Analysis of the Advertising Compliance Guidelines for "Three Products and One Device" in Shanghai

On November 24, 2025, the "Compliance Guidelines for Advertising Activities of Drugs, Medical Devices, Health Foods and Special Medical Purpose Formula Foods in Shanghai" (hereinafter referred to as the "Guidelines") was released. This is the first systematic compliance guidance document formulated by Shanghai for the advertising campaign of "three products and one device". This guideline consists of five chapters and 27 articles, providing comprehensive regulations on advertisement review, content requirements, and release norms, and promoting Shanghai's supervision of "three products and one device" advertisements to enter a new stage of refinement. This article intends to analyze the key legal provisions of this guideline from the perspective of internal legal affairs management.

01. Set the background

The issuance of the "Guidelines" is related to the practical demands of the market. In recent years, new forms of advertising such as live-streaming sales, short video and slice promotion, and social media "seeding" have emerged in an endless stream. Traditional regulatory rules have certain difficulties in legal application. Some enterprises have problems such as exaggerating the efficacy, making false claims and engaging in illegal endorsements in their advertising and promotion, which infringe upon consumers' rights and interests and disrupt market order. For instance, the well-known Siming drug's draft of the "Famous People" [1]. The Guidelines are formulated in accordance with higher-level laws such as the Advertising Law and the Interim Measures for the Administration of the Review of Advertisements for Drugs, Medical Devices, Health Foods and Special Medical Purpose Formula Foods, aiming to regulate the application and release behavior of advertisements for "three products and one device", maintain market order and protect the rights and interests of consumers.

Analysis

As a normative document issued by the regulatory authority, the practical value of the "Guidelines" cannot be ignored. First, the "Guidelines" have a guiding significance in terms of the regulatory attitude towards new marketing formats, clearly stating expressions such as "It is not advisable to conduct marketing through online live streaming", and setting a warning line for the development of the industry. Second, the "Guidelines" adopt the legislative technique of "positive listing + negative list", which not only clearly defines twelve situations that do not require review but also lists prohibitive contents, providing enterprises with a clear compliance path. Thirdly, local guidelines are closely related to regional law enforcement practices and have unique value for understanding the regulatory stance of Shanghai.

02. Clarification of the criteria for advertising recognition

The Guidelines define four elements for the identification of advertisements: marketing (promoting goods or services), medium (released through certain media and forms), non-specific audience (communicating to unspecified objects), and non-coercive (the relative party can choose whether to accept or not). More importantly, the Guidelines list twelve situations where advertising review is not required, including: The release of basic information at business operation sites, the display of information as required by law, the display of physical products, the recruitment of clinical trial subjects, the popularization of medical knowledge, on-site promotion at exhibitions, promotion at offline conferences, point-to-point communication, promotion in chat groups, and suggestions from medical staff on Internet medical treatment platforms, etc.

Analysis

This definition holds significant practical significance. First, the four-element standards provide a basis for enterprises to self-examine the determination of advertisements, especially the "audience non-specificity" element, which excludes point-to-point sales, internal meetings and other behaviors from the scope of advertisements, leaving room for enterprises to conduct compliant marketing. Second, the listing of the twelve exemption scenarios reflects the scientific and practical nature of the regulation. In particular, the distinction between "medical knowledge popularization" and "advertising" is conducive to promoting relevant companies to conduct health education at their own expense. Thirdly, there is also a certain degree of ambiguity in the application of law enforcement in this definition, such as the boundary between "chat group promotion" and "social media seeding", and the upper limit of the number of people for face-to-face promotion, which may cause disputes in practice and need to be clarified in subsequent law enforcement practices.

03. Strict restrictions on the use of endorsers

The Guidelines clearly stipulate that advertisements for "three products and one device" shall not use advertising endorsers for recommendation or certification, and make determinations for four situations: First, indicating identity information in the advertisement and providing recommendation or certification for the product; Second, even if celebrities, Internet celebrities, experts, scholars and other public figures do not indicate their identities when making recommendation proofs, it still constitutes endorsement. Third, virtual digital humans or voices of celebrities or Internet influencers are regarded as the individuals themselves. Fourth, recommendations from advertisers and their staff are generally not recognized as endorsements. Demonstrations of products by individuals whose identities are difficult for the public to identify are generally regarded as advertising performances.

