近年来，越来越多的跨国药品和医疗器械企业开始考虑在中国本地化生产，近年来大热的licensing许可交易当中也多半涉及到生产技术转移，以及伴随着进口产品将来国产化的问题。这一趋势既是受到成本控制与供应链管理的驱动，也契合中国鼓励产业本地化的政策导向。实现地产化的路径多样，可以是自建生产、合作生产或与本地合作伙伴开展合作（例如采用License-in或委托生产）等不同方式。与此同时，中国药械地产化的监管体系相对复杂且动态调整，企业在注册分类、申报资料、上市许可持有人（MAH）与生产安排、原研地位等方面常面临不小挑战。实践中，我们也频繁收到相关咨询。基于此，我们希望用本文与业界分享观察与思考。
In recent years, an increasing number of multinational pharmaceutical and medical device companies have been exploring local manufacturing options in China. Many of the licensing transactions that have surged in recent years also involve technology transfer and plans for the future localization of imported products. The trend is driven not only by the need for cost control and supply chain optimization but also aligns with China's policy incentives for industrial localization. Companies can pursue localization through various pathways, such as establishing their own production facilities, collaborating with contract manufacturers, or partnering with local licensees through licensing arrangements. However, China's regulatory framework for drug and medical device localization remains complex and constantly evolving. Companies often encounter challenges related to registration classification, application requirements, Marketing Authorization Holder (MAH) and manufacturing arrangements, as well as the recognition of originator drug status, etc. In practice, we frequently receive inquiries on these topics. Drawing from our experience and observations, this article aims to share key insights and perspectives to help navigate the evolving landscape.
一、进口药械地产化政策介绍
Policy Overview on the Localization of Imported Drug and Medical Device Manufacturing
（一）中国药械产品注册路径
Registration Pathways for Drugs and Medical Devices in China
目前，我国对进口药械产品与国产药械产品的监管路径有比较明显的区别：注册为进口产品的药械需要在境外生产，原则上由境外公司担任MAH，同时指定一家境内公司作为境内责任人/境内代理人；而注册为国产产品的药械则需要在境内生产，并由境内公司担任MAH。
In China, the regulatory pathways for "imported" and "domestic" drugs and medical devices are clearly differentiated. A product registered as "imported" must be manufactured overseas and is generally required to have a foreign company as the MAH, along with the designation of a local entity in China serving as the domestic responsible person or agent. By contrast, a product registered as "domestic" must be manufactured within China and is required to have a Chinese company as the MAH.
因此，由于进口与国产产品的注册路径不同，进口药械产品的本地化实质上属于"重新注册"，需要作为一款新的产品进行申报，而非简单的MAH或注册证的变更、转让。例如，对于进口创新药，重新注册后的产品需要按照我国仿制药的注册分类进行申报。不过，进口药械的本地化过程通常可享受注册资料简化等政策便利，同时在维持创新药地位方面仍存在一定潜在空间，具体内容将在后文讨论。
Therefore, given the distinct regulatory pathways for imported and domestic products, the localization of imported drugs and medical devices essentially constitutes a re-registration as a new product, rather than a simple amendment or transfer of the MAH or registration certificate. For instance, imported innovative drugs seeking localization must be submitted under China's generic drug classification. That said, the localization process often benefits from policy incentives, such as simplified registration documentation, and there may also be room to preserve certain benefits of originator status, as further discussed below.
（二）进口药品地产化监管要求
Regulatory Requirements for the Localization of Imported Drug Manufacturing
在进口药品地产化方面，过去，进口药品曾被允许通过申报补充申请的方式转至境内，但这一通道已废止。目前，进口药品从境外转至境内生产已不再允许通过转让完成，只能通过重新注册实现。2024年，国家药监局药审中心对于化学药和生物药分别发布了进口地产化的申报材料要求，为进口药品本地化的优化注册制度提供了更清晰的规范指引。
With regard to the localization of imported drugs, in the past, foreign manufacturers of imported drugs were permitted to transition production to China through a supplemental application. However, this pathway has since been discontinued. Currently, the transfer of manufacturing from overseas to China can no longer be completed via simple transfer and must instead proceed through re-registration. In 2024, the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) issued specific requirements for re-registration of imported chemical and biological products, thereby providing clearer regulatory guidance for the optimized registration pathway for localization.
