IPSNEWS
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.
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
Regulatory Update COFEPRIS ensures resolutions within 24 hours for some modifications to medical device registrations (updated)
COFEPRIS reduces turnaround times and ensures resolutions within a 24-hour timeframe for some modifications to medical device's sanitary registrations.
Regulatory Update Guide for Obtaining a Medical Device Registration
Unlocking Medical Device Sales in Mexico: Your Simplified Guide to COFEPRIS Sanitary Registration