- Imported medical devices still require NMPA registration by risk class (I/II/III), and Class II/III overseas manufacturers must register their production sites with the NMPA before any China market entry.
进口医疗器械仍须按风险分类（一/二/三类）取得国家药监局注册；二类、三类境外生产企业须向 NMPA 登记生产场地后方可进入中国。- Volume-Based Procurement has expanded from high-value implants into routine consumables: the coronary-stent renewal tender opened in Tianjin on 20 May 2026 with every bidder winning, and a 29-province electrosurgical-knife alliance VBP went live on 1 July 2026.
集中带量采购已从高值植入物扩展到常规耗材：冠脉支架第二轮接续采购 2026 年 5 月 20 日在天津开标、投标企业全部中选；覆盖 29 省的电刀省际联盟集采于 2026 年 7 月 1 日落地。- Domestic substitution is measurably eroding foreign share — foreign penetration in some consumable segments fell from about 45% (2020) to under 25% (2025), and peripheral-vessel balloon localisation rose from 28% (2019) to roughly 58% (2025).
国产替代正在实质侵蚀外资份额——部分耗材外资占比从约 45%（2020）降至 2025 年不足 25%，外周血管球囊国产化率从 28%（2019）升至 2025 年约 58%。- Foreign device makers are answering with in-China production: ERBE’s first locally built high-frequency surgical unit (VIO S CN) received its NMPA certificate on 11 June 2026 and rolled off the line on 1 July 2026.
外资器械企业以”在华生产”应对：爱尔博首台国产高频手术设备 VIO S CN 于 2026 年 6 月 11 日获 NMPA 注册证，7 月 1 日下线。- VBP rules are shifting from “lowest-price-wins” toward value-based evaluation, rewarding firms with genuine technology, scale and supply stability rather than pure cost.
集采规则正从”唯低价”转向综合价值评价，利好具备真实技术、规模与供应稳定性的企业。- The practical foreign-device strategy is to register imports to hold premium segments, localise production to defend volume segments under VBP, and engage the province alliances early.
务实的外资器械策略是：以进口注册守住高端细分，以本地化生产捍卫集采下的走量细分，并尽早介入省际联盟。
Medical-device import registration and the foreign-device strategy under domestic substitution (2026) | 2026 医疗器械进口注册与国产替代下外资器械企业策略
Overview
Medical devices sit at the intersection of tight registration control and aggressive procurement reform. For a foreign device company, market access is a two-stage problem: first clear the NMPA registration gateway (still mandatory and class-based), then survive the commercial gateway of Volume-Based Procurement, where domestic substitution has become the explicit policy direction. 2026 is a pivotal year because VBP has pushed from headline implants — stents, joints — into everyday consumables, and because the 2024 negative-list “clearing” of manufacturing restrictions makes in-China production by a wholly foreign-owned plant straightforward for the first time.
This article explains the import-registration gateway, the 2026 VBP and substitution landscape, why localisation has become the default foreign response, and the practical moves a foreign device group should plan. It is informational guidance, not regulatory or legal advice.
The import-registration gateway
Registration is risk-tiered. Devices are classified Class I (low), Class II (medium) and Class III (high). Class I devices are filed with the provincial NMPA office; Class II and III require registration with the NMPA (via the Centre for Medical Device Evaluation, CMDE). A registration dossier needs product technical requirements, type testing at an accredited laboratory, and a clinical evaluation or trial unless the device falls under an exemption catalogue. Quality-system compliance (Good Manufacturing Practice for medical devices) is inspected, and — critically for importers — overseas manufacturers of Class II/III devices must register their production site with the NMPA.
A frequent blind spot is the clinical-evaluation route. Not every Class II/III device needs a trial: where a product is comparable to an already-marketed same-species device, a literature-and-data “same-species” comparison can support trial exemption; novel or high-risk devices with no predicate still require a trial. The route choice dictates evidence cost and launch pace and should be settled at project kick-off. Imported products also need Chinese labels and package inserts; customs clearance hinges on the NMPA registration certificate as a key document.
The 2026 VBP and substitution landscape
VBP — the “集中带量采购” program that exchanges steep price cuts for committed volume — has become the dominant commercial gate for devices, and 2026 shows it reaching deeper into consumables.
Coronary stents, renewal round. On 20 May 2026 the national organisation opened the second renewal tender for coronary stents in Tianjin. Fifteen enterprises with 30 products bid, all bidders won, and 27 products were pre-selected — including upgraded new products from both foreign players (Medtronic’s “Resolute Onyx”, Abbott, Boston Scientific) and domestic leaders (MicroPort, Lepu, JW). Demand came from 4,468 medical institutions (up 86% vs the first tender) with an annual requirement of about 2.73 million stents (up 155%). Stainless-steel stents were included in the national tender for the first time at a ceiling of ¥848, while the alloy-stent ceiling was raised about 11.9% to ¥949 — a signal that rules are moderating toward value rather than pure price.
