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省药品监督管理局关于印发 《关于支持医疗器械产业高质量发展服务支点建设的若干措施》的通知

Notice from the Provincial Drug Administration on the Issuance of the ‘Several Measures on Supporting the High-Quality Development of the Medical Device Industry and Serving the Construction of Strategic Hubs’
鄂药监发〔2026〕1号
Radar: Medical devices (rank 13 of 16) · Pharmaceuticals (rank 4 of 16)

Country-interest evidence · pilot

Trade inferences use UN Comtrade, with China as reporter. Country connections indicate potential trade relevance, not measured harm, firm-level exposure or legal applicability. Inward measures concern exporters to China; competition with Chinese exports in third markets is not assessed.

Inspect implementing jurisdictions and partner evidence · 48 relationships

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 272,149,773

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 148,030,024

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 31,292,163

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 8,460,666

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 16,118,960

Barbados: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 11,004,211

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 93,440,082

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 814,796,838

Costa Rica: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 679,629,844

Czech Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 107,859,223

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 3,068,403,281

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 148,409,183

Dominican Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 189,707,073

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 20,630,348

Estonia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 1,105,508

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 56,505,049

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 438,228,197

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 240,078,423

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 2,058,476

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 20,502,653

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 17,974,796

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 118,810,902

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 1,030,519,031

Iceland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 4,148,196

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 337,538,216

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 137,268,900

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 1,406,803,703

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 569,417,891

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 2,489,119,888

Malaysia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 321,662,041

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 335,717,521

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 12,416,162

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 31,757,322

Pakistan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 11,227,490

Philippines: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 11,418,343

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 53,193,456

Romania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 13,216,669

Russian Federation: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 3,332,959

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 345,699,744

Slovak Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 2,612,769

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 9,795,314

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 115,016,138

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 109,823,049

Turkey: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 53,467,673

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 126,165,825

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 4,563,459,822

Vietnam: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 56943 · recorded trade USD 484,186,890

Implementing jurisdiction: China · intervention 56943

Assessment states
  • Trade-based partners recorded

Measures

Local registration condition
Provincial · locality: Local firms · CPC 481 · Keyword screen (unreviewed)
Implemented by China (subnational) · affects 47 partners (inferred from trade data, 2025 trade): United States, Germany, Mexico, Japan, Ireland, Switzerland …
Stated rationale
  • Regional development · document title or opening · unreviewed 助力加快建成中部地区崛起重要战略支点
对境内隶属于同一集团或者具有同一实际控制人的企业，将已获准境内注册且在有效期内的第二类医疗器械注册证迁入我省注册且自行生产的，若产品无实质改变，符合现行法律法规及强制性标准，完成工艺验证且检验合格的，在申报产品注册时，可使用原产品注册时的综述资料、非临床资料（安全和性能基本原则清单、产品技术要求及检验报告除外）、临床评价资料，5个工作日内完成技术审评。

Asymmetric provisions

Local registration / tax (本地注册, 纳税)
Disadvantages: firms from other regions · Keyword screen (unreviewed)
对境内隶属于同一集团或者具有同一实际控制人的企业，将已获准境内注册且在有效期内的第二类医疗器械注册证迁入我省注册且自行生产的，若产品无实质改变，符合现行法律法规及强制性标准，完成工艺验证且检验合格的，在申报产品注册时，可使用原产品注册时的综述资料、非临床资料（安全和性能基本原则清单、产品技术要求及检验报告除外）、临床评价资料，5个工作日内完成技术审评。

Same central policy, other provinces

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Beijing 北京市商务局关于印发《推进医药健康产业发展促进药械产品进口工作方案》的通知 2026-05-11 497 d
国家药监局关于发布医疗器械生产质量管理规范的公告 · 2025-11-04 · answered in 2 provinces held · trace it ↗
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Held documents only: these are counts of what we have collected, not of what each province issued.

