Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding ...
Medical device makers are feeling the weight of the Food and Drug Administration’s unique device identifier regulations. Loftware and USDM Life Sciences conducted a nationwide survey that polled ...
On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...
Regulatory oversight has instead been exercised by the NAFDAC pursuant to its general mandate under the NAFDAC Act (Cap N1, ...
The ISO 13485:2016 training course presents a key market opportunity for medical device organizations to enhance their quality management systems, ensuring compliance with industry and regulatory ...
How to Prepare for New Pricing Rules and Consolidation in China's Medical Device Distribution System
Multinational medical device companies have a long history of driving growth through patented products, strong brands, and direct sales force in the United States and Europe. In China, however, ...
Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML evaluation and algorithm change management: CDSCO guidelines ...
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