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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
Manufacturers looking to register devices in India will have to take into account a detailed guidance issued by India’s Central Drugs Standard Control Organization on submission requirements for the registration, reregistration and import of certain diagnostic kits. Read More
Racer Technology, a Singapore maker of cochlear implant accessories, expressed confusion about the term “device history record” during a recent FDA inspection, drawing a warning letter from the agency. Read More
Invacare says it has made “significant progress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final certification to the agency. Read More
The FDA has granted 510(k) clearance for Israel devicemaker EarlySense to market an updated version of its EarlySense bedside monitoring system, the company announced Wednesday. Read More
SinuSys plans to launch its Vent-OS two-step osmotic expansion sinus dilation system immediately in certain markets around the U.S., following receipt of FDA 510(k) clearance. Read More
Medtech companies could wind up in the crosshairs of U.S. government auditors if the payments they report under the Physician Payment Sunshine Act are frequently disputed by doctors and teaching hospitals. Read More