最新阅读
抢抓海外医疗器械蓝海！惠诚苏州涉外团队现场拆解巴基斯坦、东南亚准入与合规实操
国内医疗器械行业受集采政策影响，产能过剩、中小企生存承压，出海已成行业必然选择。东南亚、巴基斯坦市场需求爆发，但海外注册、外资准入、跨境合作暗藏多重法律风险。2026 年 7 月 3 日，医疗器械企业出海策略与海外市场法规专题分享会顺利举办。北京市惠诚（苏州）律师事务所国际业务合作部主任孙皓，携国际事务部门总监 Mohammad Dilnawaz virk 作为重磅嘉宾出席，围绕中巴医疗合作、东南亚器械准入、出海全链条合规风险展开干货分享，为参会器械企业带来一站式跨境法律落地解决方案。
On July 3, 2026, a special seminar themed Overseas Expansion Strategies for Medical Device Enterprises and Overseas Market Regulatory Rules was successfully held. Sun Hao, Director of the International Business Cooperation Department at Huicheng Law Firm (Suzhou Branch) and Mohammad Dilnawaz virk Director of the International Affairs at Huicheng Law Firm (Suzhou Branch), attended as a key guest. They delivered in-depth, practical sharing covering China-Pakistan medical cooperation, medical device market access in Southeast Asia and full-chain compliance risks in overseas expansion, providing participating medical device manufacturers with one-stop implementable cross-border legal solutions.行业现状
分享开篇，行业讲师梳理国内医疗器械行业痛点：医保集采挤压国内利润空间，行业集中度持续提升，中小器械企业生存压力陡增；反观海外市场，全球庞大人口叠加老龄化需求，2023-2025 年国内器械出口年均增速约 10%，2026 上半年增速持续走高。欧美、俄罗斯、印度为传统出口市场，以东盟为代表的东南亚市场快速崛起；RCEP 零关税、东盟 3.0 经贸框架实现监管互通，巴基斯坦依托中巴合作政策红利，成为两大核心增量赛道。孙皓主任现场指出：医疗器械出海是 “一把手工程”，企业普遍存在三大法律痛点：海外注册持证模式选择模糊、跨境合作权责无法律兜底、海外投资建厂 / 展会拓客缺乏本地化合规支撑，稍有疏漏便会出现技术泄露、证照失效、投资亏损等问题。
At the opening of the sharing session, the industry lecturer sorted out the pain points plaguing China’s medical device sector. Volume-based procurement under medical insurance has squeezed domestic profit margins while industrial concentration keeps rising, leaving small and medium-sized medical device enterprises under sharply mounting survival pressure. Moreover, overseas markets boast huge populations coupled with growing demand driven by aging populations. China’s annual export growth rate of medical devices stood at roughly 10% from 2023 to 2025, with growth accelerating further in the first half of 2026. Europe, the United States, Russia and India remain traditional export destinations, while Southeast Asian markets represented by ASEAN are emerging at a rapid pace. Thanks to zero-tariff provisions under RCEP and regulatory alignment under the ASEAN 3.0 economic and trade framework, plus policy dividends from China-Pakistan cooperation, Southeast Asia and Pakistan have become the two core growth tracks. Director Sun Hao pointed out on site that medical device overseas expansion is a "top leadership priority project". Enterprises generally face three major legal pain points: ambiguous choices over overseas registration and licensing models, lack of legal safeguards for rights and obligations in cross-border cooperation, and insufficient local compliance support for overseas factory investment and customer development via overseas exhibitions. Any minor oversight may trigger severe consequences including technology leakage, license invalidation and investment losses.惠诚苏州专题分享
本次分享核心板块，由国际业务合作部孙皓主任联合国际事务部门总监 Mohammad Dilnawaz virk 共同主讲巴基斯坦医疗市场投资与合规体系，结合中巴双边政策、当地监管规则、实操案例拆解完整出海路径：
1. 市场红利与政策优势
巴基斯坦总人口超 2.5 亿，全国医疗体系现代化升级，器械进口需求旺盛；中巴签署多项医疗领域合作协议，外资准入门槛持续放宽，本土技术合作项目可申领政府专项补贴，是现阶段布局南亚医疗器械的黄金窗口期。
