Regulatory Update

Regulatory Update Agreement on Equivalence of Sanitary Registration and Importation Requirements for Health Supplies

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)

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)

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)

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.

Regulatory Update COFEPRIS Proposal Agreement to recognize decisions made by Reference Regulatory Agencies.

Regulatory Update COFEPRIS Proposal Agreement to recognize decisions made by Reference Regulatory Agencies.

The proposal agreement aims to establish provisions for COFEPRIS to utilize and recognize decisions made by Reference Regulatory Authorities and the WHO Prequalification Program for the sanitary registration and life cycle management of health supplies