Despite some increase in activity, notified body designations under the EU Medical Device Regulation have come in at a glacial pace. A perspective from our sister publication MedTech Strategist Market Pathways: Global Reimbursement, Regulatory & Policy Review.Subscribe now to read the full analysis
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China’s regulatory agency is doing more inspections at device facilities around the world, and National Medical Products Administration audits are logistically more complex than an FDA inspection. Here are survival tips from Vy Tran, who leads regulatory operations at Varian Medical Systems, which recently hosted NMPA auditors at its Palo Alto facility.Subscribe now to read the full analysis