On December 24, 2019, the State Administration for Market Regulation issued the Interim Measures for the Review and Administration of Advertisements for Drugs, Medical Devices, Health Food and Formula Food for Special Medical Purposes (hereinafter referred to as the Interim Measures). The "Interim Measures" will come into effect from March 1, 2020, and at the same time the original "Medical Device Advertising Review Measures" and "Medical Device Advertising Review and Release standards" will be repealed at the same time. The compliance of medical device advertising mainly includes three aspects, namely, the compliance of advertising release process, the compliance of advertising content and the compliance of advertising form. This article combines the relevant provisions of the "Interim Measures" and the "Advertising Law of the People's Republic of China" (hereinafter referred to as the "Advertising Law"), and discusses the compliance issues in three aspects of medical device advertising for operators' reference.

First of all, what is advertising? In the Advertising Law, advertising refers to commercial advertising activities in which commodity operators or service providers directly or indirectly introduce the commodities or services they sell through certain media and forms within the territory of the People's Republic of China. In July 2016, the State Administration for Industry and Commerce issued the "Interim Measures for the Administration of Internet Advertising", which describes the extension of the concept of Internet advertising: it refers to the commercial advertising that directly or indirectly promotes goods or services through Internet media such as websites, web pages, Internet applications, in text, pictures, audio, video or other forms. Advertisements in the form of text, pictures or videos containing links to promote goods or services; E-mail advertisements promoting goods or services; Paid search advertising to promote goods or services; For advertisements in commercial displays promoting commodities or services, the display of information required by laws, regulations and rules to be provided by business operators to consumers shall be in accordance with such provisions; Other commercial advertisements promoting goods or services through Internet media. It can be seen that the soft advertising on the media, forum advertising posts, wechat circle of friends, wechat public number, and marketing information in the live broadcast platform should be identified as advertising in essence.

The advertising process of medical devices should be compliant. The Interim Measures provide that advertisements for medical devices shall not be published without review, except for four circumstances: 1, the information provided by laws, regulations and rules that operators should provide to consumers is displayed; 2. Product samples and product packaging displayed only in physical form; 3, only advertise the product name; 4, only for use in professional exhibitions, internal meeting materials provided only to professionals, etc. It can be seen that, in addition to the above four cases, the medical device advertising process must be reviewed and then released, and shall not be published without review. The specific process for operators to handle medical device advertising review is as follows: 1. Prepare advertising review materials, including: Advertising Review Form, advertising sample consistent with the published content, business license, medical device product registration certificate or filing certificate, product labels and instructions registered or filed, production license documents, effective certification materials related to intellectual property rights involved in advertising, authorization documents, power of attorney; (2) Submit an application to the acceptance window of the advertising review authority where the operator is located, or submit an application by letter, fax, email or e-government platform; (3) Upon receipt of the application, the advertising review authority will make a decision on acceptance or rejection within five working days; 4. The advertising examination authority shall complete the examination within ten working days from the date of acceptance, and shall make a Decision on the approval of Advertising Examination for the advertisements that comply with the relevant laws and regulations. After the operator obtains the Decision on Approval of Advertisement Review, it may publish the approved advertisement contents within the validity period of the advertisement approval number.

The content of medical device advertising is the core part of compliance, which is the most concerned content of advertising review departments and law enforcement departments, and also the main cause of consumer complaints. The "Interim Measures" stipulate that medical device advertising: 1, should be true, legal, shall not contain false or misleading content, and the content of the advertisement should be approved by the drug regulatory department of the registration certificate or record certificate, registration or record of the product description content shall prevail; (2) Medical device advertisements involving the name, scope of application, mechanism of action or structure and composition of medical devices shall not exceed the scope of the registration certificate or filing certificate, registration or filing of the product description. Advertisements of medical devices recommended for personal use shall clearly indicate "Please read the product instructions carefully or purchase and use under the guidance of medical personnel"; 3, medical device product registration certificate has taboo content, precautions, advertising should be clearly marked "taboo content or precautions for details in the manual". At the same time, the "Interim Measures" also stipulates that the content of medical device advertising shall not contain the following circumstances: 1, the use or disguised use of the name or image of State organs, state organs, military units or military personnel, or the use of military equipment and facilities to engage in advertising; 2. Use the name or image of scientific research units, academic institutions, industry associations or experts, scholars, physicians, pharmacists, clinical dietitians, patients, etc., for recommendation and certification; (3) Contrary to the laws of science, express or imply that it can treat all diseases, adapt to all symptoms, adapt to all people, or necessary for normal life and treatment of diseases; (4) Cause the public to have unnecessary worries and fears about their health status and diseases, or make the public misunderstand that not using the product will cause certain diseases or aggravate the content of the disease; 5, containing "safe", "safe non-toxic side effects", "small toxic side effects"; Express or implied ingredients are "natural", and therefore safety is guaranteed; 6, containing "hot sale, rush, trial", "family essential, free treatment, free gift" and other inductive content, "evaluation, sorting, recommendation, designation, selection, award" and other comprehensive evaluation content, "invalid refund, insurance company insurance" and other assurance content, encourage consumers to use drugs, health food and special medical use formula food at will, excessive content; 7. It contains the name, address, contact information, diagnosis and treatment items, diagnosis and treatment methods of medical institutions, and the contents of medical services such as free diagnosis, medical consultation telephone, and special outpatient service; 8. Other contents prohibited by laws and administrative regulations.

