IPSNEWS
Regulatory Update New Agreement on Health Supply Import Permits Ensures Public Sector Access
On December 4, 2024, an agreement was published in the Official Journal of the Federation (DOF), outlining the requirements for importing medicines and medical devices for the public sector. This agreement allows importing these products without a COFEPRIS sanitary registration, provided certain criteria are met. It aims to expedite supply processes, especially for consolidated purchases under BIRMEX scheme.
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.
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.
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.
Regulatory Update on the Commercial Diagnostic Test Evaluation Process at the Institute of Epidemiological Diagnosis and Reference (INDRE)
The communication issued by INDRE informs about the opening process for requesting the evaluation of commercial diagnostic tests.
Regulatory Update Guide for Modifications to Medical Device Registrations.
The guide provides detailed criteria and requirements for requesting administrative and technical modifications to medical device sanitary registration conditions in Mexico.