No.: State Food and Drug Administration City [2005] No. 122
Timeliness: Currently in effect
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration):
In order to implement the State Council on the rectification and standardization of the market economic order of the deployment of the State Council to strengthen the In order to implement the State Council on the rectification and standardization of market economic order deployment, strengthen the review of medical device advertising, standardize the order of medical device advertising, to prevent illegal medical device advertisements jeopardize the health of the people, the State Food and Drug Administration has decided to establish a system of illegal medical device advertisement announcement. Now on the relevant requirements are notified as follows:
One, the establishment of illegal medical device advertisement announcement system, is the food and drug supervision and management department to perform the functions assigned by the State Council, with the relevant departments to regulate the order of medical device advertisement important measures, but also the practice of the "Three Represents" important thought, the implementation of the "people-oriented, governance", the "three represents" important thought, the "people-oriented, governance". "People-oriented, governance for the people" purpose, to ensure that the people use medical devices safe and effective specific embodiment. Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments should attach great importance to the establishment of illegal medical device advertising announcement system of significance, to overcome the fear of difficulties, and actively deployed, in accordance with the requirements of this work well.
Second, the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) to establish and improve the medical device advertising monitoring team and work system, to do a good job in the jurisdiction of the release of the daily monitoring of medical device advertising. For the illegal release of medical device advertisements, to regularly publish "illegal medical device advertisement bulletin". At the same time, before the 15th of each month, the illegal medical device advertisements found in the jurisdiction shall be reported to the Office of Advertising Review and Supervision of the State Food and Drug Administration (Address: China National Institute for the Control of Pharmaceutical and Biological Products, No.2, Tiantan Xili, Chongwen District, Beijing, P.R.C. 100050. or send an e-mail; baiyuping@nicpbp.org.cn). The State Food and Drug Administration for summary review, every two months regularly issued "illegal medical device advertising bulletin summary".
The illegal medical device advertisements reported to the State Food and Drug Administration include: unauthorized release of medical device advertisements without approval; tampering with the approval of the content of the medical device advertisements released; prohibited release of medical device advertisements. Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) in accordance with the development of illegal medical device advertising statistics table (Annex 1) to fill out, check the seal of the Bureau, in writing or through the review of medical device advertisements on the network. Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) should be required to actively carry out the monitoring of illegal medical device advertisements and report illegal medical device advertisements. The State Food and Drug Administration will in due course on the establishment of illegal medical device advertisements in various regions of the announcement system for inspection.
Attachment: 1. Statistical Table of Illegal Medical Device Advertisements
2. Requirements for Filling in the Statistical Table of Illegal Medical Device Advertisements
State Food and Drug Administration
April 1, 2005
Attachment 1:
Statistical Table of Illegal Medical Device Advertisements
Fill in the unit: Fill in the time: Year Month Day Results ┃ ＞＞＞＞＞＞───────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼───────┼────┼────┼────┼────┼────┼────┼────┼────┼────┼──── ─┼────┼───┼───┼──┼──┼──┼──┼──┨┃10 │ │ │ │ │ │ │ │ │ │ ┃┗━━┷━━┷━━━━━━━┷━━━━┷━━━┷━━━┷━━┷━━┷━━┷━━┷━━┛
填表人：
附件2：
违法医疗器械广告统计表填写 Requirements
1. "Product name" should be accurately filled in the name of the product (should be approved by the certificate of registration of the product name shall prevail), there is a trademark publicity should be in the trademark after the addition of "brand", shall not fill in the trademark only; there are products with trade names should be the same time Mark the common name of the product; such as the name of the advertisement and the actual name of the approved product does not match, in addition to fill in the correct product name, you can fill in the name of the product after the product name in the advertisement of the product name: ***; if you can't confirm the real name of the product, you can fill in the "product name" column in the advertisement of the product name. Product name.
2. "The name of the advertiser indicated in the advertisement" refers to the name of the advertiser indicated in the medical device advertisement published in the media, such as: medical device manufacturers, operating companies, medical institutions, etc., can not be confirmed, you can fill in the "Not indicated ".
3. "Product manufacturer's name" refers to the medical device advertisements in the medical device manufacturer, such as advertising content is not indicated, the food and drug supervision and management department should make every effort to find out the name of the medical device manufacturer, for really can not be confirmed, you can fill in the "not marked ", but should be promptly transferred to the same level of industrial and commercial administrative departments for investigation.
4. "Advertising approval number" refers to the medical device advertising approval number indicated in the advertisement.
5. "Publication media name" means the name of the media in which the medical device advertisement is actually published.
6. "Publication time" refers to the actual publication time of the medical device advertisement in the publication medium, the same advertisement, if only the publication time is different, all the dates should be combined in the same file.
7. "Reasons for violation" includes the following:
(1) "unauthorized alteration of the approval content" means that the medical device advertisements were published with the approval number of the medical device advertisements are true, but unauthorized alteration of the approval content was made at the time of publication. The behavior of unauthorized alteration of the approval content. Fill in the reasons for this violation, and at the same time should fill in the "advertising approval number" under the approval number of the medical device advertisement.
(2) "unauthorized release without approval" means that the medical device advertisement was released without obtaining a valid advertising approval number. "The use of expired advertising approval number" and "forgery, fraudulent advertising approval number" are "unauthorized publication without approval" of the illegal behavior.
(3) "prohibited advertising" refers to the medical device products in any media shall not be published in any form of advertising behavior. For example, the provisions of the trial production stage of medical devices shall not be published medical device advertising.
8. "Results" should be filled in the transfer to the same level of industrial and commercial administration.
9. "Processing department" refers to the medical device advertisements to deal with food and drug supervision and management departments at or above the county level.
10. "Publication" refers to the number of times the medical device advertisement is published in the media, the number of times should correspond to the content of the publication time.
Remarks:
This regulation came into effect on April 01, 2005, and will remain in force until 2022
Last update: 2021.01.21