China professionalises the hospital channel for medical-nutrition foods: the FSMP Guiding Opinions
- In late August 2026, the National Health Commission (NHC) and SAMR jointly issued the Guiding Opinions on Regulating the Use of Foods for Special Medical Purposes (FSMP) in Medical Institutions (document 国卫办食品发〔2026〕11号, dated 6 August 2026).
2026年8月下旬，国家卫生健康委办公厅与市场监管总局办公厅联合印发《关于规范医疗机构特殊医学用途配方食品使用的指导意见》（国卫办食品发〔2026〕11号，成文日期2026年8月6日），面向各级各类医疗机构。
- The Opinions define FSMP as formula foods registered by SAMR for sale on the domestic market, formulated for people with restricted eating, digestive-absorption disorders, metabolic disorders or specific disease states, and require use under the guidance of a physician or clinical nutritionist.
指导意见界定：特医食品是指经国家市场监管部门注册可以在国内市场销售、为满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要专门加工配制的配方食品，须在医师或临床营养技师指导下使用。
- Medical institutions must set up a dedicated FSMP management department or group, maintain a dynamic internal supply catalogue admitting only SAMR-registered products, and centralise selection, procurement, use and charging.
医疗机构须确立特医食品使用管理部门或小组，建立并动态调整本机构《特殊医学用途配方食品供应目录》，只允许经国家注册的特医食品进入目录，并对遴选、采购、使用、收费进行集中统一管理。
- Within hospitals, FSMP must be sold in a clearly marked dedicated zone or counter (“特殊医学用途配方食品销售专区/专柜”), sale and usage information must be recorded and retained to medical-record standards, and FSMP must not be prescribed as medicine — it is not a drug, so no prescriptions, and billing must be separated from pharmaceuticals.
院内管理上，特医食品须设专区专柜销售并显著提示；销售信息（含患者信息、品名、规格、价格）记录保存时限参照病历；特医食品不属于药品、不得开具处方，发放与收费须与药品区分。
- For imported and domestic FSMP producers and their distributors, the guidance professionalises the hospital channel: registration status will be verified at the hospital gate, procurement and recall co-operation with institutions is formalised, and marketing into hospitals must shift from prescription-style promotion to compliance-based clinical-nutrition education.
对国内外特医食品企业与经销商而言，新规使医院渠道走向专业化：注册资质在医院门口被核验，采购与召回配合被制度化，面向医院的推广须从”类处方”促销转向合规的临床营养教育。
China professionalises the hospital channel for medical-nutrition foods: the FSMP Guiding Opinions | 特医食品医院渠道走向规范化：两部门出台医疗机构使用指导意见
Overview
The National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) jointly issued the Guiding Opinions on Regulating the Use of Foods for Special Medical Purposes (FSMP) in Medical Institutions (《关于规范医疗机构特殊医学用途配方食品使用的指导意见》) in late August 2026, with the document dated 6 August 2026 and publicised around 26–30 August. The Opinions, issued under the Food Safety Law and the Regulations on the Administration of Medical Institutions, apply to the selection, sale and use of FSMP within all types and levels of medical institutions in China. They mark the first time the national authorities have set out a complete operational framework for how hospitals should manage, stock, sell and use FSMP — a category that sits at the intersection of food, nutrition and clinical care.
What FSMP are — and why they need special rules
FSMP are formula foods that have been registered by SAMR for sale on the domestic market, specially processed and formulated to meet the nutritional or dietary needs of people with restricted eating, digestive or absorption disorders, metabolic disorders, or specific disease states. They provide important nutritional support for treatment, rehabilitation and maintenance of bodily function in these populations. Because they look like medical products but are legally food, they have historically sat in an ambiguous zone: food law governs their registration, yet their practical use is clinical, and hospitals have lacked uniform rules on procurement, pricing, storage and use.
The Opinions restate the fundamental boundary: FSMP must be used under the guidance of a physician or clinical nutritionist, and they are not drugs. The document applies to medical institutions holding a Medical Institution Practicing Licence or clinic-filing certificate.
