IPSNEWS
Launch of the Medical Device Sanitary Registration Viewer: A step towards information analysis and consultation.
On August 20, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) made the Medical Device Sanitary Registration Viewer available to the public and the industry. This digital public inquiry tool enables the search, verification, and analysis of both current and historical sanitary authorizations issued in the country.
New COFEPRIS Guide: Optimization and agility in the Sanitary Registration of Medical Devices
Seeking to unify current Equivalence Agreements and the Abbreviated Regulatory Pathway, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) has published the Requirements Guide for the Sanitary Registration of Medical Devices.
RAUpdate Reform to the Regulations for Health Supplies (RIS): Validity extension for Medical Devices
The Federal Commission for Protection against Sanitary Risks (COFEPRIS), through the Official Gazette of the Federation (DOF), updated some articles of its Regulations for Health Supplies (RIS, its acronym in Spanish), which helps to improve and reduce processing times.
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