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| Notice by Shanghai Municipal Administration for Market Regulation of Issuance of the Compliance Guidelines for Advertising Activities Regarding Medicinal Products, Medical Devices, Dietary Supplements and Formula Food for Special Medical Purposes in Shanghai Municipality | | 上海市市场监督管理局关于印发《上海市药品、医疗器械、保健食品、特殊医学用途配方食品广告活动合规指引》的通知 |
| No. 0308 [2025] of the Shanghai Municipal Administration for Market Regulation | | 沪市监广告〔2025〕0308号 |
| The administrations for market regulation of all districts; the Administration for Market Regulation of the Lin-gang Special Area; all divisions and offices, the Law Enforcement Team, and the Airport Branch of the Shanghai Municipal Administration for Market Regulation; the Shanghai Municipal Medical Products Administration; the Administrative Service Center and the Monitoring and Evaluation Center of the Shanghai Municipal Administration for Market Regulation; and all relevant entities: | | 各区市场监管局，临港新片区市场监管局，市局有关处室、执法总队、机场分局，市药品监管局，市局行政服务中心、监测评价中心，各有关单位： |
| For the purposes of further regulating the applications for censorship and the publishing of advertisements on medicinal products, medical devices, dietary supplements, and formula food for special medical purposes, strengthening the compliance guidance for advertisement applicants, and maintaining a good order of the advertising market, the Shanghai Municipal Administration for Market Regulation has developed the Compliance Guidelines for Advertising Activities Regarding Medicinal Products, Medical Devices, Dietary Supplements and Formula Food for Special Medical Purposes in Shanghai Municipality, which are hereby issued to you for your effective implementation in light of the actual circumstances. | | 为进一步规范上海市药品、医疗器械、保健食品、特殊医学用途配方食品广告审查申请及发布行为，加强对广告申请人的合规指导，维护良好的广告市场秩序，市局制定了《上海市药品、医疗器械、保健食品、特殊医学用途配方食品广告活动合规指引》，现印发给你们，请结合实际抓好贯彻落实。 |
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特此通知。 |
| Shanghai Municipal Administration for Market Regulation | | 上海市市场监督管理局 |
| November 13, 2025 | | 2025年11月13日 |
| Compliance Guidelines for Advertising Activities Regarding Medicinal Products, Medical Devices, Dietary Supplements and Formula Food for Special Medical Purposes in Shanghai Municipality | | 上海市药品、医疗器械、保健食品、特殊医学用途配方食品广告活动合规指引 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 (Purposes and basis) | | 第一条 （目的与依据） |
| For the purposes of further regulating the applications for censorship and the publishing of advertisements on medicinal products, medical devices, dietary supplements, and formula food for special medical purposes (hereinafter referred to as “three categories of products and medical devices”), maintaining the order of the advertising market, and protecting the lawful rights and interests of consumers, these Guidelines are developed in accordance with the Advertising Law of the People's Republic of China, the Interim Measures for the Administration of Censorship of Advertisements on Medicinal Products, Medical Devices, Dietary Supplements and Formula Food for Special Medical Purposes, and other laws and regulations in light of the actual circumstances of this Municipality. | | 为进一步规范上海市药品、医疗器械、保健食品、特殊医学用途配方食品（以下简称“三品一械"）广告审查申请及发布行为，维护广告市场秩序，保障消费者合法权益，根据《中华人民共和国广告法》《药品、医疗器械、保健食品、特殊医学用途配方食品广告审查管理暂行办法》等法律法规，结合本市实际，制定本指引。 |
| Article 2 (Scope of application) | | 第二条 （适用范围） |
| These Guidelines apply to the advertising activities engaged in by advertisers, advertising agents, advertisement publishers, and other entities conducting advertising activities within the administrative region of this Municipality. | | 广告主、广告经营者、广告发布者及其他广告活动主体在本市行政区域内从事“三品一械"广告活动，适用本指引。 |
| Article 3 (Responsibilities) | | 第三条 （主体责任） |
| Advertisers shall be responsible for the authenticity of the contents of advertisements on “three categories of products and medical devices,” and bear legal liability for their censorship applications and publishing of advertisements. | | 广告主应当对“三品一械"广告内容的真实性负责，并对审查申请、发布广告行为承担法律责任。 |
| Advertising agents and advertisement publishers shall, in accordance with laws and administrative regulations, check the Written Decision on Granting a License upon Advertisement Censorship and other relevant certification documents, and verify whether the contents of advertisements on “three categories of products and medical devices” are consistent with the advertisement samples that have passed the censorship. Advertising agents shall not provide design, production, and agency services for, and advertisement publishers shall not publish, advertisements with any inconsistent content or with incomplete certification documents. | | 广告经营者、广告发布者应当依据法律、行政法规查验《广告审查准予许可决定书》等有关证明文件，核对“三品一械"广告内容与审查通过的广告样件是否一致，对内容不符或者证明文件不全的广告，广告经营者不得提供设计、制作、代理服务，广告发布者不得发布。 |
