公告原文及官方解读：

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20250318152218159.html

https://www.nmpa.gov.cn/xxgk/zhcjd/zhcjdylqx/20250318152833181.html

政策背景与意义

国家药监局最新发布的2025年第30号公告，对2020年第104号公告进行了重要调整和优化，这是我国持续深化医疗器械监管改革的重要举措。此次调整的背景，一是贯彻党中央、国务院关于推进高水平对外开放的战略部署；二是全面落实2024年底国办发〔2024〕53号文件中关于促进医药产业高质量发展的要求。

此次政策调整的关键意义在于：通过扩大适用范围、优化注册流程和强化质量监管，进一步鼓励高端医疗器械产品在国内生产，这不仅有利于丰富国内医疗器械产品供应，更重要的是推动医疗器械产业链的本土化转型升级。

政策核心变化分析

一、适用范围的实质性扩大

最显著的变化是将适用主体从”进口医疗器械注册人设立的外商投资企业”扩展至”与进口医疗器械注册人具有同一实际控制人的企业”。这一调整基于《公司法》对实际控制人的界定，即”通过投资关系、协议或者其他安排，能够实际支配公司行为的人”。

这一变化意味着：更多类型的关联企业可以通过此通道在境内生产已获进口注册证的产品，大幅拓宽了政策受益面，有利于加速高端医疗器械的国内生产布局。

二、注册申报要求的精简优化

新政策保留了使用原进口注册资料的便利性，同时对申报要求进行了明确和细化：

1. 资料沿用范围明晰化：明确产品的综述资料、大部分非临床资料和临床评价资料可直接使用原进口产品资料，极大减少了重复性工作。
2. 关联关系证明要求具体化：对于共享实际控制人的情形，增加了提供股权关系说明和年度报告等佐证文件的要求，使关联关系认定更加规范。
3. 授权要求正式化：要求进口医疗器械注册人出具经公证的授权书，强化了知识产权保护意识。

三、注册体系核查的务实调整

1. 强调实质等同性：核查重点从形式合规转向实质等同性评估，特别关注产品设计开发环节，确保国内生产的产品质量与原进口产品保持一致。
2. 差异管理更加灵活：允许在合理范围内存在质量管理体系差异，但要求企业详细说明并确保不影响注册事项，同时做好风险分析和控制。

四、创新产品支持力度加大

新规明确提出对进口创新医疗器械产品在境内生产的，其注册、生产许可等事项优先办理，体现了政策对高端创新产品的倾斜。

此外，政策还首次明确了中国境内企业投资的境外注册人产品回流的路径，这对于支持我国企业的国际化发展具有积极意义。

政策影响与行业展望

对国际医疗器械企业的影响

1. 生产布局选择多元化：通过扩大适用主体范围，国际医疗器械企业可以采用更加灵活的方式安排在华生产，包括通过关联公司或合作伙伴在中国设立生产基地。
2. 技术转移成本降低：利用原注册资料开展境内注册申报，可大幅降低技术转移和本地化生产的时间和资源成本。

对国内医疗器械产业的影响

1. 产业链升级加速：通过引进高端产品在国内生产，将促进产业链上下游的协同发展和技术升级。
2. 创新能力提升：与国际先进技术的直接接触和吸收，将有助于提升国内企业的创新能力。
3. 医疗器械供应保障增强：更多高端医疗器械实现本土化生产，将增强供应链韧性，提高医疗器械的可及性和供应稳定性。

政策实施展望

从政策演进看，此次调整体现了监管部门对市场需求的积极回应和对产业发展的深刻理解。预计在政策实施过程中，可能会有以下几方面的积极变化：

1. 申报数量将显著增加：适用范围扩大和流程优化将带动更多进口医疗器械产品申请在华生产。
2. 高端产品转产加速：创新产品优先办理的政策将吸引更多高端医疗器械产品在国内转产。
3. 产业生态优化：随着更多国际先进技术和产品在国内生产，将进一步完善医疗器械产业生态。

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Catalyst for Medical Device Industry Localization: In-depth Analysis of NMPA Announcement No. 30

Policy Background and Significance

The National Medical Products Administration (NMPA) recently issued Announcement No. 30 of 2025, making significant adjustments and optimizations to the previous Announcement No. 104 of 2020. This represents an important step in China’s ongoing medical device regulatory reform. The background for these adjustments is twofold: first, to implement the central government’s strategic deployment of high-level opening-up policies; second, to fully implement the requirements for promoting high-quality development of the pharmaceutical industry as outlined in the State Council Office document No. 53 [2024].