Three layers of institutional rules
1. Governance structure. Each medical institution must establish a dedicated FSMP management department or group, build and dynamically adjust its own internal FSMP supply catalogue, verify product qualifications, and admit only FSMP registered by SAMR. The institution must set up rules for selection, review, procurement, use, periodic evaluation and exit, managing FSMP centrally and standardising the processes for receiving, using and charging.
2. In-hospital management systems. Institutions must take effective control measures across procurement, storage, sale and use; establish and refine systems for incoming-goods inspection and record-keeping (进货查验记录制度), warehouse management, in-and-out management, and handling of non-conforming FSMP; and designate personnel responsible for food-safety management. Practitioners involved in FSMP use — physicians or clinical nutritionists — should have clinical-nutrition education or training, plus FSMP-use knowledge and standardised-management training.
3. Clinical-use discipline. Practitioners should follow a standardised nutrition-diagnosis-and-treatment pathway, giving priority to dietary guidance and only proposing FSMP where dietary intervention cannot meet clinical needs and there are clinical indications. When recommending FSMP, they should explain the product’s details and its non-drug nature, whether alternative food or medicine exists, and obtain patient or family consent where used. FSMP use during a hospital stay should be recorded in the medical record, and the institution’s FSMP management department or group should evaluate the standardisation and reasonableness of use.
Selling and charging rules that matter commercially
Four operational rules are particularly important for producers and distributors:
- Dedicated zone or counter. Institutions that sell FSMP must set up a separate sales area with a prominent sign reading “特殊医学用途配方食品销售专区（或专柜）”.
- Record retention. Sales information — including patient information, FSMP name, specification and price — must be recorded and kept for a retention period consistent with medical records. This is a significant compliance consideration under the Personal Information Protection Law for patient-related data.
- No prescriptions; separate billing. FSMP are not drugs, so they cannot be prescribed; their distribution and charging must be separated from pharmaceuticals. Institutions are encouraged to adopt information-system coding management that brings FSMP sales and use into hospital information systems.
- No coercion. It is prohibited to sell or use, in the name of FSMP, any food that is not registered or that implies it can meet the special nutritional or dietary needs of the target populations. It is also prohibited to force or induce patients to buy FSMP in the institution or at designated outlets.
Recall co-operation
Institutions must co-operate with FSMP producers on recalls: once aware that a producer is recalling unsafe FSMP, the institution must immediately stop selling and seal the product and post a recall notice in a prominent position. Producers should therefore ensure their recall procedures reach hospital customers promptly and are documented.
What this means for producers and distributors
- Registration is the admission ticket to the hospital channel. Hospitals may only list SAMR-registered FSMP in their supply catalogues. For importers, this reinforces the existing requirement to hold a Chinese registration for each product sold in China; products without registration cannot legally enter the hospital channel regardless of clinical demand.
- The path to hospital formulary entry is now formal. Producers should expect hospital procurement to be run through the dedicated management group, with qualification review, and periodic re-evaluation. Building clinical-nutrition evidence and co-operation with nutrition departments — rather than prescription-oriented promotion — becomes the compliant route to market access.
- Compliance burden moves down the chain. Distributors serving hospitals must ensure that labelling, storage and delivery meet the dedicated-zone and traceability expectations, and that patient-related sales data handling complies with privacy rules.
- Regional variation is expected. The Opinions acknowledge that regions differ in economic development, medical-resource allocation and clinical-nutrition development, and encourage local implementation adapted to local conditions. Producers should track provincial implementation measures.
- Opportunity in the nutritional-support gap. With an ageing population and growing awareness of clinical nutrition, FSMP remain a growth category; clearer rules that professionalise the hospital channel can favour compliant, well-evidenced brands — domestic and foreign alike.
Practical steps
- Verify that every FSMP product marketed into China holds a valid SAMR registration matching the exact formula and label in use.