根据现行法规，进口药品地产化适用优化注册制度的监管要点如下：
Under current regulations, the following are the key regulatory points for the optimized registration pathway for the localization of imported drugs:
- 申请主体：境内申请人均可，例如进口产品MAH的中国子公司或中国许可合作方。但如果境内申请人与进口产品的MAH或生产商属于同一总公司，可能适用更简化的申报资料要求。
- Applicant Requirements: any entity based in China is eligible to apply under the optimized registration pathway for localization, such as a Chinese subsidiary or licensing partners of the MAH of the imported drug; in cases where the domestic applicant shares the same parent company with the MAH or manufacturer of the imported product, documentation requirements may be further simplified.
- 申报要求：生物制品和原研化学药品的地产化可能适用简化申报要求，包括部分资料可免提供。原研药品的地产化亦可能纳入优先审评审批，适用更短法定审批时限。
- Application Requirements: the localization of biological products and originator chemical drugs may qualify for a simplified application process, with certain documentation exempted. Localization of originator drugs may also be eligible for priority review and approval under an expedited review timeline, as stipulated by law.
- 变更管理：为享受申报简化，建议地产药品与进口药品的生产工艺、处方组成、原辅料控制等均保持一致。但监管也允许地产产品的变更，如生产工艺或包装材料变更，需要按要求提供支持性资料。
- Management of Amendment Registration: to qualify for a simplified application process, it is recommended that manufacturing processes, formulation composition, and control of active pharmaceutical ingredients and excipients remain consistent between the localized and imported products. However, certain amendments – such as modifications to the manufacturing processes or packaging materials – are also permitted, provided that appropriate supporting documentation is submitted as required.
- 转让限制：进口药品应地产化转移至同一境内持有人，不得多次转移、分规格转移至不同境内持有人。
- Transfer Restrictions: an imported drug must be localized under one domestic MAH; multiple transfers or allocation of different product specifications to separate MAHs are not permitted.
- 生产安排：国产产品原则上需在境内生产。同时，近期国家及北京、上海等地方监管提出探索药械跨境委托生产和生物制品跨境分段生产制度，有望提升药品地产化安排的灵活性。目前实践中也已出现生物制品跨境分段生产的试点案例，我们也将持续关注进展（我们关于中国跨境委托生产和生物制品分段生产新政的解读文章，请见" 汉坤 " 观点 | 终于等到你——解读粤港澳大湾区药品医疗器械跨境委托生产新政"" 汉坤 " 观点 | 重磅：《生物制品分段生产试点工作方案》要点评析（中英双语）"。
- Manufacturing Arrangements: in principle, domestic products must be manufactured within China. Recently, both national regulators and local authorities in cities such as Beijing and Shanghai have proposed to explore cross-border contract manufacturing for drugs and devices, as well as segmented cross-border production of biological products, which is expected to enhance the flexibility of localization arrangements. In practice, pilot cases of segmented cross-border production for biological products have already emerged. We will continue to monitor these developments (for our analysis on China's new policies on cross-border contract manufacturing for drugs and devices and segmented production of biological products, please see "汉坤" 观点 | 终于等到你——解读粤港澳大湾区药品医疗器械跨境委托生产新政" and "Key Takeaways on China's Pilot Plan for Segmented Production of Biological Products").
（三）进口医疗器械地产化监管要求
Regulatory Requirements for the Localization of Imported Medical Device Manufacturing
在进口医疗器械地产化方面，我国也建立了配套的优化注册通道。国家药监局于2020年发布著名的"104号公告"为进口医疗器械的地产化开辟了优化注册通道，并于2025年发布文件（"30号公告"）调整相关规定。根据现行法规，进口医疗器械适用优化注册制度的监管要点如下：
China has also established an optimized registration pathway for the localization of imported medical devices. In 2020, the NMPA issued the landmark Announcement No. 104, which introduced an expedited route for medical device localization. In 2025, the NMPA further refined the regulatory framework through Announcement No. 30. Under current regulations, the key regulatory points for the optimized registration pathway for imported medical devices are as follows:
- 申请主体：与药品不同，进口医疗器械的地产化注册如果希望适用优化通路，对于申请主体在股权控制关系方面有较为严格的要求。
- Applicant Requirements: unlike in the cases of drugs, applicants seeking to utilize the optimized registration pathway for the localization of imported medical devices must meet stringent equity or controlling requirements regarding their relationship with prior MAHs.