| The administrator of a public place, an operator of telecommunications business, or an Internet information service provider shall stop the sending or publishing of illegal advertisements through its public place or information transmission or release platform that it knows or should have known. | | 公共场所的管理者、电信业务经营者、互联网信息服务提供者对其明知或者应知的利用其场所或者信息传输、发布平台发送、发布违法广告的，应当予以制止。 |
| An Internet platform operator shall monitor and investigate the contents of advertisements published by using its information services during the provision of Internet information services, and where any illegal advertisement is discovered, it shall stop the publishing of the advertisement by taking necessary measures such as notifying the violator to take corrective action, deletion, blocking, and disconnecting the link to the published advertisement. | | 互联网平台经营者在提供互联网信息服务过程中应当对利用其信息服务发布的广告内容进行监测、排查，发现违法广告的，应当采取通知改正、删除、屏蔽、断开发布链接等措施予以制止。 |
| Advertising industry organizations shall strengthen industry self-regulation, boost integrity building, and promote the sound development of the industry. | | 广告行业组织应当加强行业自律，推动诚信建设，促进行业健康发展。 |
| Chapter II Advertisement Censorship Compliance Requirements | | 第二章 广告审查合规要求 |
| Article 4 (Applicants for advertisement censorship) | | 第四条 （广告审查申请人） |
| The holders of registration certification documents or recordation certificates for “three categories of products and medical devices” and their authorized producers or traders are the applicants for advertisement censorship. | | “三品一械"注册证明文件或者备案凭证持有人及其授权的生产、经营企业为广告审查申请人。 |
| Applicants for advertisement censorship may authorize agents to handle matters concerning the applications for censorship of advertisements on “three categories of products and medical devices.” | | 广告审查申请人可以委托代理人办理“三品一械"广告审查申请。 |
| Article 5 (Advertisement censoring authorities) | | 第五条 （广告审查机关） |
| The advertisement censoring authorities in this Municipality are responsible for accepting applications for censorship of advertisements on “three categories of products and medical devices” submitted by production enterprises and import agents in Shanghai. | | 本市广告审查机关受理生产企业、进口代理人在上海的“三品一械"广告审查申请。 |
| Article 6 (Advertisement identification) | | 第六条 （广告认定） |
| Advertisements on “three categories of products and medical devices” are those that directly or indirectly introduce products under the “three categories of products and medical devices” via certain media and in certain forms, and relevant advertisements shall concurrently have characteristics such as marketing, media, non-specific audience, and non-compulsoriness. | | “三品一械"广告系利用一定的媒介和形式直接或者间接介绍“三品一械"产品，相关广告应当同时具备营销性、媒介性、受众不特定性、非强制性等特性。 |
| The following circumstances are generally not within the scope of commercial advertisements, without the need to apply for advertisement censorship: | | 以下情形一般不属于商业广告，且无需申请广告审查： |
| (1) Information such as an enterprise's name, abbreviation, trademark, logo, business scope, time of formation, development history, or enterprise profile is published within the enterprise's business premise or any other legally controlled area or on its self-built websites (web pages), or in Internet space that it has legal right to use, without directly or indirectly promoting commodities or services. | | （一）在企业经营场所及其他法定控制地带，或者在其自建网站（页）、拥有合法使用权的互联网空间发布企业名称、简称、商标、标识、经营范围、成立时间、发展历程、企业简介等信息，且未直接或者间接推销商品或者服务的； |
| (2) The information that is compulsorily required to be displayed, marked, or notified by laws, administrative regulations, departmental rules, compulsory national standards, or other relevant provisions issued by the state is published. | | （二）发布法律、行政法规、部门规章、强制性国家标准以及国家有关规定强制性要求展示、标示、告知的信息的； |
| (3) Products under the “three categories of products and medical devices” or their smallest packaging, instructions, labels, or installation (use) tutorials are displayed in the form of physical objects, pictures, or videos, among others, for the purpose of protecting consumers' right to information and right of choice. | | （三）为保障消费者知情权、选择权，以实物或者图片、视频等形式对“三品一械"产品或者产品的最小包装、说明书、标签、安装（使用）教程进行展示的； |
| (4) The information on enrollment of subjects subject to clinical trials of medicinal products, medical devices, or formula food for special medical purposes is issued upon approval by ethics review committees for the purpose of clinical trial research. | | （四）以临床试验研究为目的，经过伦理审查委员会批准后发布药品、医疗器械、特殊医学用途配方食品临床试验受试者招募信息的； |
| (5) The information on enrollment of subjects subject to human feeding trials of dietary supplements is issued upon approval by ethics review committees for the purpose of human feeding trial evaluation. | | （五）以人体试食评价为目的，经过伦理审查委员会批准后发布保健食品人体试食试验受试者招募信息的； |
| (6) Medical knowledge introduction or popular science publicity is conducted, without involving specific product information. | | （六）开展医药知识介绍、科普宣传且不涉及具体产品信息的； |
