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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

Notice from the Beijing Municipal Bureau of Commerce on the Issuance of the ‘Work Plan for Promoting the Development of the Pharmaceutical and Healthcare Industry and Facilitating the Import of Pharmaceutical and Medical Device Products’
京商函字〔2026〕376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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · 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 50942 · recorded trade USD 484,186,890

Implementing jurisdiction: China · intervention 50942

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 …
研究制定医疗器械注册证跨省转移的落地政策与服务流程,对转入本市注册的Ⅱ类医疗器械,优化申报资料及核查程序。
Tells lower levels to act; not itself a measure in force.

Asymmetric provisions

Local registration / tax (本地注册, 纳税)
Disadvantages: firms from other regions · Keyword screen (unreviewed)
研究制定医疗器械注册证跨省转移的落地政策与服务流程,对转入本市注册的Ⅱ类医疗器械,优化申报资料及核查程序。

Same central policy, other provinces

ProvinceFirst document citing itDatedLag
Guizhou 贵州省药品监督管理局2025年工作要点 2025-02-05 37 d
Jiangsu 省政府办公厅印发关于全面推进药品医疗器械监管深层次改革促进医药产业高质量发展若干政策措施的通知(苏政办规〔2025〕4号) 2025-08-12 225 d
Xinjiang 国家药监局关于发布中药生产监督管理专门规定的公告(2025年第79号) 2025-08-25 238 d
Ningxia 宁夏回族自治区人民政府办公厅印发《宁夏回族自治区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若干措施》的通知 2025-09-26 270 d
Shanghai 上海市人民政府办公厅关于印发《上海市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若干措施》的通知 2025-10-23 297 d
Chongqing 重庆市人民政府办公厅关于印发《重庆市深化药品医疗器械监管改革促进医药产业高质量发展若干措施》的通知 2026-01-21 387 d
Hubei 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 2026-02-28 425 d
Beijing this document 2026-05-11 497 d
Held documents only: these are counts of what we have collected, not of what each province issued.