In addition, the medical device advertisement should also comply with the relevant provisions of the Advertising Law, such as: 1, the advertisement indicates that the sale of goods or services accompanied by a gift, should express the variety, specification, quantity, period and manner of the accompanying gift of goods or services; 2, advertisements involving quoted data, statistics, abstracts, quotes and other citation content, should indicate the source, clearly state the scope of application and effective period. It cannot violate the prohibited content of the Advertising Law; (3) Where the advertisement involves a patented product or patented method, the patent number and patent type shall be indicated. Where no patent right has been obtained, it may not falsely claim in an advertisement that it has obtained a patent right; (4) Shall not disparage the goods or services of other producers or operators. At the same time, the advertisement of medical devices shall not contain the following contents: 1, the assertion or guarantee of efficacy and safety; 2. State the cure rate or effective rate; 3, compared with the efficacy and safety of other drugs, medical devices or other medical institutions; 4, the use of advertising spokespersons for recommendation and proof.

The form of medical device advertising should be compliant. The "Advertising Law" and the "Interim Measures" also have clear provisions on the form of medical device advertising: 1, the content that should be clearly marked in the medical device advertisement, its font and color must be clearly visible and easy to identify, and should be continuously displayed in the video advertisement; (2) Operators shall publish medical device advertisements in strict accordance with the content passed by the review, and shall not be edited, spliced or modified. For the content of the advertisement that has been examined and approved, if it needs to be changed, it needs to apply for the advertisement review again; 3, radio stations, television stations, newspapers, audio and video publishing units, Internet information service providers may not introduce health, health knowledge and other forms of disguised release of medical device advertisements; (4) Advertisements for medical devices shall not be published on mass media targeting minors.

If the operator publishes the medical device advertisement without review or the advertising content (except false advertisement) and the advertising form is illegal, it will be fined more than twice and less than three times the advertising cost. If the advertising cost cannot be calculated or is obviously low, it will be fined more than 100,000 yuan and less than 200,000 yuan. If the circumstances are serious, a fine of not less than three times but not more than five times the advertising expenses shall be imposed; if the advertising expenses cannot be calculated or are obviously low, a fine of not less than 200,000 yuan and not more than one million yuan shall be imposed. If the content of the advertisement for medical devices published is false, the market supervision and administration department shall order the advertisement to stop publication, order the advertiser to eliminate the impact within the corresponding scope, and impose a fine of not less than three times but not more than five times the advertising cost; if the advertising cost cannot be calculated or is obviously low, a fine of not less than 200,000 yuan and not more than one million yuan shall be imposed; If there are three or more illegal acts within two years or other serious circumstances, they shall be fined not less than five times but not more than ten times the amount of advertising expenses; if the amount of advertising expenses cannot be calculated or is obviously low, they shall be fined not less than one million yuan but not more than two million yuan, and their business license may be revoked, and the advertising examination authority shall revoke the documents of approval for advertising examination and shall not accept their application for advertising examination within one year.

To sum up, when publishing medical device advertisements, operators must meet the compliance of advertising process, advertising content and advertising form: that is, before advertising is published, apply to the local regulatory authorities for medical device advertising review, and then publish medical device advertisements after the review is passed; The contents of advertisements should be strictly examined and approved, especially the contents prohibited in the Advertising Law and the Interim Measures; The form of advertising should also comply with relevant regulations, especially not to edit, splice and modify the advertising content that has been reviewed. Only by meeting the above three compliance requirements can medical device advertising effectively avoid the risk of consumer complaints and administrative penalties.