IPSNEWS
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
Regulatory Update China is now part of the Hague Convention of Apostille
Starting November 7th, 2023, Mexican Representations in China will no longer issue legalizations. Instead, Chinese public documents must be apostilled by the corresponding Chinese authorities to be valid in Mexico.
Regulatory Update MDSAP
COFEPRIS accepts MDSAP as an alternative to a certificate of good manufacturing practices for medical devices.