COFEPRIS announces measures to accelerate entry of next generation medical devices in Mexico

Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has announced four new measures to improve access to latest medical devices for patients. The measures include replacing the Inspection Report of good practices by US manufacturers with ISO 13485:2003 certification, non-requirement of sanitary registration to import medical devices, launch of High Productivity Group on medical devices to reduce the backlog in processing. COFEPRIS proposed a move to ease customs practices and prevent departure delays for medical devices with typographical errors. These new measures may result in 28% rise in medical devices’ supply in Mexico by 2015-end.


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