Analysis

This regulation deserves attention in three aspects. First, the virtual digital human clause is forward-looking. The possibility for enterprises to use AI technology to circumvent endorsement restrictions has decreased. However, it also poses higher compliance requirements for enterprises to use digital human technology. It is recommended that enterprises conduct a careful assessment before using any virtual image with the characteristics of a public figure. Second, the standard of "difficulty for the public to identify identities" provides enterprises with operational space. Enterprises can use non-public figures for product demonstrations, but they should be cautious to avoid behaviors that indicate or imply identities. Thirdly, this regulation conflicts significantly with the currently popular forms of marketing and promotion such as Kols and KOCs. Enterprises need to conduct a comprehensive review and adjustment of their existing marketing strategies. From the perspective of legal risks, it is recommended that enterprises use the spokesperson strategy (or brand endorsement) with caution in the marketing of "three products and one device", and instead adopt scientific argumentation, consumer education and other methods.

04. Regulatory Attitude towards Online Live-streaming Marketing

The Guidelines clearly state that "it is not advisable to market 'three products and one device' through live streaming on the Internet." In terms of the form of release, the Guidelines emphasize that advertisements should be recognizable and must not be released in a disguised form such as introducing health and wellness knowledge, nor in the form of news interviews or news reports.

Analysis

From the perspective of regulatory signals, the phrase "not advisable" actually conveys an attitude that enterprises should understand as "in principle, it should not be". This regulation has a profound impact on the industry: First, live-streaming sales, as one of the most mainstream marketing methods at present, are facing compliance difficulties in the "three products and one device" field, and enterprises need to reevaluate the configuration of marketing channels. Second, soft advertising forms such as product recommendation, review, and store exploration have been explicitly prohibited, which means that the marketing strategies of enterprises on platforms like Hongshu and Douyin may need to be comprehensively adjusted. Thirdly, this regulation may lead to regional differences in law enforcement standards. Whether other provinces and cities accept Shanghai's standards remains to be tested in practice.

05. Differentiation Requirements for four types of products

The Guidelines have respectively formulated significant labeling requirements and content norms for drugs, medical devices, health foods, and special medical purpose formula foods. Drug advertisements must prominently indicate the generic name, contraindications, and adverse reactions. Prescription drugs should be marked with "This advertisement is for reading by medical and pharmaceutical professionals only". The product name must not be promoted alone, and the expression "high cost performance" must not be used. Pharmacological effects must not be covertly promoted as efficacy. Medical device advertisements should prominently indicate the product name, contraindications or precautions. The physical display should be consistent with the registration certificate. They must not promote beyond the registered scope and must not covertly promote the mechanism of action as the intended use. Advertisements for health food products must prominently state that "health food is not medicine and cannot replace medicine in treating diseases", and must not imply product functions by means of the effects of ingredients. Advertisements for special medical purpose formula foods must prominently state "Use under the guidance of a doctor or clinical nutritionist", and must not covertly promote them as daily nutritional products.

Analysis

Differentiated regulation reflects the scientific nature of classified measures and also poses challenges to enterprise compliance. First, the requirements for prominent labeling of different product categories vary. When designing advertisements, enterprises must accurately grasp the product classification to avoid confusion. Second, there is considerable room for interpretation in regulations such as "pharmacological effects shall not be covertly promoted as efficacy" and "mechanism of action shall not be covertly promoted as intended use". It is suggested that enterprises strictly follow the instructions when describing their products and refrain from any promotion beyond the registered scope.