The key significance of this policy adjustment lies in: expanding the scope of application, optimizing registration processes, and strengthening quality supervision to further encourage the domestic production of high-end medical devices. This not only helps diversify the domestic medical device product supply but, more importantly, promotes the localization and upgrading of the medical device industry chain.

Analysis of Core Policy Changes

I. Substantial Expansion of Scope

The most significant change is the extension of eligible entities from “foreign-invested enterprises established by imported medical device registrants” to include “enterprises that share the same actual controller as the imported medical device registrant.” This adjustment is based on the definition of “actual controller” in the Company Law, meaning “a person who can effectively control the company’s behavior through investment relationships, agreements, or other arrangements.”

This change implies that more types of affiliated enterprises can produce previously imported registered products domestically through this channel, substantially broadening the policy’s beneficiaries and accelerating the domestic production layout of high-end medical devices.

II. Streamlined Registration Requirements

The new policy maintains the convenience of using original imported registration materials while clarifying and refining submission requirements:

1. Clarified Scope of Material Reuse: Explicitly states that product summary materials, most non-clinical data, and clinical evaluation materials can directly use original imported product files, greatly reducing duplicative work.
2. Specific Requirements for Relationship Verification: For entities sharing the same actual controller, adds requirements for providing equity relationship explanations and annual reports as supporting documents, making the affiliation recognition more standardized.
3. Formalization of Authorization Requirements: Requires notarized authorization letters from imported medical device registrants, strengthening intellectual property protection awareness.

III. Practical Adjustments to Registration System Inspection

1. Emphasis on Substantial Equivalence: Shifts inspection focus from formal compliance to substantial equivalence assessment, with special attention to product design and development stages, ensuring domestic products maintain consistent quality with original imported products.
2. More Flexible Difference Management: Allows reasonable differences in quality management systems, but requires enterprises to provide detailed explanations ensuring no impact on registration items, while conducting risk analysis and control.

IV. Increased Support for Innovative Products

The new regulations explicitly prioritize registration and production licensing for imported innovative medical devices produced domestically, reflecting policy preference for high-end innovative products.

Additionally, the policy clarifies for the first time the pathway for repatriation of products from overseas registrants invested by Chinese domestic enterprises, which has positive implications for supporting the international development of Chinese companies.

Policy Impact and Industry Outlook

Impact on International Medical Device Companies

1. Diversified Production Layout Options: By expanding the scope of eligible entities, international medical device companies can adopt more flexible approaches to arrange production in China, including establishing production bases through affiliated companies or partners.
2. Reduced Technology Transfer Costs: Using original registration materials for domestic registration applications can significantly reduce the time and resource costs of technology transfer and localized production.

Impact on Domestic Medical Device Industry

1. Accelerated Industry Chain Upgrade: Introducing high-end products for domestic production will promote collaborative development and technological upgrading of upstream and downstream sectors in the industry chain.
2. Enhanced Innovation Capacity: Direct contact with and absorption of advanced international technologies will help improve the innovation capabilities of domestic enterprises.
3. Strengthened Medical Device Supply Assurance: More high-end medical devices achieving localized production will enhance supply chain resilience and improve the accessibility and stability of medical device supplies.

Policy Implementation Outlook

From the policy evolution perspective, this adjustment reflects the regulatory authorities’ active response to market demands and profound understanding of industry development. The following positive changes are expected during policy implementation:

1. Significant Increase in Applications: Expanded scope and optimized processes will drive more imported medical device products to apply for production in China.
2. Accelerated Transfer of High-end Products: The priority processing policy for innovative products will attract more high-end medical devices to transfer production domestically.
3. Optimized Industry Ecosystem: As more advanced international technologies and products are produced domestically, the medical device industry ecosystem will be further improved.

Policy Recommendations

1. Strengthen Supporting Guidance: Regulatory authorities should provide more detailed technical guidance documents on key issues such as actual controller identification and quality system difference management.
2. Optimize Evaluation Resource Allocation: With the expected significant increase in applications after policy implementation, timely adjustment of evaluation resource allocation is recommended to ensure evaluation efficiency.
3. Strengthen Policy Coordination: Enhanced coordination with relevant departments on finance, taxation, land use, and other areas is recommended to form a synergistic policy force supporting high-quality development of the medical device industry.