Device Counterfeiting Becoming More Common And More Sophisticated
This article was originally published in The Gray Sheet
Executive Summary
Counterfeiting of medical devices, including sophisticated implantable devices, is a growing threat to patient safety and manufacturers' reputations, Sidley Austin's Brett Rowland warns
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U.K. Regulatory Agency Prioritizes Safety Over International Standards Work
The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) has turned its focus away from international standards work to concentrate instead on investigating medical device safety issues
Limited U.S./China export agreement
Pact inked Dec. 11 between HHS and China's State Food and Drug Administration to enhance the safety of devices and drugs exported to the U.S. from China will cover exports of glucose test strips and condoms. The agreement will require all Chinese producers of the devices to register with the Chinese government and develop and implement a program to certify that the products meet FDA safety standards. The two countries also agreed to notify each other within 24 hours if the devices cause serious adverse health consequences and to exchange lists of registered firms that manufacture the devices. Some in Congress are already critiquing the agreement, saying that the limited list of products it covers falls short of what is needed to protect American consumers from unsafe Chinese imports. The agreement "doesn't cover nearly enough products to restore our confidence in Chinese goods," said Sen. Dick Durbin, D-Ill