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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
Results from Team-NB’s third member survey shows a 10 percent decline in the number of ISO 13485 certificates issued to devicemakers last year. Read More
Companies filing premarket approval applications for in vitro companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, Japan’s Pharmaceuticals and Medical Devices Agency says in recent technical guidance. Read More
Malaysia’s Medical Device Authority has released a 12-step guideline for submitting registration applications for in vitro diagnostic products through the agency’s web-based system. Read More
Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More