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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