Full text

京商函字〔2026〕376号 各相关单位: 为加快推进本市医药健康产业发展,促进药械产品进口,现将《推进医药健康产业发展促进药械产品进口工作方案》印发给你们。请各单位高度重视,按照责任分工,加快推动有关任务落地见效。 特此通知。 北京市商务局 2026年5月11日 推进医药健康产业发展促进药械产品进口工作方案 医药健康产业是战略性新兴产业,是本市万亿级产业,也是推动本市发展的重要引擎。为深入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),加快推进本市医药健康产业发展,促进药械产品进口,推动进出口平衡发展,特制定本工作方案。 一、总体思路 坚持问题导向、目标导向,以“稳存量、拓增量、谋创新、优生态、提效率”为核心,充分发挥“两区”建设制度创新优势,聚焦医药健康产业进口关键环节,通过政府跨部门协同与企业精准服务,将政策优势、监管优势、市场优势切实转化为产业发展动能,提高医药健康产业“北京服务”水平,提升进口便利性和通关效率,扩大药品和医疗器械产品进口,做大“出口中国”品牌。 二、重点任务 (一)畅通进口通路,全力提升通关效率 1.优化临床急需药械进口审批绿色通道。充分发挥临床急需药械临时进口联席工作机制作用,加强对医疗机构的服务指导,持续扩充临床急需临时进口药械品类,更好地服务临床需求。(责任单位:市药监局、市卫生健康委、市医保局、北京海关) 2.探索优化临床研发用药进口流程。建立市级进口通关环节弹性管理机制,探索对暂无临床试验批件、但持合规医院伦理批件的海外未上市临床对照药、临床试验用药(含生物等效性试验、早期阶段试验用药)及研究者发起试验用药,简化通关单证流程,设立“研发用药绿色通道”,加快关键研发物资入境。(责任单位:市药监局、北京海关) 3.加强部门信息共享。按需共享药械集采价格,强化相关政府部门协调配合,提高服务保障水平。(责任单位:市医保局、北京海关) 4.提升货物运输效率。依托北京航空“双枢纽”,加快推进天竺综保区南北区联络线及园区附属设施工程,节省运输成本和运输时间;推进大兴机场综保区区港联络通道全面运行,提高通关效率。[责任单位:首都机场临空经济区管委会、大兴机场临空经济区联合管委会、大兴机场临空经济区(大兴)管委会] (二)做大产业增量,着力提升进口规模 5.吸引更多药械品种与进口代理人落户北京。依托外资医药企业工作专班等机制,积极争取跨国药械企业将更多产品的进口代理人资格或全国总经销业务落地北京。(责任单位:市卫生健康委、市科委中关村管委会) 6.探索医疗器械注册证跨省转移。研究制定医疗器械注册证跨省转移的落地政策与服务流程,对转入本市注册的Ⅱ类医疗器械,优化申报资料及核查程序。(责任单位:市药监局) 7.加强临床急需医疗器械入院指导。支持并指导医疗机构申请国家医保医用耗材编码,鼓励医疗机构使用的药品和医用耗材通过平台采购或登记。(责任单位:市医保局) 8.持续深化罕见病药品保障先行区建设。拓展临床急需和罕见病临时进口药品品种,推动更多临时进口品种在京临床应用。争取扩大罕见病药品贸易企业和医疗机构白名单。[责任单位:市药监局、市卫生健康委、市医保局、首都机场临空经济区管委会、大兴机场临空经济区联合管委会、大兴机场临空经济区(大兴)管委会] (三)强化改革创新,激发产业发展活力 9.开展临床急需进口罕见病类和特定全营养特殊医学用途配方食品需求调研。(责任单位:市市场监管局、市卫生健康委、北京海关) 10.争取将国外已上市、计划在国内上市注册的新产品纳入国家医保信息业务编码标准数据库,新产品不能匹配现行分类目录的,申请创建新的分类目录号。(责任单位:市医保局) 11.推动“诊、研、产、贸”一体化发展。依托北京已有的医药贸易产业基础和口岸、保税政策优势,支持医疗机构与贸易企业、研发机构开展“临床—产业”联动,通过临床试验协作等方式,反哺研发与生产,推动诊疗、研发、生产与贸易环节深度融合。(责任单位:市卫生健康委、市药监局) 12.发展“保税+”新业态。支持生物医药企业在综合保税区内开展保税维修、研发、检测等业务,促进科技创新和产业创新融合发展。(责任单位:各综保区管理机构、北京海关、市商务局) (四)深化政企服务,优化产业发展生态 13.完善创新药械全生命周期服务。围绕药品和医疗器械注册、备案、检验、报关、流通、医保服务等环节,为企业提供预沟通和指导,提升便利化水平和效率。(责任单位:市商务局、市药监局、北京海关、市卫生健康委、市医保局) 14.搭建医药健康国际交流平台。依托中国国际服务贸易交易会、中关村论坛等国家级平台,支持举办医药健康领域国际化论坛。支持企业“走出去”参加国际性展会,帮助企业拓展国际市场。(责任单位:市商务局、市科委中关村管委会、市药监局、市卫生健康委) 15.加大政策宣传力度。支持有关区组织召开医药健康企业政策宣讲会;面向跨国医药健康企业,组织举办小规模、精准化的对接推介会,宣贯惠企政策及北京优势。(责任单位:市商务局、市药监局、市卫生健康委) 三、保障措施 1.强化部门协同。各相关部门主动靠前服务,聚焦药械产品全生命周期发展需求,形成政策与服务合力,构建医药健康产业全链条创新生态体系。 2.加强制度创新。发挥“两区”建设先行先试优势,针对企业反映的共性问题和合理诉求,积极探索优化监管和服务的创新举措。 3.健全沟通机制。建立政企沟通与问题解决机制,定期举办政府部门与相关企业的座谈会,确保企业诉求能够及时得到回应及解决。