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Sector radar / Medical devices
Sector brief: what Chinese policy is doing in this sector, how it treats foreign firms, who is named, and what China sells abroad. Every figure links to its documents. Goods: Medical instruments (9018), implants (9021), X-ray and CT (9022).
Next five years: named in 12 of the 15 15th Five-Year Plan outlines held (5.3 mentions per 100k characters), against 6 of 7 14th-plan outlines (4.7): 1.1× as dense; up in 3 and down in 1 of the 4 places with both. Chongqing: “协同打造战略性新兴产业和未来产业高质量发展集聚地，发展创新药、智慧医疗装备产业，打造成渝低空经济带，构建“氢走廊”“电走廊”“智行走廊”等应用场景。” (outline) Plan watch.
Documents held, so collection shapes the curve; the momentum ratio is relative to the corpus.
| Heading | world | growth/yr | EU-27 | EU since 2023 | share of EU imports |
|---|---|---|---|---|---|
| Medical instruments 9018 | $12.7bn | 9% | $2.7bn | 37% | 10% |
| Implants and orthopaedic devices 9021 | $3.0bn | 9% | $715m | 35% | 7% |
| X-ray and CT apparatus 9022 | $3.3bn | 9% | $886m | 0% | 25% |
EU price and volume: imports from China €33.92/kg against €141.78/kg from other suppliers in 2025 (-76%; -74% in 2023). Volume since 2023: China 17%, others -6%.
| Date | Central document | provinces | median lag | |
|---|---|---|---|---|
| 2021-02-09 | 医疗器械监督管理条例 Regulations on the Supervision and Administration of Medical Devices 国务院令第739号 |
22 | 546 d | trace → |
| 2022-03-10 | 医疗器械生产监督管理办法 Measures for the Supervision and Administration of the Manufacture of Medical Devices 国家市场监督管理总局令第53号 |
9 | 1226 d | trace → |
| 2024-12-30 | 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 Opinions of the General Office of the State Council on Comprehensively Deepening Reforms in the Regulation of… 国办发〔2024〕53号 |
8 | 297 d | trace → |
| 2022-03-10 | 医疗器械经营监督管理办法 Measures for the Supervision and Administration of the Distribution of Medical Devices 国家市场监督管理总局令第54号 |
8 | 1119 d | trace → |
| 2021-04-27 | 国务院办公厅关于全面加强药品监管能力建设的实施意见 Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Capac… 国办发〔2021〕16号 |
6 | 184 d | trace → |
| 2021-08-26 | 体外诊断试剂注册与备案管理办法 Measures for the Administration of the Registration and Filing of In Vitro Diagnostic Reagents 国家市场监督管理总局令第48号 |
5 | 1283 d | trace → |
| 2021-08-26 | 医疗器械注册与备案管理办法 Measures for the Administration of the Registration and Filing of Medical Devices |
4 | 1433 d | trace → |
| 2023-12-04 | 国家药监局关于发布医疗器械经营质量管理规范的公告 Announcement by the National Medical Products Administration on the Publication of the Quality Management Spe… |
3 | 485 d | trace → |
Across all State Council directives the median lag to a province's implementing document is about 151 days (middle half 84–259).