| (7) The face-to-face promotion of products under the “three categories of products and medical devices” is conducted through various on-site exhibitions, exhibition and spot sale, or display activities such as exhibitions, expositions, trade fairs, negotiation meetings, showcases, sales exhibitions, order meetings, new products releasing meetings, lectures, and promotion meetings, among others. | | （七）通过展览会、博览会、交易会、洽谈会、展示会、展销会、订货会、新品发布会、宣讲会、推介会等各类现场展览、展销和展示活动，对“三品一械"产品进行面对面推销的； |
| (8) The face-to-face promotion of products under the “three categories of products and medical devices” is conducted through offline meetings or in the form of on-site lectures or training, among others. | | （八）通过线下会议或者以现场讲座、培训等形式，对“三品一械"产品进行面对面推销的； |
| (9) Point-to-point instant information exchange is conducted through telephone, SMS, fax, or Internet instant messaging tools. | | （九）借助电话、短信息、传真、互联网即时通信工具进行点对点即时信息交流的； |
| (10) Products are promoted via Internet chat groups. | | （十）在互联网聊天群内推销产品的； |
| (11) Medical personnel provide relevant product usage advice to patients in the process of accepting consultation on Internet diagnosis and treatment platforms. | | （十一）医务人员在互联网诊疗平台接受咨询过程中，为患者提供相关产品使用建议的； |
| (12) Other circumstances that do not fall within the scope of commercial advertisements. | | （十二）其他不属于商业广告的情形。 |
| Article 7 (Filing of applications) | | 第七条 （申请行为） |
| An applicant for advertisement censorship shall truthfully submit relevant materials, file an application in a regulated manner, and meet the following requirements: | | 申请人申请广告审查，应当如实提交有关材料，规范申请行为，并符合下列要求： |
| (1) The applicant shall enter application items in an accurate and complete manner, and truthfully enter application category, advertising media, and other relevant information. | | （一）申请事项填报应准确完整，如实填报申请类别、广告媒介等； |
| (2) The applicant shall not apply for censorship of the same advertisement sample repeatedly at the stage of acceptance and censorship. | | （二）同一广告样件在受理审查阶段内不得重复申请； |
| (3) After receiving a notice of supplementation and correction, the applicant shall submit supplementation and correction materials on a one-off basis and in a complete manner within ten working days, and if the applicant fails to submit such materials during the specified period, it is deemed to have waived the application for advertisement censorship. | | （三）申请人收到补正通知后，应当按要求在10个工作日内一次性、完整提交补正材料，逾期未提交的，视为自动放弃广告审查申请； |
| (4) If the advertisement censoring authority legally refuses to accept the application for advertisement censorship filed by a specific applicant during a specified period in accordance with Articles 55, 57, 58, and 64 of the Advertising Law and other provisions, the relevant applicant shall file an application. | | （四）广告审查机关依据《广告法》第五十五条、第五十七条、第五十八条、第六十四条等规定，依法在一定期限内不予受理特定申请人的广告审查申请的，相关申请人不得提出申请。 |
| Article 8 (Requirements for materials) | | 第八条 （材料要求） |
| The certification materials related to advertisements on “three categories of products and medical devices” submitted by applicants shall be authentic, legal, and valid, and meet the following requirements: | | 申请人提交与“三品一械"广告相关的证明材料应当真实、合法、有效，并符合下列要求： |
| (1) Where authentic and valid product registration or recordation certification documents are provided, if product registration or recordation certification documents are modified, the latest valid certification documents shall be submitted. | | （一）提供真实有效的产品注册或者备案证明文件，产品注册或者备案文件发生变更的，应当提交最新的有效证明文件； |
| (2) If the submitted certification documents are in a foreign language, a Chinese translation consistent with the original in meaning shall be submitted, and the applicant shall be responsible for the authenticity and completeness of the translation. | | （二）提交的证明文件使用外国语言文字的，应当提交与原文意思一致的中文翻译版本，申请人对翻译版的真实性和完整性负责； |
| (3) If registered trademarks or patents are publicized, trademark registration certificates and patent certificates shall be provided. | | （三）宣传注册商标、专利的，应当提供商标注册证明、专利证明； |
| (4) Trademarks used in advertisements shall not infringe upon others' rights and interests in registered trademarks, and the registered trademarks and patents indicated shall be during the validity periods of the rights. | | （四）广告中使用的商标不得侵犯他人注册商标权益，标注的注册商标、专利应当在权利有效期限内； |
| (5) Where “Chinese time-honored brand,” “famous ancient classic prescriptions,” “XX years of heritage,” “XX0,000 Users,” etc. are used in promotion, valid certification documents shall be provided. | | （五）宣传“中华老字号"“古代经典名方"“XX年传承"“拥有XX万用户"等内容的，应当提供有效的证明材料； |
| (6) The legal and valid rights to use the character images, specific IPs, music lyrics, etc., used in advertisements shall be obtained. | | （六）广告中使用的人物形象、特定IP、音乐词曲等应当获得合法有效的使用权。 |
| Article 9 (Circumstances where censorship is not required) | | 第九条 （无需审查） |
| ．．．．．． | | ．．．．．． |
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