Electrosurgical knives, 29-province alliance. A Hunan-led inter-provincial alliance covering 29 provinces, municipalities and the Xinjiang Production and Construction Corps went live on 1 July 2026, with a two-year purchasing cycle and total volume above 20 million units/pieces and a market scale above ¥3.5 billion. In 17 core bidding groups, domestic brands took the lowest bid in 16 — and analysts estimate foreign share of the electrosurgical consumable market (above 50% before the tender) could fall below 30% afterward.
Broader alliance activity. The “3+N” and provincial alliances kept broadening through 2026: dural patches and indwelling needles (Tianjin-led, results published 11 March 2026), digestive-intervention snares, peripheral-vessel balloons and orthopaedic irrigation systems (Hebei-led product briefings in March 2026), plus起搏器 and peripheral micro-catheters spanning 27–29 provinces. The clear trend: VBP is becoming the normal commercial environment across the device catalogue.
Measurable substitution. The effect on foreign share is concrete. In digestive-intervention snares, foreign brands’ share fell from about 45% (2020) to under 25% (2025) as domestic players like Micro-Tech pushed hospital penetration above 70%. In peripheral-vessel constrained balloons — long monopolised by Medtronic and Abbott — localisation rose from 28% (2019) to about 58% (2025) and is expected to exceed 70% after the latest tender, with domestic leaders Lepu, Volcano (Huatai) and HeartCare (MicroPort) capturing share. Foreign brands retain an edge only in complex, high-end niches where price gaps of 3–5× still apply but where VBP’s volume logic steadily erodes the addressable market.
Why localisation is now the default response
Faced with VBP price compression and substitution pressure, an increasing number of foreign device makers are shifting from “import the finished unit” to “build it in China.” The logic is operational as much as commercial.
ERBE’s VIO S CN is the 2026 template. ERBE, the German electrosurgery leader (market share ~43.9% of high-frequency surgical-equipment tenders in Jan–May 2026), had imported its units from Germany, absorbing long shipping and customs lead times and high distribution cost. Its first China-built host, VIO S CN — developed with deep Chinese-team input on the German production system — received its NMPA registration certificate on 11 June 2026 and rolled off the line on 1 July 2026. Local production compresses logistics and import cost and sharply improves supply responsiveness, exactly the variables VBP punishes importers on.
Manufacturing is now open. The 2024 negative list cleared all manufacturing-sector foreign-access restrictions (effective 1 November 2024), so a wholly foreign-owned device manufacturing plant in China no longer faces the sector caps that once applied. Combined with theNMPA production-site registration for Class II/III, a foreign maker can stand up a China plant, register the site, and obtain domestic NMPA certificates for locally made SKUs — converting an “import” into a “domestic product” for tender purposes.
The rules now reward local players’ strengths. VBP design is moving from pure price toward comprehensive value evaluation — technical briefing, clinical argument, cost verification — which preserves reasonable margin for firms with real technology and scale. Local production is the most direct way for a foreign maker to match domestic competitors on price, lead time and supply stability while keeping original-equipment quality.
2026 policy context
- Innovation prioritisation. The Medical Device Supervision and Administration Regulation directs that innovative devices receive priority review and approval, supporting domestic and foreign innovators alike in bringing novel products to market.
- Manufacturing fully open. The 2024 negative list’s removal of the last manufacturing restrictions means device manufacturing welcomes wholly foreign-owned investment nationwide.
- Opening under the 2026 action plan. The “Stabilising and Improving Foreign Investment” action plan (effective 1 July 2026) reinforces a pro-foreign-investment stance across healthcare and supports measures such as drug segmented manufacturing and expanded biotech/hospital pilots — the broader policy backdrop foreign device groups operate within.
What foreign device groups should do next
- Map the portfolio against VBP exposure. Classify each SKU by whether it sits in a tendered category, its substitution risk, and whether it is premium/non-substitutable or volume/price-sensitive.
- Keep importing where defensible. For high-end, clinically differentiated devices with weak domestic predicates, hold the import-registration route and protect premium positioning.
- Localise where volume is at stake. For tendered, price-sensitive lines, stand up or contract China manufacturing, register the site with the NMPA, and obtain domestic certificates to compete on VBP terms.
- Settle the clinical-evaluation route early. Decide same-species comparison, exemption or full trial at kick-off to fix evidence cost and timeline.
