IPSNEWS
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.
Cosmetics: Know the regulation in Mexico
The cosmetics industry in Mexico is subject to a robust regulatory framework enforced by the Federal Commission for Protection against Health Risks (COFEPRIS). This oversight aims to safeguard consumer health and ensure product safety and quality. Given the growing popularity of cosmetics, understanding these regulations is crucial for businesses operating within this sector.
Regulatory Update COFEPRIS Resolves Transfer of Rights within 24 hours
At COFEPRIS's priority lane (VRI) , the transfer of rights for medical devices, pharmaceuticals, pesticides, and plant nutrients will be resolved within 24 business hours, streamlining the process for those involved.
Regulatory Update Proposal to modify the Official Mexican Standard (NOM-137) for medical device labeling (Updated)
The Ministry of Health, through COFEPRIS, released a proposal on March 3rd that aims to modify the Official Mexican Standard NOM-137-SSA1-2008 for medical device labeling.
NAVIGATE THE ADVERTISING LANDSCAPE IN MEXICO WITH CONFIDENCE
COFEPRIS develops and enforces advertising guidelines that ensure product claims are accurate, truthful, and not misleading. This helps to protect consumers from false or exaggerated claims that could influence their purchasing decisions.