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U. S. industry group AdvaMed has hung up its shingle in Shanghai, aiming to play a more proactive role in regulatory and reimbursement policies impacting devicemakers in China. Read More
The Asian Harmonization Working Party has issued a white paper describing a system of qualifications and classifications for the use of software as a medical device. Read More
Evaluations of diagnostic test accuracy studies should include separate meta-analysis of positive and negative likelihood ratios, according to a draft guideline by the EU Network for Health Technology Assessment. Read More
The U.S. Food and Drug Administration’s guidance development process is in need of a major revamp to speed efforts along and integrate feedback from stakeholders earlier, devicemakers and officials in the Center for Devices and Radiological Health said during a June 5 public workshop. Read More
Australia’s Therapeutic Goods Administration logged a total of 3,309 adverse event reports in 2013, the overwhelming majority from manufacturers, according to a new report. Read More
Australia’s medtech industry association released a white paper last month calling for the Therapeutic Goods Administration to shift its focus from conducting conformity assessment reviews to designating authority of third-party conformity assessment bodies. Read More