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Members of the Council of Europe are at odds over whether to allow reprocessing of single-use devices, and the disagreement could upend efforts to pass device reform legislation before EU elections in May. Read More
A recent appeals court hearing on the Securities and Exchange Commission’s conflict minerals disclosure rule provided no immediate relief for manufacturers — though the line of questioning suggested some judges were sympathetic to industry’s free speech argument against the rule. Read More
China’s National Health and Family Planning Commission plans to “blacklist” devicemakers convicted of bribing government officials and ban sales of their products for two years — four for repeat offenses. Read More
The Central Drugs Standard Control Organization has issued detailed guidance on the registration, reregistration and import of notified in vitro diagnostic kits and on the import of non-notified kits, with the aim of speeding submission reviews and easing the move to electronic submissions. Read More
AdvaMed and Taiwan’s medical device association have signed a memorandum of understanding aimed at supporting medtech innovation and advancing patient care. Read More
Devicemakers must include information on potential pediatric use in most new device submissions under an FDA final rule that takes effect April 10. Read More
SinuSys plans to launch its Vent-OS two-step osmotic expansion sinus dilation system immediately in certain U.S. markets, following receipt of FDA 510(k) clearance. Read More