2. 器械分级注册法律要求
巴方依据风险等级划分注册通道，法律流程差异显著：
-小型耗材、保健器械：简易进口销售许可，办理周期短；
-心脏支架、起搏器等中型器械：标准化申报流程快速获批；
-核磁、放疗大型设备：需完成本地临床核验或国内临床材料合规转化；放射性抗癌设备可享关税豁免、专项经营许可政策倾斜。
3. 惠诚全链条涉外法律服务能力
北京市惠诚（苏州）律所深耕涉外法律服务多年，联动巴基斯坦本土顶尖律所，打造双语中外律师协同服务模式，覆盖企业赴巴全流程法律需求：海外公司注册、医疗器械资质申办、进出口清关税务合规、跨境合作协议拟定、商事争议调解、本地采购资源对接等一站式服务。会后律所将在活动社群推送巴基斯坦医疗机构、采购企业合作名录，方便企业精准对接客源。
4. 重磅出海展会预告
孙皓主任现场重点推介两场高价值行业展会，律所全程提供法律配套支持：① 2026.7.16-7.18 卡拉奇・中巴医药医疗峰会：巴政府承担参会食宿，律所代办使馆官方邀请函，一周内快速办结签证，现场对接上百家本地采购商；报名通道开放至本周结束，意向企业可联系我所咨询报名。② 2026 年 8-9 月三场美国专业医疗展会：分别于八月初、八月中旬、九月底举办，律所提前匹配当地采购资源，同步提供美、加、英、中国香港等多地跨境投资合规法律服务。
The core session of the sharing event was jointly delivered by Director Sun Hao of the International Business Cooperation Department and foreign cooperating lawyer Muhammad, focusing on investment and compliance systems in Pakistan’s medical market. Combining bilateral China-Pakistan policies, local regulatory rules and practical cases, they broke down the complete overseas market entry roadmap.
1. Market Dividends and Policy Advantages
Pakistan has a total population of over 250 million, with its nationwide healthcare system undergoing modernization upgrades, generating robust demand for imported medical devices. China and Pakistan have signed multiple cooperation agreements in the medical sector, with continuously lowered market access thresholds for foreign capital. Local technical cooperation projects are eligible for special government subsidies, making the current period a prime window for medical device enterprises to deploy businesses across South Asia.
2. Legal Requirements for Graded Medical Device Registration
Pakistan adopts classified registration channels based on product risk levels, with drastically different legal procedures for each category:
Small consumables and healthcare devices: Simplified import and sales licenses with short processing cycles.
Medium-risk devices such as cardiac stents and pacemakers: Standardized application procedures for speedy approvals.
Large-scale equipment including MRI and radiotherapy machines: Mandatory local clinical verification or compliant conversion of domestic clinical documentation. Radioactive anti-cancer equipment enjoys tariff exemptions and preferential policies for special operation licenses.
3. Full-Spectrum Foreign-Related Legal Services of Huicheng Law Firm
Huicheng Law Firm (Suzhou Branch), Beijing has years of experience in cross-border legal services. It collaborates with top-tier local law firms in Pakistan to deliver coordinated bilingual legal services by Chinese and overseas lawyers, covering all-round legal needs for enterprises investing in Pakistan. Our one-stop service portfolio includes overseas company registration, medical device qualification application, customs clearance and tax compliance for import and export, drafting cross-border cooperation agreements, commercial dispute mediation, and matching local procurement resources. After the seminar, the firm will share a directory of Pakistani medical institutions and purchasing enterprises in the event group chat to facilitate precise business matching for participants.
