摘要：英国与美国（FDA）的医疗AI监管合作已达成共识，基于未来法规调整（预计2026年进入立法、2027年正式实施新依赖路线），FDA认证将成为企业通往英美两大市场的“全球通行证”，大幅缩短产品准入时间与合规成本。随着2027年新路线落地，FDA标准也将进一步引领全球监管趋势，提前遵循该标准的企业可更好地为未来的国际市场部署与长期竞争力做好准备。
Enhanced collaboration with the US on med tech regulation, with accelerated innovation, strengthened patient safety, and reduced transatlantic barriers to market access.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will today outline moves to deepen collaboration with the US on medical technology regulation, with initiatives to accelerate innovation, strengthen patient safety, and reduce transatlantic barriers to market access.
Speaking at the Advanced Medical Technology Association (AdvaMed) conference in San Diego, MHRA Chief Executive Lawrence Tallon will highlight the agency’s commitment to advancing global regulatory harmonization and its strong partnership with the US Food and Drug Administration (FDA) during his fireside chat with Dr Michelle Tarver (Director, FDA CDRH).
Tallon says, “We continue to work in close collaboration, and are taking steps forward in the relationship between FDA and MHRA to strengthen regulatory alignment and reciprocity. We share an ambition to accelerate joint initiatives, enhance policy development, and identify and work together on strategic opportunities more effectively.”
Tallon also emphasizes that Great Britain’s medtech regulatory reforms will support earlier and safer patient access to innovative technologies, drawing parallels with the FDA’s Total Product Life Cycle Advisory Program (TAP) with opportunities for deeper transatlantic collaboration.
“The US and UK share a common goal – ensuring patients benefit quickly and safely from the latest medical innovations. With US-based thought leadership inputting to our new National AI Commission, and new reliance frameworks for FDA approvals, we are laying the foundations for a truly global, innovation-ready regulatory environment,” adds Tallon.
The MHRA’s new National Commission on the Regulation of AI in Healthcare brings together leading voices from across the UK and internationally,* including US experts Brian Anderson (Coalition for Health AI/CHAI) and Barry Stein (Founder of the Center for AI Innovation in Healthcare), alongside representation from global tech organizations, including Google and Microsoft.
The Commission will shape recommendations on regulating AI-driven medical technologies, contributing to international alignment and accelerating safe access to AI in healthcare and across the UK’s NHS. The NHS is a single, nationwide health system covering over 65 million people, offering unparalleled scale, trusted real-world data, and integrated pathways that make the UK a uniquely competitive environment for health innovation and medtech adoption.
The MHRA confirms that planned international reliance routes will allow medical devices approved by trusted regulators, including the FDA, to gain faster access to the UK market. This includes products cleared through the 510(k), De Novo, and Premarket Approval (PMA) pathways, with a proportionate approach balancing rapid access with robust patient safeguards.
The medtech regulatory reforms in Great Britain are intended to enter legislation in 2026 and open new reliance routes from 2027, further strengthening the global medtech ecosystem.
2025 年 10 月，英国 MHRA 与美国 FDA 达成医疗 AI 监管历史性合作，不仅打破跨大西洋市场壁垒，更让 FDA 认证的战略价值迎来全方位提升，为布局全球的医疗科技企业带来多重利好。需特别说明的是，英国此次医疗技术监管改革及与 FDA 合作相关的新依赖路线目前尚未正式落地，其具体实行时间已形成明确规划 —— 英国医疗技术监管改革计划于 2026 年进入立法，并从 2027 年起开辟新的依赖路线，进一步加强全球医疗技术生态系统。
一、FDA 认证成 “全球通行证”，市场准入效率未来将显著飙升
合作核心的 “国际信赖途径” 设计目标为，让 FDA 获批医疗器械未来可通过简化流程直接进入英国市场，无需重复应对英国原有的复杂审批。按照上述时间规划，待 2026 年改革进入立法、2027 年新依赖路线正式实施后，一份 FDA 认证有望相当于同时拿到美国、英国两大高价值市场的 “入场券”，大幅缩短产品在欧美核心市场的落地周期。
从预期效果来看，这一机制未来能将产品进入英国的时间缩短 30%-50%。待 2027 年新依赖路线正式落地后，企业无需为英美市场分别准备两套认证材料，仅需围绕 FDA 标准完成一次核心合规，即可快速覆盖跨大西洋市场，显著降低多市场布局的时间与资金成本。
二、FDA 监管标准话语权增强，未来将引领全球行业规则
作为合作主导方之一，FDA 的 AI 医疗器械审评标准（如算法透明度、数据质量控制）将在英国医疗技术监管改革（2026 年立法、2027 年实施新依赖路线）落地后，通过专家互派、委员会协作等机制，深度影响英国乃至全球监管体系。随着 2026 年改革进入立法阶段、2027 年新依赖路线启用，未来符合 FDA 要求的技术方案、临床证据，更易获得其他国家监管机构的认可，形成 “以 FDA 为核心” 的国际监管协同趋势。
对企业而言，当下遵循 FDA 标准研发产品，不仅能满足美国本土需求，更能提前适配未来（2027 年新依赖路线实施后）全球主流监管要求，避免日后因标准差异反复调整产品，长期来看大幅降低合规风险，为 2027 年后的市场拓展做好前置准备。
三、FDA 认证企业未来将获资源倾斜，创新与竞争优势待进一步凸显
一方面，待英国医疗技术监管改革（2026 年立法、2027 年实施新依赖路线）落地、新依赖路线正式启动后，FDA 与 MHRA 共享监管沙盒（如英国 “AI Airlock”）等创新工具的机制将逐步兑现，FDA 认证企业可优先进入沙盒开展真实临床测试，在监管监督下快速验证产品安全性与有效性，加速技术迭代进程。
另一方面，对中小型创新企业而言，随着 2027 年新依赖路线的开辟，FDA 认证的 “含金量” 将进一步提升。届时凭借 FDA 认证，企业可低成本切入英国市场，在获取欧洲市场反馈的同时，依托英美市场收益反哺研发环节，形成 “认证 – 市场 – 研发” 的良性循环，在全球竞争中占据先发优势。
此次英美合作，本质上是 FDA 认证国际影响力的一次升级。尽管英国相关医疗技术监管改革及新依赖路线需到 2026 年进入立法、2027 年正式实施，但对企业而言，当下抓住机遇深耕 FDA 认证，不仅能为 2027 年后高效打通英美市场奠定坚实基础，更能以 FDA 标准为支点，构建全球市场的长期竞争力。