Interpretation of "Medical Device Advertising Review Dissemination Standard"
From：jianghao Time：2010-8-13 11:15:00
State Administration for Industry, Ministry of Health, State Food and Drug Administration recently issued a "review of published medical device advertising standards", since May 20, 2009 shall come into force. Understanding of this document will help the public effectively identify the illegal advertisement of medical devices to guard against false propaganda "to deceive" people.
Nine categories of cases seen by the public to guard against scientific
According to "review of published medical device advertising standards", medical advertisements such as the scope and effectiveness of publicity should be scientific and accurate, not the following nine categories of cases:
1. With that assertion or guarantee effectiveness;
2. Illustrate the efficiency and the cure rate;
3. And other medical devices, drugs or other treatments compared the efficacy and safety;
4. Individuals recommended to the advertising of medical devices, medical devices using consumer Quefa professional, technical knowledge and experience of vulnerability, using Chaochu product registration documents other than the specialized terminology or scientific terms to describe the characteristics of the product or Mechanism;
5. Contains not confirm the so-called scientific "findings," "experiment or data to prove" and other aspects;
6. Violation of scientific laws, expressed or implied cure, to adapt to all the symptoms;
7. With "security", "non-toxic side effects," "invalid refund," "no reliance", "insurance companies" and other commitments of terms, with "only", "exact", "latest technology" "the most advanced science," "National products "," fill the gaps "and other absolute or exclusive terms;
8. Claim or imply that the medical device or treatment for the disease to normal life and other elements necessary;
9. Contains express or implied, of the medical device can cope with modern stress of life or further studies, the examination of need, can help improve or enhance performance, make energetic, enhance competitiveness, to increase, to puzzle and so on.
Equipment should be encouraged to use reasonable consumption is prohibited
Advertisements of medical devices should promote and guide the rational use of medical devices, shall not directly or indirectly encourage the public to buy used. To do this, "Review of published medical device advertising standards" to provide, medical advertisements shall not contain the following:
1. Unscientific statements or by rendering, exaggerating a medical condition caused by damage or disease, in which the public health caused by illness or caused worry and fear, or to mislead the public not to use the product will suffer from some kind of disease or aggravate the disease;
2. "Families must have" or similar content;
3. Rating, ranking, recommend, specify, use, award-winning, comprehensive evaluation of content;
4. Formulation of the product is "hot," "buy," "trial" and other content.
Scope of stress release for minors may not
In order to protect the legitimate rights and interests of minors, "Review of Medical Devices Advertising Dissemination Standard" provides no medical equipment advertising publications and channels in the minors, programs, part on the release; not a child-appealing, not the child's name introduction of medical devices.
In addition, advertisements relating to medical devices to improve and enhance sexual functional content, and must be approved medical 器械 proof of registration document for the same affected area, Bude Chuxianbiaoxian sex organs of the content.
Front page of newspapers and periodicals shall not publish the cover containing such content advertising, television and radio stations are not published in the 7:00 to 22:00 with such content ads.
Four elements should be available to indicate the specific content
According to "review the published standards for medical device ads," advertisements in medical devices must be marked four elements: the name of approved medical devices, medical device manufacturer name, medical devices and medical equipment registration No advertising of approval. Only the approval of medical devices released in radio advertising, you can not broadcast advertising of approval.
Advertisements of medical devices in medical institutions must not contain the name, address, contact, medical consultations, treatments, and the free clinic, health care (Hotline) consulting, set up special clinics and other medical services, content.
In addition, the medical device product registration documents have taboo content, pay attention to the matter, should be indicated in the ad "taboo content or see note instructions."
Recommended for personal use of the medical device product advertising, must also be marked "Please carefully read the instructions or under the guidance of medical personnel in the purchase and use."