Advertising of medical devices the examination and publication of standards
(April 28, 2009 National Administration for industry and commerce, Ministry of health, the State food and Drug Administration to 40th, published since May 20, 2009) first in order to ensure real, legitimate medical device advertising, science, developed this standard.
Article publish advertising of medical devices, shall comply with the People's Republic of China advertisement law (hereinafter referred to as the law on advertising), the People's Republic of China against unfair competition Act (hereinafter referred to as the anti-unfair competition law), the supervision and administration of medical devices Ordinance and relevant regulations of the State.
Article the following products should publish any advertisements:
(A) explicitly prohibit by law the food and drug regulatory agency production, sale and use of medical device products;
(B) the development of medical institutions in medical institutions in medical devices used internally.
Fourth medical advertisement in the product name, scope of application, performance, structure and composition, mechanism and other content should be based on products approved by the food and Drug Administration registration document shall prevail.
Article fifth medical device registration document there are taboos in contents, notes should be indicated in the advertisement "taboo or considerations as described in the manual."
Sixth medical equipment advertisement must be identified in approved medical device names, medical device manufacturer name, registration number, medical equipment approval number.
The approved medical device advertising on the radio when it is published, you can broadcast the medical equipment approval number.
Only medical device product name, not affected by the restriction in the preceding paragraph, shall identify the registration certificate of medical devices.
Seventh medical apparatus advertisements shall not be any non-medical device product name instead of the product name information.
Article eighth featured advertising of medical devices for personal use, to be marked with "Please read the product manual or purchased and used under the guidance of medical personnel."
Nineth medical devices advertised to improve and enhance sexual function, must be in approved medical device registration documents exactly the same scope may exhibit any sexual organs. Newspaper front pages, the magazine should publish any advertisements containing the content of the preceding paragraph.
Television stations, radio stations shall not 7:00-22:00 publish advertisements containing the content of the preceding paragraph.
Article tenth medical equipment in the scope and effectiveness of publicity should be scientifically accurate, must not occur in the following situations:
(A) contain assertions or assurances of efficacy;
(B) description of efficiency and cure rates;
(C) with other medical devices, drugs or other therapeutic methods comparison of efficacy and safety;
(D) to recommend personal use of medical device advertising, consumers lack medical equipment professional, technical knowledge and experience weakness, used outside the product registration documents of the specialized terminology or unscientific term that describes the product features or mechanisms;
(V) could not confirm its so-called scientific "research", "experiments or data" and other content;
(F) violation of law, express or implied, cure-all, all symptoms;
(VII) contains a "safe", "harmless", "invalid refund", "independent", "insurance" commitment terms, such as, "only", "exact", "latest technology", "the most advanced science", "national", "fill the gaps" absolute or exclusive terms;
(VIII) claim or imply that the medical device is a normal life or treat illnesses have to wait;
(I) containing express or implied that medical devices can cope with modern life or further studies and the required examination, can help improve or enhance performance, make energetic, competitive, higher educational and other content.
11th medical device advertisement should be publicized and guide rational use of medical devices, shall not, directly or indirectly, to encourage the public to buy used, shall contain the following contents.
(A) any unscientific statement or by rendering, exaggerated the harm caused by a health condition or disease, caused by public health or illness worries and fears, or misunderstandings of the public not to use the products will suffer from some kind of illness or worse;
(B) contain "family" or something similar;
(C) contain rating, rank, recommend, specify a comprehensive evaluation, selection, award and other content;
(D) contain the product is in "hot", "buy", "trial" and other content.
12th medical device advertisement shall not include the use of medical research institutes, academic institutions, medical organizations or experts, doctors, patient name and image as evidence of the contents. Advertising of medical devices shall not include the army unit or the names or images of military personnel.
May use military equipment, facilities, medical equipment advertising.
13th medical apparatus advertisements shall not contain public information, public events or other public interest content, such as information, economic and social development of all kinds of diseases or medical science technology.
14th medical advertisement must not contain the name of the medical institution, address, contact, medical projects, related to diagnosis and treatment, as well as free clinics, medical (hotline) opened special outpatient medical services, such as consulting, content.
15th medical apparatus advertisements shall not in minor publications and published on the channels, programs, program.
Not child-directed advertising of medical devices, shall not be introduced medical device, on behalf of the child. 16th according to the standard article sixth must appear in the advertising of medical devices the content of their fonts and colors must be clearly visible and easy to read.
Above content on TV, the Internet, displays and other media release, time shall not be less than 5 seconds.
17th in violation of the standards for publication of advertising, false or misleading advertising false advertising, according to the advertising law or relevant provisions of the unfair competition law will be punished.
Violation of this standard at its third, fourth, to publish the advertising of medical devices, punished in accordance with article 41st of the advertising Act.
Violation this standard other provides released advertising, advertising method, and anti-not due competition method has provides of, in accordance with advertising method punishment; advertising method, and anti-not due competition method no specific provides of, on has responsibility of advertising main, and advertising operators, and advertising released who, sentenced 10,000 yuan following fine; has illegal proceeds of, sentenced illegal proceeds three times times following but not over 30,000 yuan of fine. 18th article this standard as of May 20, 2009. March 3, 1995, issued by the SAIC advertising review of medical devices standards repealed at the same time.