| Province | documents (36 m) | leans | with money | favouring | local-only programmes | |
|---|---|---|---|---|---|---|
| Hubei | 19 | ×3.1 | 0 | 1 | 7% of 266 | exposure → |
| Beijing | 16 | ×2.0 | 3 | 1 | 13% of 100 | exposure → |
| Jiangsu | 11 | ×3.5 | 1 | 0 | 6% of 141 | exposure → |
| Shanghai | 11 | ×0.7 | 0 | 1 | 15% of 620 | exposure → |
| Xinjiang | 11 | ×4.9 | 0 | 0 | 3% of 228 | exposure → |
| Fujian | 9 | ×1.8 | 0 | 0 | 2% of 199 | exposure → |
| Zhejiang | 9 | ×1.4 | 0 | 0 | 3% of 417 | exposure → |
| Qinghai | 7 | ×3.7 | 0 | 0 | 0% of 14 | exposure → |
| Inner Mongolia | 5 | ×0.7 | 0 | 0 | 1% of 154 | exposure → |
| Guangdong | 4 | ×0.1 | 1 | 0 | 0% of 67 | exposure → |
| Shandong | 4 | ×1.2 | 1 | 0 | 4% of 169 | exposure → |
| Shaanxi | 4 | ×1.0 | 0 | 0 | 2% of 265 | exposure → |
| 2026-04-07 | 关于2025年国家医疗器械监督抽检不合格产品处置情况的公告（2026年第二期） Announcement on the Disposition of Products Found Non-compliant in the 2025 National Supervision and Random I… |
| 2026-03-20 | 国家药监局关于印发药品现代物流规范化建设指导意见的通知 Notice of the National Medical Products Administration on the Issuance of the Guidelines on the Standardisati… 国药监药管〔2026〕7号 |
| 2026-03-11 | 国家药监局关于“人工智能+药品监管”的实施意见 Implementation Guidelines of the National Medical Products Administration on ‘Artificial Intelligence and Med… 国药监综〔2026〕6号 |
| 2026-03-05 | 河北省药品监督管理局关于发布全省医疗器械监督抽检结果的公告（2026年第一期） Announcement by the Hebei Provincial Drug Administration on the Publication of the Results of Provincial Medi… |
| 2026-02-04 | 河北省药品监督管理局关于调整《河北省药品监督管理系统政务服务事项清单》的公告 Announcement by the Hebei Provincial Drug Administration on the Revision of the ‘List of Administrative Servi… |
| 2025-12-24 | 国家药监局关于发布医疗器械出口销售证明管理规定的公告 Announcement by the National Medical Products Administration on the Issuance of the Administrative Provisions… |
| 2025-12-19 | 国家药监局关于发布互联网药品医疗器械信息服务备案管理规定的公告 Announcement by the National Medical Products Administration on the Issuance of the Provisions on the Filing … |
| 2025-11-04 | 国家药监局关于发布医疗器械生产质量管理规范的公告 Announcement by the National Medical Products Administration on the Publication of the Good Manufacturing Pra… |
| 2026-10-20 | 贵州省健康医药产业高质量发展实施方案（2026-2030年）（征求意见 Implementation Plan for the High-Quality Development of the Health and Pharmaceutical Industry in Guizhou Pro… Guizhou Provincial People's Government |
| 2026-10-09 | 北京市经济和信息化局 北京市卫生健康委员会等部门关于开展2026年高端医疗装备推广应用项目申报工作的通知 Notice from the Beijing Municipal Bureau of Economy and Information Technology, the Beijing Municipal Health … Beijing Municipal Bureau of Economy and Information Technology; Beijing Municipal Bureau of Drug Administration; Beijing Municipal Health Commission |
| 2026-09-18 | 关于广东省人民医院医学影像设备更新升级项目（一）可行性研究报告的批复 reply · Guangdong Provincial Development and Reform Commission |
| 2026-09-18 | 关于广东省人民医院医学影像设备更新升级项目（二）可行性研究报告的批复 reply · Guangdong Provincial Development and Reform Commission |
| 2026-09-01 | 医疗器械行业标准信息表序号标准编号标准名称制修订替代标准适用范围实施日期1YY0267—2025血液净化体外循环系统血液 Document · Xinjiang Autonomous Region People's Government |
| 2026-08-31 | 青海省生态环境厅关于注销青海九域医疗器械有限公司辐射安全许可证的批复 reply · Qinghai Provincial People's Government |
| 2026-08-31 | 青海省生态环境厅关于青海诚裕医疗器械有限公司申领辐射安全许可证的批复 reply · Qinghai Provincial People's Government |
| 2026-08-25 | 省药品监督管理局关于取消医疗器械网络交易服务第三方平台备案凭证的通告 circular · Hubei Provincial Bureau of Drug Administration |
| 2026-08-23 | 西安市人民政府办公厅关于公布行政许可事项清单（2026年版）的通知 notice · General Office of the Xi'an Municipal People's Government |
| 2026-08-04 | 鄂尔多斯市行政审批政务服务与数据管理局 关于注销第三类医疗器械经营许可证的公告 （2026年第1批） Document · 鄂尔多斯市政数局 |
| Measure | Group | Found | checked precision |
|---|---|---|---|
| Capital grant | Fiscal and financial support | 14 | 70% |
| Tax relief | Fiscal and financial support | 6 | 80% |
| Local registration condition | Localisation conditions | 2 | 60% |
| Interest subsidy | Fiscal and financial support | 2 | 90% |
| Foreign investment rule | Trade and foreign investment | 2 | not checked |
| Usage privilege | Usage privileges | 2 | not checked |
| Credit guarantee | Fiscal and financial support | 1 | 90% |
| Import duty relief on inputs | Trade and foreign investment | 1 | not checked |
| Policy lending | Fiscal and financial support | 1 | not checked |
| Local production condition | Localisation conditions | 1 | 20% |
Precision from the Data page: samples of ten, checked by the AI assistant; a human-coded sample is still to come.