- 产品范围：适用于第二类和第三类医疗器械，即对应风险等级相对高的注册分类的产品。
- Product Scope: the optimized registration pathway for imported medical devices is only applicable to Class II and Class III medical devices - products classified as higher-risk products under China's classification system.
- 变更管理：地产产品需要与进口产品的主要原材料、主要生产工艺不发生改变；质量管理体系需要"实质等同性"。
- Management of Amendment Registration: localized products must remain consistent with the imported product in terms of key raw materials and main manufacturing processes; their quality management system shall demonstrate "substantial equivalence" to that of the imported product.
- 优待政策：进口注册可以简化申报资料要求，进口创新医疗器械也可以优先办理注册、生产许可。地方政策也提供了更细的配套支持，例如上海市药监局近期发布新政提供简化注册申报资料与核查要求等制度优待。
- Favorable Policies: registration application for imported medical devices may be subject to simplified documentation requirements. Innovative imported medical devices may also qualify for priority review and expedited process for applying registration and manufacturing license. Local authorities have also introduced supporting measures - for example, the Shanghai Medical Products Administration recently issued policies offering streamlined documentation and inspection procedures.
- 生产安排：不得委托生产。根据实践经验，企业就该等医疗器械的委托生产安排需要慎重考虑并与药监部门充分沟通。
- Manufacturing Arrangements: contract manufacturing is not permitted. In practice, companies should carefully assess any contemplated contract manufacturing arrangements and engage in proactive communication with regulators before proceeding.
与药品无论注册类别均由国家药监局统一监管不同，国产医疗器械仅三类产品的注册由国家药监局负责，一、二类产品的备案和注册则由省级药监局负责。根据我们的实践经验，部分省级药监局可能支持医疗器械企业通过"普通程序"递交原进口注册资料实现优化办理。该等普通程序可能不要求申请主体符合前述严格持股/控制要求，也可能不涉及对委托生产模式的严格限制。
Unlike drugs, which are uniformly regulated by the NMPA regardless of their classification, domestic medical devices are subject to a tiered regulatory system in China: only Class III device registrations are overseen by the NMPA, while Class I and Class II device filings and registrations fall under the supervision of provincial-level medical products administrations. Based on our practical experience, certain provincial authorities may allow medical device companies to apply through the normal procedures while accepting previously filed documents for imported products to expedite the process. Such procedures may not require applicants to meet the equity or controlling requirements mentioned above and may also impose fewer restrictions on contract manufacturing arrangements.
二、进口药械地产化的攻略提示
Strategic Considerations for the Localization of Imported Drugs and Medical Devices in China
实践中，我们也经常收到进口药械企业的咨询，具体可能涉及项目架构、临床研发、许可交易、原研药品地位、境内药品注册分类、多项变更统筹管理等各方面，以下简要分析我们的观察和思考，供行业进一步参考。
In practice, we frequently receive inquiries from pharmaceutical and medical device companies on a range of issues related to localization, such as project structuring, clinical development strategies, licensing arrangements, originator drug status, registration classification, and the coordinated management of multiple amendment registrations. Below is a brief overview of our observations and key considerations for industry reference.
（一）地产项目合作架构
Collaboration Structuring for Localization Projects
进入中国市场，企业通常会考虑自建生产、与 CRO/CDMO合作、通过许可交易授权给中国合作伙伴等模式。不同模式在利益分配、风险承担、项目资产控制权及对合作方依赖度上各有特点。企业需结合自身情况综合判断，例如是否为小型初创生物科技企业、资金规模、是否已有合适合作方，以及对项目控制权和战略目标的要求等。
When entering the Chinese market, companies typically consider various models such as establishing their own manufacturing facilities, collaborating with CROs/CDMOs, or entering into licensing agreements with Chinese partners. Each approach entails different implications in terms of profit allocation, risk distribution, control over project assets, and reliance on partners. Companies need to conduct a comprehensive assessment based on their specific circumstances, such as whether it is a small startup biotech, its funding scale, existing partnerships, and its strategic objectives and desired level of control over the project.