- Engage the alliances proactively. Track province-alliance pipelines (Hebei, Tianjin “3+N”, Hunan, Guangdong, Zhejiang) and prepare technical briefings that support value-based evaluation.
- Prepare Chinese labelling, inserts and a traceability system before launch, and treat the NMPA registration certificate as the customs-critical document.
Common pitfalls
- Assuming registration equals access. Clearing NMPA registration is necessary but not sufficient; VBP outcome, not the certificate, often decides volume.
- Importing into a tendered category. Finished-unit imports cannot match localised competitors on VBP price and lead time and will lose share.
- Ignoring the production-site registration. Class II/III overseas manufacturers must register their site with the NMPA — a step easily missed when planning local production.
- Treating VBP as pure price. Rules now weight technology and supply stability; a weak value story loses even when price is competitive.
- Late alliance engagement. By the time a tender opens, grouping and evaluation are largely set; influencing them requires early technical briefing.
Sources
- National Medical Products Administration (NMPA) — official portal: https://www.nmpa.gov.cn
- 国家医疗保障局（NHSA）——集中带量采购：https://www.nhsa.gov.cn/
- 国务院新闻办发布会介绍利用外资固稳促优政策措施 (2026-06): https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm
- 国务院《利用外资固稳促优行动方案》(2026-06): https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm
Related reading
- see also: Healthcare & pharma market access (NMPA) / 医疗医药准入（药监局）
- see also: Pharma opening measures under the 2026 action plan / 医药产业开放新措施
2026 医疗器械进口注册与国产替代下外资器械企业策略
概述
医疗器械处在严格注册控制与激进采购改革的十字路口。对外资器械企业而言，市场准入是两段式问题：先越过国家药监局的注册关口（仍属强制且按类管理），再穿越集中带量采购这一商业关口——而国产替代已是明确的政策方向。2026 年是关键之年：集采从支架、关节等标志性植入物，推进到日常耗材；同时 2024 年版负面清单”清零”制造业准入限制，使外商独资器械工厂在华设厂首次变得顺理成章。
本文说明进口注册关口、2026 年集采与替代格局、为何本土化已成为外资的默认应对，以及外资器械集团应规划的务实举措。本文仅为信息参考，不构成监管或法律意见。
进口注册关口
注册按风险分类管理。器械分为第一类（低）、第二类（中）、第三类（高）。第一类向省级药监部门备案；第二类、第三类须向国家药监局（经医疗器械技术审评中心 CMDE）注册。注册资料需产品技术要求、资质实验室型检，以及临床评价或临床试验（除非属豁免目录）。质量体系（《医疗器械生产质量管理规范》）须受检，且——对进口商关键的是——二类、三类境外生产企业须向国家药监局登记其生产场地。
常见盲点是临床评价路径。并非所有二类、三类器械都需临床试验：若产品与已上市同品种器械可比，可通过文献与数据的”同品种”比对支持免于临床；无同品种可比或高风险的创新器械仍须开展临床试验。该路径选择决定证据成本与上市节奏，应在立项时即敲定。进口产品还须配中文标签与说明书；清关以国家药监局注册证为关键单证。
2026 年集采与替代格局
集中带量采购（”集采”以大幅降价换取约定采购量）已成为器械主导性商业关口，而 2026 年显示其正深入日常耗材。