4. Preview of Key Overseas Medical Exhibitions
Director Sun Hao highlighted two high-value industry exhibitions, with full legal supporting services provided by our firm:① China-Pakistan Pharmaceutical & Medical Summit (Karachi, July 16–18, 2026): The Pakistani government covers accommodation and meals for attendees. Our firm assists with official embassy invitation letters and expedites visa processing within one week, enabling on-site connections with hundreds of local buyers. Registration closes by the end of this week; interested enterprises may contact our firm for sign-up consultation.② Three professional medical exhibitions in the United States (August–September 2026): Scheduled for early August, mid-August and late September respectively. Our firm will pre-match local procurement resources and provide cross-border investment compliance services covering the U.S., Canada, the UK, Hong Kong of China and other regions.
东南亚市场合规要点补充
本次分享同步邀请法规专家解读东盟市场准入规则，孙皓主任结合涉外法律服务经验，补充东南亚出海法律注意事项：东盟 11 国人口持续增长、医疗设备更新需求旺盛，东盟六国占据区域 96% 市场份额，越南、泰国、印尼器械出口额均突破十亿美元。但马、泰两国对器械注册证书归属、转让有严格监管要求，企业选择代理商持证、自建主体、第三方持证三种模式各存法律隐患。孙皓律师提示企业：出海前期务必由涉外律师介入合作合同拟定，明确注册权属、退出机制、知识产权保护条款，规避代理商控盘、技术外泄、持证无法销售等常见纠纷；筛选海外 CRO 机构时，需核查档案主体、持证代表、报价体系，杜绝隐形收费与服务断层。
Regulatory experts were also invited to interpret ASEAN market access rules during the seminar. Drawing on extensive experience in cross-border legal services, Director Sun Hao supplemented key legal precautions for medical device companies expanding into Southeast Asia.
The 11 ASEAN member states boast steadily growing populations and strong demand for medical equipment renewal. Six core ASEAN countries account for 96% of the regional market share, with Vietnam, Thailand and Indonesia each recording medical device export volumes exceeding one billion US dollars. Nevertheless, Malaysia and Thailand impose stringent regulatory restrictions on the ownership and transfer of medical device registration certificates. The three mainstream market entry models—authorizing agents to hold registrations, establishing local corporate entities independently, and entrusting third parties with registration certificates—each carry distinct legal risks.
Lawyer Sun reminded participating enterprises that cross-border lawyers must be involved in drafting cooperation contracts at the early stage of overseas expansion. Contracts should clearly stipulate registration ownership, exit mechanisms and intellectual property protection clauses to prevent common disputes such as agent monopoly, technology leakage, and sales bans caused by registration ownership issues. When selecting overseas CRO institutions, companies need to verify institutional legal status, authorized registrants and quotation systems to avoid hidden charges and disrupted service delivery.
结语：
国产医疗器械出海机遇与风险并存，合规是企业深耕海外市场的长期底盘。北京市惠诚（苏州）律师事务所国际业务部将持续搭建 “中国企业 + 海外本地法律资源” 服务桥梁，以中外联合律师团队专业能力，护航医疗器械企业安全出海、深耕全球市场。
Conclusion
Overseas expansion of domestic medical devices comes with both promising opportunities and potential risks, and compliance serves as the long-term foundation for enterprises to cultivate overseas markets in depth.
The International Business Department of Huicheng Law Firm (Suzhou Branch), Beijing will continue to build a service bridge linking Chinese enterprises with local overseas legal resources. Relying on the professional expertise of its joint Chinese and foreign lawyer team, the department will safeguard medical device manufacturers in their secure global expansion and sustained development across worldwide markets.
▍版权声明：
○ 本文中图片及文字内容为原创作品，版权归北京市惠诚（苏州）律师事务所所有，未经授权，严禁转载、引用或用于任何商业用途。
○ 部分图片及文字内容如有来源于网络，仅作非商业用途的分享与交流。如涉及版权问题，请著作权人提供相关权利证明联系我方，我方将及时核实并删除。
○ 感谢您的支持与理解。
