Medical device advertising review and release standards

Article I In order to ensure the truthfulness, legality and science of medical device advertisements, this standard is formulated. Article 2 The release of medical device advertisements shall comply with the "Chinese People's *** and State Advertising Law" (hereinafter referred to as the "Advertising Law"), "Chinese People's *** and State Anti-Unfair Competition Law" (hereinafter referred to as the "Anti-Unfair Competition Law"), "Regulations on the Supervision and Administration of Medical Devices" and the relevant state regulations. Article 3 The following products shall not be advertised:

(1) medical device products whose production, sale and use are expressly prohibited by the Food and Drug Administration in accordance with the law;

(2) medical devices developed by medical institutions for internal use within medical institutions. Article IV medical device advertisements about the product name, scope of application, performance structure and composition, mechanism of action and other content should be approved by the food and drug supervision and management department of the product registration documents shall prevail. Article V medical device product registration documents have contraindicated content, precautions, should be marked in the advertisement "contraindicated content or precautions see instructions". Article VI of the medical device advertising must be marked with the name of the approved medical device, medical device manufacturer name, medical device registration number, medical device advertising approval number.

Approved medical device advertisements in the radio station can not broadcast medical device advertising approval number.

Only the name of the medical device product appears, not subject to the preceding paragraph, but should indicate the medical device registration number. Article VII medical device advertising shall not be any non-medical device product name instead of the medical device product name for publicity. Article 8 The advertisements of medical devices recommended for personal use must indicate "please read the product manual carefully or purchase and use under the guidance of medical personnel". Article IX medical device advertisements involving the improvement and enhancement of sexual function, must be completely consistent with the approved medical device registration documents in the scope of application, shall not appear to show the content of the sexual organs.

The front page of newspapers and the covers of periodicals shall not publish advertisements containing the contents of the preceding paragraph. Television and radio stations shall not publish advertisements containing the contents of the preceding paragraph from 7:00 to 22:00. Article 10 The publicity on the scope of application and efficacy of medical device advertisements shall be scientific and accurate, and the following shall not be allowed:

(1) Containing assertions or guarantees indicating efficacy;

(2) Stating the effective rate and the cure rate;

(3) Comparing the efficacy and safety with that of other medical device products, medicines, or other therapeutic methods;

(E) contains the so-called "research findings", "experiments or data to prove" and other aspects;

(F) violates the laws of science, expressly or impliedly cures all diseases and adapts to all the symptoms;

(G) contains the word "safe", "no toxic side effects", "invalid refund", "no dependence", "insurance companies" and other promising terms, containing "the only one", "the only one", "the only one", "the only one", "the only one", "the only one", "the only one", "the only one". The terms "unique", "precise", "the latest technology", "the most advanced science", "state-of-the-art product", "national product", "the latest technology", "the latest technology", "the most advanced science", "the latest technology", "the most advanced science", "national products", "fill the gaps in the country" and other absolutist or exclusive terms;

(h) claiming or implying that the medical device is necessary for normal life or treatment of disease and other content;

(i) contains express or implied that the medical device can cope with modern stressful conditions. Implying that the medical device can cope with the needs of modern stressful life or schooling, exams, can help improve or enhance performance, can make the energy, enhance competitiveness, can increase height, can be beneficial and so on. Article 11 The advertisement of medical devices shall publicize and guide the rational use of medical devices, shall not directly or indirectly encourage the public to buy and use, and shall not contain the following contents.

(a) contains unscientific expressions or by rendering, exaggerating the harm caused by a certain health condition or disease, cause the public to worry and fear of the health condition or disease, or make the public misunderstand that not to use the product will suffer from a certain disease or aggravation of the condition;

(b) contains "essential for the family "or similar content;

(C) contains evaluation, ranking, recommendation, designation, selection, awards and other comprehensive evaluation content;

(D) contains the expression that the product is in the "hot", "rush to purchase "," trial "and other content. Article XII of the medical device advertisements shall not contain the use of medical research units, academic institutions, medical institutions or experts, doctors, patients, the name and image of the proof of the content.

Medical device advertisements shall not contain the name and image of military units or military personnel. Shall not use military equipment, facilities for medical device advertising. Article XIII of medical device advertising shall not contain information involving public ****, public **** events or other public **** interests associated with the content, such as various types of disease information, economic and social development results or scientific and technological achievements other than medical science. Article 14 The advertisements of medical devices shall not contain the name, address, contact method, diagnosis and treatment items, diagnosis and treatment methods, as well as the content of medical services such as voluntary medical consultation, medical (hotline) consultation, and the opening of special outpatient clinics. Article XV of medical device advertisements shall not be released in the minor publications and channels, programs, columns.

Medical device advertisements shall not take children as the object of appeal, and shall not introduce medical devices in the name of children.