医疗器械上市的要求。
Requirements to bring a medical device to market.
作者信息
Buenz Eric J, Wallace Victoria M, Levy Friedman Suzanne
机构信息
Mayo Clinic, Rochester, MN, USA; Device Navigator, Motueka, New Zealand; Nelson Marlborough Institute of Technology, Nelson, New Zealand.
Hogan Lovells US LLP, Washington, DC, USA.
出版信息
Trends Biotechnol. 2025 Jan;43(1):4-7. doi: 10.1016/j.tibtech.2024.07.016. Epub 2024 Aug 23.
A roadmap for medical device innovators is presented that highlights the essential steps for regulatory authorization, market access, and reimbursement strategies in the USA, with a focus on strategic planning for commercial success, underscoring the integration of regulatory and market access considerations from the initial development of a medical device.
本文为医疗器械创新者提供了一份路线图，重点介绍了在美国获得监管批准、进入市场及报销策略的关键步骤，着重强调了实现商业成功的战略规划，突出了从医疗器械最初研发阶段就将监管和市场准入因素相结合的重要性。
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