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各市、州、直管市、神农架林区市场监督管理局，省局各处室、分局、直属单位： 《关于支持医疗器械产业高质量发展服务支点建设的若干措施》已经省局局长办公会审议通过，现印发给你们，请结合实际，抓好贯彻实施。 湖北省药品监督管理局 2026年2月28日 关于支持医疗器械产业高质量发展 服务支点建设的若干措施 为贯彻落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》（国办发〔2024〕53号）和《国家药监局关于发布优化全生命周期监管支持高端医疗器械创新发展有关举措的公告》（2025年第63号）等有关要求，着力打造“雨林式”创新生态，促进我省医疗器械产业高质量发展和高水平安全，助力加快建成中部地区崛起重要战略支点，结合我省实际，制定本措施。 一、优化注册检验。畅通创新医疗器械优先检验绿色通道，对临床急需医疗器械实行即收即检。推行多台同型号样机并行检验，进一步缩短检验周期。常态化开展产品检验技术咨询、专题培训等服务，提高产品检验一次性合格率。建立“研检同行”机制，对纳入创新特别审查程序和前置审评通道的产品，采取提前介入、个性化服务，进一步缩短产品上市进程。 二、优化审评服务。建立注册申报和补正资料预审查机制，开展技术审评、注册核查前置服务，提高注册申报一次性通过率。优化第二类医疗器械产品注册流程，技术审评时限由法定60个工作日缩短为平均40个工作日，申报资料补正后的技术审评时限由法定60个工作日缩短为平均30个工作日。对纳入第二类创新特别审查程序的产品，优先开展技术审评和注册体系核查，在30个工作日内完成技术审评。建立重点产品“研审联动”机制，及时指导企业解决临床试验和注册申报中遇到的难题。建立多渠道多层次沟通机制，办好医疗器械注册“小课堂”“大讲堂”，充分发挥国家药监局药品和医疗器械审评检查华中分中心和医疗器械创新服务央地联动机制作用，加强对注册申报政策的宣传解读。 三、优化审批流程。对认定为创新和优先审批的第二类医疗器械行政审批时限压缩50%。对境内隶属于同一集团或者具有同一实际控制人的企业，将已获准境内注册且在有效期内的第二类医疗器械注册证迁入我省注册且自行生产的，若产品无实质改变，符合现行法律法规及强制性标准，完成工艺验证且检验合格的，在申报产品注册时，可使用原产品注册时的综述资料、非临床资料（安全和性能基本原则清单、产品技术要求及检验报告除外）、临床评价资料，5个工作日内完成技术审评。优化已在境内上市的境外生产医疗器械转移至境内生产的审评审批流程，支持外商投资企业将高端医疗装备等引进境内生产。 四、优化检查执法。强化面向企业的质量安全警示教育和法规培训，督促企业全面完善质量管理体系。根据产品风险和企业监管等级，科学制定年度监督检查计划，合理确定检查频次，减少重复检查。合并开展第二类、第三类医疗器械注册核查与生产许可检查。对同时生产第一类医疗器械的第二类、第三类医疗器械生产企业，开展合并检查。根据检查需要，统筹注册核查、监督检查、许可检查内容，避免同一项目重复检查。对新产业、新业态、新模式的经营主体，采取包容审慎监管，推行说理式执法。围绕建设全国统一大市场，打破市场壁垒，破除“内卷式”竞争，着力打造市场化、法治化、国际化一流营商环境。 五、支持企业研发创新。支持医用机器人、高端医学影像设备、人工智能、脑机接口和新型生物材料等高端医疗器械发展，对符合要求的国内首创、国际领先，且具有显著临床应用价值的高端医疗器械，优先推荐进入国家前置审评通道或创新审查特别程序。