- Prepare hospital-facing materials that support nutrition-department education and formulary review (clinical evidence summaries, usage guidance compliant with non-drug positioning).
- Ensure recall plans include hospital customers and rapid notification mechanisms.
- Review distributor agreements for compliance with dedicated-zone sale, record-retention and no-coercion rules.
- Monitor provincial implementation guidance and adjust sales models per region.
Sources
- 市场监管总局 — 国家卫生健康委办公厅 市场监管总局办公厅关于规范医疗机构特殊医学用途配方食品使用的指导意见（全文）: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2026/art_81290de7385d4573939b6790103a5fb1.html
- 市场监管总局（新闻）— 两部门联合出台指导意见 规范医疗机构使用特殊医学用途配方食品: https://www.samr.gov.cn:8007/xw/zj/art/2026/art_b34e6b283ecf4530a93aef63c6194e9f.html
- 毕节市人民政府（政策解读转载）— 划红线、建目录、禁开处方！国家出台新规规范特医食品使用: https://www.bijie.gov.cn/bm/bjswsjkj/zwgk/zcwjjjd/202608/t20260831_90801118.html
- 人民网湖北频道 — 国家卫生健康委等规范医疗机构特医食品使用管理: https://hb.people.com.cn/n2/2026/0831/c192237-41681914.html
Related reading
- see also: China’s FSMP registration regime — the 2024 Administrative Measures baseline (fsmp-registration-measures)
- see also: medical-device and pharma market entry routes into Chinese hospitals (healthcare-market-access)
特医食品医院渠道走向规范化：两部门出台医疗机构使用指导意见
概述
2026年8月下旬，国家卫生健康委办公厅与市场监管总局办公厅联合印发《关于规范医疗机构特殊医学用途配方食品使用的指导意见》（成文日期2026年8月6日，8月26日前后对外发布）。指导意见依据《食品安全法》《医疗机构管理条例》等法律法规制定，适用于各级各类医疗机构内特医食品的遴选、销售与使用，是国家层面首次为医院如何管理、采购、销售和使用特医食品建立完整操作框架。特医食品正处于食品、营养与临床照护的交叉地带，此前的管理长期存在模糊区。
什么是特医食品——以及为何需要专门规则
特医食品是指经国家市场监管部门注册可以在国内市场销售，为满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要，专门加工配制而成的配方食品。对这些人群的治疗、康复及机体功能维持起着重要营养支持作用。它看起来像医疗产品、法律上却是食品：注册环节适用食品法，实际使用却是临床行为，医院在采购、定价、储存与使用上长期缺乏统一规则。
指导意见重申根本边界：特医食品须在医师或临床营养技师指导下使用，且不属于药品。文件适用于持有《医疗机构执业许可证》或诊所备案凭证、依法从事疾病诊断和治疗活动的诊疗机构。
三层制度要求
一、治理架构。 医疗机构须确立特医食品使用管理部门或小组，建立并动态调整本机构《特殊医学用途配方食品供应目录》，审核产品资质，只允许经国家市场监管部门注册的特医食品进入目录。医院要建立遴选、审核、采购、使用、定期评估和退出制度，对特医食品集中统一管理，规范领取、使用与收费流程。