| Provision | How | Disadvantages |
|---|---|---|
| “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。”
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 京商函字〔2026〕376号 · 2026-05-11 |
Local registration / tax | other regions |
| “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…”
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 鄂药监发〔2026〕1号 · 2026-02-28 |
Local registration / tax | other regions |
| “对在研重点药品、进口转本地生产药品优先进行注册抽样和检查，同步开展注册核查与生产质量管理规范符合性检查。”
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 |
Local production requirement | imports, other regions |
| “业务）审批意见书定》管理局电信企业落实股比限制强信用监管，向社会公布电信业务”
西规〔2021〕009/市政府001西安市人民政府文件市政发〔2021〕10号西安市人民政府关于印发深化“证照… 市政发〔2021〕10号 · 2021-08-13 |
Ownership, own-brand or own-IP test | foreign-owned firms |
| “7.“产地”分为“本国企业境内生产”（指由中方独资或中方控股企业在境内生产）、“外资企业境内生产”（指外资企业在境内设厂生产）、“国外进口”（指在境外生产并通过海关报关进入我国）。”
省卫生健康委关于印发湖北省乙类大型医用设备配置许可与监督管理实施细则和湖北省社会办医疗机构乙类大型医用设备备案… 鄂卫规〔2021〕3号 · 2021-06-23 |
Ownership, own-brand or own-IP test | foreign-owned firms |
| “支持药械企业享受《泉州市进一步支持民营企业健康发展行动方案》（泉委办发〔2018〕34号）的各项优惠政策，把药械行业纳入支持民营投资项目清单，积极引导社会资本、民间资本进入，盘活“闲置”批文。”
泉州市人民政府办公室关于推进药品医疗器械研发创新促进产业健康发展的通知 泉政办〔2019〕15号 · 2019-02-25 |
SOE or private-firm preference | SOEs |
Keyword and model screens: leads to check against the document, not findings. Newest first, one per document.
| No in-force date in the next 12 months. |
| 2027-05-01 | 医疗器械生产监督管理办法 State Administration for Market Regulat… |
| 2027-06-30 | 关于做好国家组织药物涂层球囊类、泌尿介入类及4批省际联盟医用耗材、体外诊断试剂集中带量采购中选结果执行工作的通知 Xinjiang Autonomous Region Healthcare S… |
| Firm | Ownership | Listings |
|---|---|---|
| 深圳市达科为生物工程有限公司 | unclassified | 55 |
| 巴德生物科技有限公司 | unclassified | 38 |
| 江苏康普生物医药科技有限公司 | unclassified | 18 |
| 深圳市森盈生物科技有限公司 | unclassified | 16 |
| 南京普诺基生物科技有限公司 | unclassified | 9 |
| 深圳联兴医疗科技有限公司 | unclassified | 8 |
| 深圳市科曼医疗设备有限公司 | unclassified | 6 |
| 深圳市生强科技有限公司 | unclassified | 6 |
| 深圳达盟生物科技有限公司 | unclassified | 6 |
| 常州威克医疗器械有限公司 | unclassified | 6 |
| 亚辉龙生物科技（南京）有限公司 | unclassified | 6 |
| 骨圣元化机器人（深圳）有限公司 | unclassified | 5 |
Foreign-owned and joint ventures named:
江苏德尔福医疗器械有限公司 (1)
No listed group in this sector with HKEX grants extracted.
214 documents whose title matches 医疗器械|医疗装备|体外诊断|医学影像, plus 167 in the topic tree medtech; 300 together. Goods: HS 9018, 9021, 9022. Measures and preference provisions are screen output; open each document for the clause.