建立“服务专员”制度，按照“提前介入、一企一策、全程指导、研审联动”要求，将审评审批资源更多向临床急需的重点创新医疗器械倾斜，在检验核查、临床试验、注册申报、审评审批等全过程加强沟通交流，提供个性化指导。 六、支持临床成果转化。扎实开展医疗器械临床创新成果转化“春雨行动”，推进以临床价值为导向的医疗器械源头创新，促进更多临床创新成果向医疗器械产品转化。搭建省级临床研究成果转化平台，推进临床研究成果信息共享和供需对接。联合省科技厅、经信厅、卫健委开展医工交叉创新发展大赛、生命健康科技创新创业大赛等活动，推动各种资源要素有效衔接。积极争取将更多医疗机构纳入自行研制使用体外诊断试剂（LDT）试点范围。鼓励高水平医疗机构自行研制使用国内尚无同品种产品上市的罕见病用诊断试剂。 七、支持开展临床试验。对具备条件的医疗机构依法备案为医疗器械临床试验机构，支持已备案临床试验机构按规定扩大临床试验专业范围。对符合条件的罕见病用创新医疗器械减免临床试验，鼓励企业开展国际多中心临床试验，促进全球创新医疗器械在湖北省同步研发、同步申报、同步审评、同步上市。 八、支持产品推广使用。支持创新医疗器械列入湖北省创新产品应用示范推荐目录、纳入医保支付范围，鼓励医疗机构采购使用。支持医疗器械企业拓展海外市场，将出具出口销售证明的范围拓展到所有具备资质的企业按照生产质量管理规范生产的医疗器械，助推医疗器械产品出海。 九、促进企业规范发展。监督指导企业实施新版《医疗器械生产质量管理规范》，完善质量管理体系，提高质量管理水平，落实质量安全主体责任。指导医疗器械注册人利用医疗器械警戒新工具、新方法开展不良事件监测数据的信号挖掘与利用。推动医疗器械注册人开展上市后循证研究。充分发挥医疗器械行业协会作用，积极引导行业自律与诚信建设。 十、促进产业提档升级。加强行业动态分析和政策指引，引导企业优化产品结构布局，防止低水平重复。以监督实施新版《医疗器械生产质量管理规范》为契机，推进信息技术与产业链深度融合。支持医疗器械生产企业广泛应用物联网感知设备、制造执行系统（MES）等，提升生产流程的透明化与可控性。支持医疗器械生产企业数智化转型，建设智能化工厂，推动关键工序数字化改造，实现生产过程的实时监控与数据自动采集。 十一、促进产业链深度融合。联合有关部门、单位建立医疗器械全产业链融合贯通体系，推进创新链、产业链、资金链、人才链深度融合、协同发展。联合有关部门、单位打造“政产学研医金服用”平台，推动各种资源要素高效对接、有效利用。支持第三方合同研究组织（CRO）、合同制造组织（CMO）、合同研发与制造组织（CDMO）参与医疗器械研发、注册申报和成果转化等工作，对重点项目实行专人跟踪指导服务。支持省内第三方检验检测机构依法取得医疗器械检验检测资质，持续提升检验检测能力，推动检验检测结果在审评检查中认可。鼓励专利服务机构介入研发过程，辅导企业开展高价值专利布局与知识产权风险预警。 十二、促进产业集群发展。支持医疗器械企业、医疗机构、高等院校、科研院所、行业协会等组建产业联盟，实现资源共享、优势互补、协同发展。支持省外企业围绕资源要素和产业链协同，在湖北拓展发展空间，创办经济实体。支持龙头企业联合上下游企业、高校及科研院所成立创新联合体，围绕产业链关键零部件、核心原材料等“卡脖子”技术开展联合攻关。支持产业园区建设共享实验室、中试平台等共性设施，降低小微企业前期孵化研发成本。支持有条件的产业园区设立医疗器械创新服务站，省药监局在技术咨询和人才培养等方面提供服务。深入开展“1+9”生物医药产业园直通车服务，对企业发展诉求实行“清单化管理、项目化推进、闭环化落实、可量化评估”，促进园区做大做强。 附件: