding regulatory framework, avoid sanctions, and ensure responsible advertising.
Sanitary surveillance actions for dietary supplements in Mexico
The Federal Commission for Protection against Sanitary Risks (COFEPRIS) is entrusted with the crucial task of overseeing and regulating products and services intended for human consumption, such as food supplements, to ensure their quality and safety. This article explores the surveillance actions undertaken by COFEPRIS and the key aspects companies should consider.
Regulatory Update Agreement on Equivalence of Sanitary Registration and Importation Requirements for Health Supplies
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.
Regulatory Update Mexico Releases Draft Standard for Medical Device Manufacturing: SaMD & QMS in Focus (Updated)
Mexico published a draft standard (PROY-NOM-241-SSA1-2024) on June 26th for public review. This update aims to make Good Manufacturing Practices for Medical Devices more specific by including details on areas like quality management and software as medical device.
Dietary Supplements: Regulatory Framework in Mexico
Mexico's dietary supplement market is growing rapidly, offering opportunities but also intense competition. Understanding and complying with COFEPRIS regulations is crucial to avoid legal issues. This document outlines these requirements for manufacturers and marketers.
Regulatory Update Lists of additives and adjuvants permitted by COFEPRIS
One of the consultation documents for dietary supplements is the list of additives and adjuvants published by COFEPRIS. These lists have been updated.