（二）临床研发安排
Clinical Development Arrangements
我国的临床研究因其高效和优质而受到越来越多国际临床研发项目的青睐。值得注意的是，根据项目经验，药监部门目前不接受临床试验由境外申办方转让或变更给境内申办方，需要重新申请。在IND申报阶段，建议整体评估产品的定性和注册策略，以便高效推进产品上市。
Clinical study in China is increasingly favored in global clinical development programs due to its efficiency and high quality. It is important to note, however, that based on our project experience, the regulatory authority currently does not accept the transfer or amendment of clinical trial sponsorship from an overseas applicant to a Chinese applicant and would require a new application. Therefore, during the IND submission phase, it is advisable to comprehensively assess the product's development and registration strategy to ensure an efficient path to product approval.
此外，对于研究者发起的临床研究（IIT），企业参与过程中也需要关注人类遗传资源管理、个人信息和数据合规，以及潜在反腐败风险等监管要求。例如，在人类遗传资源监管要求下，境外企业是否适合寻求中国合作方对IIT项目进行资助。（关于人类遗传资源监管要点提示，请见我们的解读文章：" 汉坤 " 观点 | 重磅首发：〈人类遗传资源管理条例实施细则〉要点解读"" 汉坤 " 观点 | 新规速评：解读科技部最新人遗问答"" 汉坤 " 快评 | 〈人类遗传资源管理条例〉再次修订"；关于中国医药临床研究近期风险提示，请见我们的解读文章：" 汉坤 " 观点 | 医药临床研究风险高悬下的合规提示与应对建议（中英双语）"。
In addition, for investigator-initiated trials (IITs), companies need to pay attention to regulatory requirements regarding human genetic resources, personal information and data protection compliance, as well as the potential risk of violating anti-corruption regulations. For example, from the perspective of human genetic resources regulation, it is important to consider whether foreign companies should seek Chinese partners to fund IIT projects. (For key insights on human genetic resources regulatory requirements, please refer to our articles: "Highlights on HGR Regulation Implementation Rules" "Key Takeaways on the New HGR FAQs issued by the MOST of China" and "汉坤 " 快评 | 〈人类遗传资源管理条例〉再次修订" Regarding recent risk alerts in China drug clinical studies, please refer to our article: "Compliance Highlights and Strategies in High-Risk Clinical Research Landscape".)
（三）许可交易战略要点
Key Strategic Considerations for Licensing Transactions
在生命科学领域，技术转让和许可交易非常常见，且具有重要战略价值。我们在这类交易中有丰富经验，包括今年协助完成中国相关多项领先交易（我们关于许可交易项目的经验解读，请见《 2024年NewCo与药械License-in/out项目核心条款数据分析与对比》《 揭秘中国创新药企NewCo模式实战中的"六脉神剑"（中英双语）》《 药企出海新热点：管线分拆"SON"模式的实践解读》。此类协议通常较为复杂，需要通过细致谈判来保障公司的利益。
In the life sciences sector, technology transfer and licensing transactions are very common and hold significant strategic value. We have extensive experience advising on such transactions, including advising on several high-profile deals related to China this year (for our insights on licensing and NewCo transactions, please see "2024 Data Analytics: China Life Sciences NewCo & Licensing Terms" and "Six Key Insights into China Biotech's NewCo Model" and "Insights into China Biotech's New Approach: Spin-off-NewCo Model"). These agreements are typically complex and require careful negotiation to ensure the protection of company's interests.
对于利用许可交易推动进口药械地产化而言，合作双方都需要关注对于中国合作方勤勉义务、不竞争义务、项目决策权等关键事项的约定。例如，对于许可方而言，建议明确地要求合作方以具体勤勉义务标准积极推进产品开发，并避免其将资源转向其他产品，同时考虑保留对部分关键事项例如临床研究的决策权。
When using a licensing transaction as a vehicle to achieve the localization of imported drugs and medical devices, both parties involved should pay close attention to key provisions such as the Chinese partner's diligence obligations, non-compete commitments, and project decision-making rights. For example, licensors are advised to clearly define specific diligence standards requiring the partner to actively advance product development, prevent diversion of resources to competing products and consider retaining control over critical decisions, such as those related to clinical studies.