二、院内管理制度。 医院须在采购、贮存、销售及使用等环节采取有效控制措施，建立健全进货查验记录制度、仓储场所管理制度、出入库管理制度及不合格特医食品处置制度，明确负责食品安全管理的人员。从事特医食品使用工作的医师或临床营养技师等，应经过临床营养专业教育或培训，以及特医食品使用知识和规范化管理培训。
三、临床使用规范。 医师或临床营养技师应严格遵照规范化营养诊疗流程，优先提出膳食指导建议；膳食干预无法满足临床需求时，方可根据临床应用指征提出必要的特医食品使用建议。提出建议时应说明食品详情和非药品属性、是否有可替代的食品或药品，使用应征得患者或家属同意。患者住院期间使用特医食品的情况应记入病历，医院特医食品使用管理部门或小组应组织评估使用规范性与合理性。
对商业运营至关重要的销售与收费规则
以下四项操作性规则对生产企业和经销商尤其关键：
- 专区专柜。 医疗机构经营特医食品，应设专门的销售区域，显著位置设提示牌，注明”特殊医学用途配方食品销售专区（或专柜）”字样。
- 信息留存。 对销售信息（含患者信息、特医食品名称、规格、价格）进行记录和保存，保存时限参照病历。涉及患者信息的数据处理须同时符合《个人信息保护法》等要求。
- 不得开处方、收费分离。 特医食品不属于药品、不得开具处方，其发放、收费等应当与药品区分；鼓励有条件的机构做好信息业务编码管理，将特医食品销售和使用项目纳入院内信息系统。
- 禁止强制销售。 严禁以特医食品名义销售或使用未经国家注册批准、明示或暗示可用于满足目标人群特殊营养或膳食需要的食品；严禁强制或诱导患者在本机构或到指定地点购买。
召回配合
医疗机构应配合特医食品生产企业开展召回：一旦知悉企业召回不安全特医食品，应立即停止销售并封存、在醒目位置张贴召回公告。生产企业应确保召回程序能及时触达医院客户并留存记录。
对企业与经销商的意义
- 注册资质是进入医院渠道的门票。 医院目录只接纳经国家注册的特医食品。进口商须为在华销售的每个产品持有有效中国注册证；无注册证的产品无论临床需求多大都无法合法进入医院渠道。
- 进入院内目录的路径正式化。 生产企业应预期采购由专门管理小组按资质审核与定期再评估流程运作。建立临床营养证据、与营养科开展合规合作，而非”类处方”式促销，成为合规的市场准入路径。
- 合规压力沿渠道下移。 服务医院的经销商须确保标签、储存与配送满足专区与可追溯预期，涉患者销售数据的处理符合隐私规则。
- 地区差异可期。 指导意见承认各地在经济发展水平、医疗资源配置与临床营养学科建设上存在差异，鼓励各地结合本地实际实施。企业应跟踪省级落实细则。
- 营养支持缺口中的机遇。 在人口老龄化与临床营养意识提升背景下，特医食品仍是增长品类；医院渠道专业化的清晰规则，将有利于合规、有证据的国内外品牌。
实务建议
- 核验在华销售的每个特医食品产品均持有与在用配方、标签一致的有效的国家注册证。
- 准备面向医院的合规材料，支持营养科教育与目录评审（临床证据摘要、符合非药品定位的使用指引）。
- 确保召回计划覆盖医院客户并具备快速通知机制。
- 审查经销商协议，确保其遵守专区销售、记录留存与禁止强制销售规则。
- 跟踪各省级实施指引，分区域调整销售模式。
来源
- 市场监管总局 — 国家卫生健康委办公厅 市场监管总局办公厅关于规范医疗机构特殊医学用途配方食品使用的指导意见（全文）: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2026/art_81290de7385d4573939b6790103a5fb1.html
- 市场监管总局（新闻）— 两部门联合出台指导意见 规范医疗机构使用特殊医学用途配方食品: https://www.samr.gov.cn:8007/xw/zj/art/2026/art_b34e6b283ecf4530a93aef63c6194e9f.html
- 毕节市人民政府（政策解读转载）— 划红线、建目录、禁开处方！国家出台新规规范特医食品使用: https://www.bijie.gov.cn/bm/bjswsjkj/zwgk/zcwjjjd/202608/t20260831_90801118.html
- 人民网湖北频道 — 国家卫生健康委等规范医疗机构特医食品使用管理: https://hb.people.com.cn/n2/2026/0831/c192237-41681914.html
相关阅读
- 见：中国特医食品注册管理——《注册管理办法》（2024年施行）基线（fsmp-registration-measures）
- 见：药品与医疗器械进入中国医院市场的路径（healthcare-market-access）