06. Application Materials and Modification Rules

The Guidelines put forward detailed requirements for the review of application materials: The supporting documents should be genuine and valid. Foreign languages need to be translated into Chinese. Proof should be provided for the promotion of trademarks and patents. Valid proof should be provided for the promotion of "Time-honored Chinese brands", "Ancient classic prescriptions", etc. Legal authorization should be obtained for the use of personal images, ips, music, etc. Enterprises with a record of illegal activities may lose their application qualifications for a certain period of time. For advertisements that have been reviewed and approved, the "Guidelines" clearly state that four types of changes do not require re-examination: adjusting the background color does not affect the visual effect, changing the font color does not affect the visual effect, adjusting the aspect ratio of the picture or switching between horizontal and vertical formats does not change the content expression, adding or changing the price, store address, contact information, delivery method, etc., and the changes must be true and accurate.

Analysis

The material requirements have raised the compliance requirements. First, the issue of material authorization is often overlooked by enterprises. It is recommended to establish a material archive management system, archive the authorization documents of each material, and pay special attention to the authorization period and scope. Second, special attention should be paid to the use of trademarks. The Guidelines prohibit the use of trademarks that contain claims of efficacy or safety, and the use of the words "well-known trademark". In practice, some enterprises' registered trademarks themselves contain efficacy implications. The use of such trademarks in advertisements needs to be carefully evaluated. The third and fourth modifiable scenarios offer flexibility to enterprises and represent regulatory innovations that adapt to the mobile Internet era. Fourth, the regulation restricting applications based on illegal records has strengthened the significance of enterprise compliance. A single violation may prevent an enterprise from conducting normal advertising activities for a certain period of time, which will have a significant impact on the enterprise's operation. [2]

07. Enterprise Response Strategies and Compliance Suggestions

Based on the above analysis, enterprises should improve their compliance systems from the following aspects: First, establish a multi-level review mechanism: the initial review by the Marketing Department (content completeness and material legality), the re-review by the legal department (legal compliance and risk assessment), and the final review by senior executives and people with different age groups, genders, ethnicities and other characteristics (strategic risk judgment, public order and good customs judgment). For innovative marketing methods, a special compliance assessment meeting should be held to prevent marketing decision-making deviations caused by the limitations of life experience or subjective judgment of some management teams.

Second, clearly define the red line for new media marketing. Suspend or proceed with caution the live-streaming sales business of "three products and one device" products. Conduct a comprehensive review of projects such as KOL cooperation, product seeding marketing, and store exploration promotion, and assess compliance risks. For new media activities that are indeed necessary to be carried out, it is essential to ensure that the content is strictly isolated from product promotion.

Third, reconstruct the material management system and establish a material compliance file to record the source, authorization scope, authorization period, and usage records of each material. For character images, it is necessary to clearly distinguish the boundaries between endorsement, performance and demonstration, and avoid using any character image that may be identified as an endorser. For trademarks, it is necessary to examine whether there are any implied effects. If necessary, trademark adjustments should be considered.

Fourth, strengthen dynamic compliance monitoring. Establish a reminder mechanism for the expiration of product registration certification documents. Once the certification documents are approaching expiration or change, immediately suspend the release of relevant advertisements. Establish a mechanism for early warning of illegal risks. For typical cases and law enforcement dynamics released by market supervision departments, organize timely learning and conduct self-examination in comparison. Establish an advertising effect tracking mechanism. For advertisements that may cause misunderstandings or trigger complaints, adjust or withdraw the materials in a timely manner.

Fifth, optimize the content expression strategy. Completely abandon traditional methods such as exaggerated promotion, efficacy hints, and intimidating marketing, and shift towards scientific education and consumer empowerment. For specific products such as prescription drugs, the target audience for dissemination should be strictly limited to avoid touching upon the taboos of mass communication.

08. Conclusion

The release of the "Guidelines" reflects the determination of regulatory authorities to strictly supervise advertisements for "three products and one device", and also provides clear guidance for enterprises to comply with regulations. Enterprises should recognize that the "Guidelines" are not only a normative document for Shanghai alone, but may also serve as a model for other regions to follow suit, which holds certain significance. Under the collision of new marketing formats and strict regulatory requirements, enterprises must abandon traditional marketing thinking, establish the concept of "compliance first", shift advertising compliance from post-event remediation to pre-event prevention, and from passive response to proactive management. Only in this way can business goals be achieved while ensuring compliance and sustainable development be maintained in the fierce market competition.