（四）原研药品地位
Originator Drug Status
创新药品有资格享受一系列政策优待，潜在的优待包括创新药身份、参比制剂、专利权与试验数据保护、商品名等各方面（关于中国药品试验数据保护制度最新进展，请见我们的解读文章：" 创新药交易新视角：评析药品试验数据保护制度新草案（中英双语）"）。根据中国的监管要求，进口创新药在地产化时需按照仿制药的注册分类进行注册，这可能会影响产品的原研地位。然而，地产产品作为进口创新药的地产版本，根据我们的经验，其原研待遇如参比制剂地位、商品名等在一定条件下可能得到部分保留，但具体情况仍需结合产品情况分析。
Innovative drugs are eligible for a range of policy incentives, including recognition as innovative drugs and reference formulations, the protections related to patent rights and clinical data, as well as the benefits related to brand names (for the latest developments on China's regulatory data protection system, please refer to our interpretive article: "Analysis of China's New Draft of Drug Regulatory Data Protection Rule: A New Perspective on Innovative Drug Transactions"). Under current China's regulations, imported innovative drugs undergoing localization must be registered under the generic drug classification, which may affect their originator drug status. However, based on our experience, certain aspects of such status – such as recognition as a reference formulation or retention of the brand names – may, in some cases, be preserved under certain conditions, although specific situations still need to be analyzed on a product-specific basis.
总体来看，我国关于地产产品原研地位的监管法规目前不完全明确，行业对此高度关注。我们也期待未来监管政策进一步完善，以更明确地认可地产产品的原研地位，从而推动更多优质药械产品在我国地产化。
Overall, China's regulatory framework regarding originator status for localized products is currently not entirely clear, and this issue continues to attract close attention from the industry. We also look forward to further regulatory clarification that would more clearly recognize the originator status of localized products, thereby promoting the localization of more high-quality drugs and medical devices in China.
（五）药械产品注册分类
China Registration Classification for Drugs and Medical Devices
创新药械在国内的注册分类可能与国外标准存在差异，企业需依据中国的注册分类进行判断，以确保注册路径的准确性。例如，部分新型药械组合产品在中国是否被视作药械组合，或需要作为药品和医疗器械分开注册，需参考法律法规、监管公示界定意见的先例，以及与监管部门的沟通，甚至可能需要申请界定。
For innovative drugs and medical devices, the registration classification in China may sometimes differ from that in foreign markets. Companies must determine the classification based on Chinese regulations to ensure accurate registration pathways. For instance, the regulatory categorization of certain novel drug-device combinations in China - whether they are classified as combined products, or as separate drug and medical device - may require reference to relevant laws, regulations interpretations, existing precedents, and consultation with regulators. In some cases, a formal classification request may also be necessary.
（六）多项变更的统筹管理
Coordinated Management of Multiple Amendment Registrations
在实践中，地产项目可能涉及药械集团间的资产收购或License-in的进口药械等不同情形，也可能同时涉及MAH变更、生产场地变更及API变更等多种情况。笔者曾参与并协助处理此类复杂变更，根据我们的项目经验，合理安排各项变更的顺序和时机，以及协调各类监管要求，也是确保项目顺利推进的关键。
In practice, localization projects may involve various scenarios, such as asset acquisitions within pharmaceutical or medical device groups, or license-in arrangements for imported drugs and medical devices. These projects often entail multiple concurrent amendment registrations, such as alteration of MAH, manufacturing site and active pharmaceutical ingredient (API). Based on our experience in assisting such complex amendment projects, it is crucial to carefully arrange the sequence and timing of various amendment registrations and to coordinate different regulatory requirements to ensure the smooth progress of the project.
结语
Conclusion
随着全球供应链格局的变化以及我国本地化政策的演进，药械地产化不仅是跨国企业优化成本与效率的选择，也正在成为深度融入我国市场、增强竞争力的重要契机。与此同时，监管要求和实施路径仍然复杂多变，企业在实践中常面临不小挑战。限于行文篇幅，本文仅能对部分核心监管要点作简要梳理，供行业参考。需要注意的是，药械地产项目的重点要点往往会因为产品特性和交易模式而有所差异，建议通过与企业内外部行业与法律专家的充分沟通，探索切实可行的合规路径。我们也将持续关注政策动态，与行业分享更多观察与思考。
As the global supply chain landscape constantly changes and China's localization policies advance, the localization of drugs and medical devices is increasingly viewed not just as a cost-efficiency measure, but as a strategic move for multinationals to strengthen their market presence and long-term competitiveness in China. However, the regulatory environment remains intricate and continuously evolving, posing significant implementation challenges. Given the scope of this article, we provide only a concise review of selected regulatory highlights. It is important to note that the critical considerations in such projects may differ based on product type and deal structure. We recommend that companies proactively consult with internal and external experts to develop feasible and compliant strategies. We will also continue to monitor policy developments closely and share more observations and insights with the industry.
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