china law
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Standards on the Examination and Approval of Medical Appliance Advertisement - 1995

(Promulgated by the State Administration for Industry and Commerce on March 3 and effective on the same day)

 

These Standards are formulated with a view to ensuring the authenticity, lawfulness and scientific contents of the medical appliances advertisements.

Article 1
Publication of medical appliance advertisements should abide by the Advertising Law of the People's Republic of China and the relevant State regulations on medical equipment management, and should also comply with the procedure detailed in the Measures on Examination and Approval of Medical Appliance Advertisements.

Article 2
Advertisements of the following medical appliances are prohibited:

(1) Medical appliances which enter the market without approval by the State Pharmaceutical Administration, or local pharmaceutical management departments of provinces, autonomous regions and centrally-governed municipalities (or pharmaceutical administrative departments at same level);

(2) Medical appliances which were produced overseas and brought into the Chinese market without the approval of the government of the producing countries (or regions);

(3) Medical appliances produced by non-licensed medical producers;

(4) Medical appliances which are still in the trial production or trial clinical stage;

(5) Medical appliances which are claimed to be effective in treating Aids or in treating and improving sexual dysfunctions.

Article 3
The advertisements of medical appliances shall conform with the appliance's printed specifications as approved by the relative authorities. Their advertisements shall not exceed the contents as indicated in their printed specifications.

Article 4
Medical appliance advertisements shall not contain unscientific assertions or promises relating to drugs' efficiency, such as having top efficacy", ensuring complete cure" etc..

Medical appliance advertisements shall not depreciate other similar products, and shall not contain comparison between itself and other equipment in terms of efficacy and safety.

Article 5
Medical appliance advertisements shall not contain absolute descriptions or expressions, such as the highest technology", the most advanced scientific achievement" etc..

Article 6
Medical appliance advertisements shall not contain information on the curing rate or efficiency rate of the equipment, nor on any awards won by the equipment.

Article 7
Medical appliance advertisements shall not use the quotes, appearances or countenances of medical research bodies, scientific institutions, clinical organizations, experts, doctors or patients as supporting evidence.

Article 8
Medical appliance advertisements shall not describe the symptoms and pathology of a disease in such a way as to suggest to non-patients that they may have also been affected, nor should they imply that a disease will worsen if the advertised appliance is not used.

Article 9
Medical appliance advertisements shall not contain pledges such as buyer will be refunded if it proved ineffective," insured by insurance companies," etc..

Article 10
Medical appliance advertisements shall not take advantage of consumers' lack of relevant knowledge and experience, and mislead such consumers with professional idioms or illustrations that could not able be verified.

Article 11
When recommending medical appliances to individuals, the remark of to be used under instruction of doctors" shall be written into the advertisements.

Article 12
The registered number of the examination and approval certificate for the medical appliance advertisement shall be clearly indicated in the advertisement.

Article 13
Advertising dealers shall not design and make medical appliances advertisements that violate these Standards, and the media shall not publish such advertisements.