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FDAnews Device Daily Bulletin
Nov. 12, 2012 | Vol. 9 No. 222
Devicemakers Can Speed Up Mexican Registration With Equivalency Routes
Medical devicemakers can now register products in Mexico in about six months using foreign equivalency pathways or third-party reviewers, an expert says. Over the past two years, Mexico’s Cofepris has established equivalency with the U.S. Food and Drug Administration, Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to expedite the registration process, which can take nearly two years to complete under the regulator’s standard process, said Ann Marie Boullie, director of business development at Emergo Group.
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