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Devicemakers that operate in Brazil should be checking to see that none of their business holdings has been charged with corrupt practices — either in Brazil or elsewhere in the world, experts warned during a recent American Bar Association meeting devoted to the country’s new antibribery law. Read More
In the latest effort to clean up India’s troubled clinical trial industry, the government is requiring that clinical investigators video record the informed consent process with each study subject. Read More
Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More
A series of joint assessments of EU device notified bodies found a “generally satisfactory” level of compliance with legal requirements and best practices, but revealed multiple issues with organizational requirements and quality management systems, according to an interim report by the Notified Bodies of Government. Read More
In vitro diagnostics products meant for research or investigational use used commercially without appropriate approvals may be considered adulterated and misbranded, an FDA final guidance says. Read More
Washington, D.C.-based MedStar Health has signed a deal licensing to InnoVital Systems the intellectual property rights to the artificial muscle technology that it hopes will power the InVent diaphragm assist device. Read More
The IMDRF has released a proposal that will guide devicemakers on producing a comprehensive Table of Contents for premarket IVD applications. Read More
EU devicemakers will have a chance to speak directly with top FDA officials at a three-day workshop on human factors for medical devices scheduled for April 1-3, 2014. Read More
Sitoa Global and the University of California San Francisco have signed a letter of intent to negotiate an option agreement for the license of a stereotactic device to deliver stem cells directly into the brain. Read More
The FDA has granted 510(k) clearance for Bruker's MALDI Biotyper CA system for the identification of Gram negative bacteria from human samples using proteomic fingerprinting. Read More
The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data. Read More