US and UK Partner to Speed Up Approval of Medical Devices
美英攜手合作，加速醫療器材審批進程
In a move that signals a new era of regulatory diplomacy, the UK and US have partnered to accelerate the approval of cutting-edge medical devices.
英國與美國建立合作夥伴關係，標誌著監管外交新時代的到來，旨在加速尖端醫療設備的批准。
By aligning the work of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S.
透過整合英國藥品和健康產品監管局(MHRA)與美國食品藥物管理局(FDA)的工作，兩國致力於減少冗餘障礙並促進全球創新。
Food and Drug Administration (FDA), the two nations aim to reduce redundant hurdles and foster global innovation.
一項關鍵組成部分是開發依賴路徑，允許MHRA利用美國已建立的路徑，如510(k)、De Novo和上市前批准(PMA)流程。
A key component is the development of reliance routes, allowing the MHRA to leverage established US pathways like the 510(k), De Novo, and Premarket Approval (PMA) processes.
此外，MHRA正與美國專家合作，共同制定醫療保健領域人工智慧(AI)的標準。
Furthermore, the MHRA is engaging with US experts to shape standards for AI in healthcare.
這項合作預計將於2026年提出立法框架，並於2027年全面實施，旨在更快地將安全技術提供給病患。
By bridging the gap between domestic needs and global benchmarks, the UK is positioning itself as an innovation-ready hub, proving that smart regulatory policy can directly benefit patient health on both sides of the Atlantic.