冠脉支架，接续轮。 2026 年 5 月 20 日，国家组织在天津开标冠脉支架第二轮接续采购。15 家企业、30 个产品投标，投标企业全部中选，27 个产品获拟中选资格——既含外资新品（美敦力”Resolute Onyx”、雅培、波士顿科学），也含国内龙头（微创、乐普、吉威）。填报需求来自 4468 家医疗机构（较首轮增 86%），年度需求量约 273 万个（增 155%）。不锈钢支架首次纳入国家集采，最高有效申报价 848 元；合金支架上限由 848 元上调约 11.9% 至 949 元——信号是规则正从唯价向价值适度回调。
电刀，29 省联盟。 湖南牵头的省际联盟覆盖 29 个省区市及新疆生产建设兵团，于 2026 年 7 月 1 日落地，采购周期两年，总需求量超 2000 万把/片，市场规模超 35 亿元。17 个核心竞价组中，国产品牌包揽 16 组最低报价；分析估计外资电外科耗材份额（集采前超 50%）此后或降至 30% 以下。
更广的联盟活动。 “3+N”与省级联盟在 2026 年持续扩围：硬脑（脊）膜补片与留置针（天津牵头，3 月 11 日公布结果）、消化介入圈套器、外周血管约束型球囊与骨科冲洗系统（河北 3 月产品介绍）、以及覆盖 27–29 省的起搏器与外周微导管。清晰趋势：集采正成为器械目录的常态化商业环境。
可量化的替代。 对外资份额的影响很具体。消化介入圈套器领域，外资占比从约 45%（2020）降至 2025 年不足 25%，南微医学等国产将二级以上医院渗透率推过 70%。外周血管约束型球囊——长期由美敦力、雅培垄断——国产化率从 28%（2019）升至 2025 年约 58%，最新集采后有望破 70%，国产龙头乐普、惠泰、心脉抢占份额。外资仅在复杂高端细分仍具优势，但集采的量价逻辑持续压缩其可及市场。
为何本土化成为默认应对
面对集采降价与替代压力，越来越多外资器械企业正从”进口整机”转向”在华制造”。其逻辑既是商业也是运营。
爱尔博 VIO S CN 是 2026 年范本。 德国电外科龙头爱尔博（2026 年 1–5 月高频手术设备中标市占约 43.9%）此前整机自德国进口，承受漫长海运、跨境报关的高流通成本与长供货周期。其首台国产主机 VIO S CN——由中国团队深度参与、依托德国原装生产体系——于 2026 年 6 月 11 日获国家药监局注册证，7 月 1 日下线。本地生产压缩物流与进口成本，并显著提升供货响应，而这正是集采惩罚进口商的变量。
制造业现已放开。 2024 年版负面清单清空了制造业领域外资准入限制（2024 年 11 月 1 日施行），外商独资器械制造厂在华不再面临此前的行业上限。结合二类、三类器械的 NMPA 生产场地登记，外资可在中国建厂、登记场地，并为本地生产单品取得国产注册证——将”进口”转为集采意义上的”国产”。
规则现在奖励本地玩家的强项。 集采设计正从纯价格转向综合价值评价——技术介绍、临床论证、成本核验——为具备真实技术与规模的企业保留合理利润。本地生产是外资在价格、交期与供应稳定性上对标国产、同时保留原厂品质的最直接方式。
2026 年政策语境
- 创新优先。 《医疗器械监督管理条例》明确支持创新医疗器械优先审评审批，惠及本土与外资创新者将新产品推向市场。
- 制造业全面放开。 2024 年负面清单清除最后制造业限制，意味着器械制造在全国欢迎外商独资投资。
- 行动方案下的开放。 《利用外资固稳促优行动方案》（2026 年 7 月 1 日落地）重申亲外资立场，并支持药品分段生产、扩大生物技术与人独资医院试点等举措——这是外资器械企业所处的更宽政策背景。
外资器械集团下一步
- 按集采敞口映射产品组合。 将每个单品归类至是否属集采品类、替代风险高低、以及是溢价不可替还是走量价格敏感。
- 在可守处继续进口。 对临床差异化强、国产无同品种可比的高端器械，守住进口注册路线并保护溢价定位。
- 在走量处本土化。 对集采、价格敏感产线，自建或合同制造，向国家药监局登记场地并取得国产证，以集采条款竞争。
- 尽早敲定临床评价路径。 立项即决定同品种比对、免于临床或临床试验，以固定证据成本与时间表。
- 主动介入联盟。 跟踪河北、天津”3+N”、湖南、广东、浙江等省际联盟动向，准备支撑价值评价的技术介绍。
- 上市前备好中文标签、说明书与可追溯体系，并将国家药监局注册证视为清关关键单证。
常见误读
- 以为注册即准入。 越过国家药监局注册是必要非充分；决定销量的常是集采结果而非证书。
- 把整机进口进集采品类。 进口整机在集采价格与交期上无法对标本土化对手，必失份额。
- 忽视生产场地登记。 二类、三类境外生产企业须向国家药监局登记场地——规划本地生产时极易遗漏。
- 把集采当纯价格。 规则现已权衡技术与供应稳定性；价值陈述薄弱者即便价格有竞争力也会落败。
- 联盟介入太晚。 集采开标时分组与评价基本已定；影响它们需提前技术介绍。
来源
- 国家药品监督管理局（NMPA）——官方门户：https://www.nmpa.gov.cn
- 国家医疗保障局（NHSA）——集中带量采购：https://www.nhsa.gov.cn/
- 国务院新闻办发布会介绍利用外资固稳促优政策措施（2026-06）：https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm
- 国务院《利用外资固稳促优行动方案》（2026-06）：https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm
相关阅读
- 参见：医疗医药准入（药监局） / Healthcare & pharma market access (NMPA)
- 参见：医药产业开放新措施 / Pharma opening measures under the 2026 action plan