By Stewart Eisenhart, Emergo Group
Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device registration requirements altogether in an effort to increase market competition, improve public health and boost job creation.
According to officials at COFEPRIS (document in Spanish), the regulator’s moves are based on methods endorsed by the Federal Regulatory Improvement Commission (COFEMER) and recommendations from the Organization for Economic Cooperation and Development (OCDE).
Along with IVDs, COFEPRIS plans eased registration for hygienic products, healing products and dental supplies. As for the 1,700 products that will no longer require registration as medical devices, COFEPRIS will publish a list of these goods in August on its website, www.cofepris.gob.mx.
Simplified registration requirements for IVDs should boost the Mexican market’s appeal for IVD manufacturers looking to expand into new markets. Emergo Group will continue to monitor the situation for further details.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.