Medical instrument advertisement examination method

Article 1 in order to strengthen the management of medical equipment, medical equipment advertisement advertisement and authenticity of the legitimacy, according to the PRC, advertising law (hereinafter referred to as the "advertisement law) and the PRC anti-unfair competition law, the supervision and administration of medical devices and the relevant state regulations, medical advertising supervision and management, the provisions are formulated.
Article 2 through certain media and forms of advertising contain medical instrument issued by name and product scope, composition, structure and properties of the content such as mechanism, shall, in accordance with these measures.
Only the name of medical products publicity advertisement examination, but without should be labeled in medical equipment registration number.
Article 3 the medical examination for advertising, accord with following laws and regulations and the relevant provisions, shall be approved before:
(a) "advertisement law",
(2) the medical equipment supervision and management regulations,
(3) issued by the medical device advertisement examination standard,
(4) the other state administration of advertising regulations.
Article 4 provinces, autonomous regions, municipalities directly under the pharmaceutical supervisory and administrative department is a medical instrument advertisement examination organizations within their respective administrative areas, responsible for medical devices advertisement examination work.
The administrative department for industry and commerce above the county level are medical advertising regulatory authority.
Article 5 the state food and drug supervision and administration of medical devices advertisement examination organizations of medical devices advertisement examination work for guidance and supervision of medical devices, advertisement examination organizations in violation hereof, shall be dealt with according to law.
Article 6 the medical instrument advertising approval must be legally qualified applicants of medical device manufacturing enterprise or medical equipment management enterprise. Medical equipment management enterprise as applicant must obtain, medical device manufacturing enterprise.
The applicant may entrust a agent for medical advertising approval application matters. Do STH for sb person should be familiar with the relevant state administration of advertising regulations and related laws and regulations.
Article 7 for medical devices, it shall submit the approval document number of ads medical device manufacturing enterprise locus of medical devices advertisement examination organizations.
Apply for import medical advertising, it shall submit the approval of registration forms of medical devices list of medical equipment agent of advertisement examination organizations, If this product overseas medical device manufacturing enterprise in China with the organization, to the organization of medical instrument advertisement examination organizations.

Article 8 for medical devices shall fill in the approval document number of advertising, the advertisement examination table of medical devices, issued the content and consistent sample (sample, demo) and medical equipment, electronic documents submitted to advertising the true, lawful and valid proof file:
(a) the copy of the business license,
(2) the applicant of the medical device manufacturing enterprise licence "or" medical equipment management enterprise licence "copy,
(3) the applicant's medical equipment management enterprise shall submit medical device manufacturing enterprise agreed to its original documents as applicant,
(4) do STH for sb the person to bid for the medical advertising, it shall submit the approval document number of the original letter of proxy and do STH for sb person the photocopy of the business license subject qualification certificate, etc.
(5) product registration certificate for a medical device (including the medical equipment, medical apparatus registration certificate of registration forms of photocopy; etc.)
(6) for import medical advertising approval, shall provide the medical apparatus registration form "the agent or foreign medical device manufacturing enterprise established in the organization's subject qualification certificate photocopy,
Advertising (7) involved in medical equipment registered trademarks, patents, authentication and so on contents shall submit relevant documents of proof copies of effective advertisements and other documents of proof content authenticity.
Provide the provisions of the copy of certificate, certificate holder signature.
Article 9 has one of following state, medical equipment advertisement examination organizations shall not accept this enterprise the varieties of medical devices for advertising:
(a) belong to 17, 19 and 20 regulations don't accept the case,
(2) revoked medical advertising approval of the administrative procedure is executed.
Article 10 medical instrument advertisement examination organizations received medical advertising, approval of the application materials are complete and comply with statutory requirements of medical devices, issued a notification of acceptance of advertising, Application materials are incomplete or not, shall comply with statutory requirements on the spot or within 5 working days inform the applicant a supplement to the full content, Fails to inform, since the date of receiving the application materials to accept.
Article 11 medical instrument advertisement examination organizations shall be the date of acceptance within 20 working days, in accordance with the contents of advertisements for examination. To examine qualified medical equipment, medical equipment advertisement advertisement approval, To review the unqualified medical devices shall be issued to advertisement advertisement approval of medical devices, notify the applicant decision and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative litigation rights.
To approve of medical equipment, medical equipment advertisement advertisement examination organizations shall be submitted to the state food and drug administration. The state food and drug administration to record the problems of medical equipment, medical devices shall be obliged advertisement advertisement examination organizations shall be rectified.
To approve of medical devices advertising, pharmaceutical supervisory and administrative departments shall, through the government website to be published.
Article 12 medical advertising approval is valid for 1 year.
Article 13 the medical ads approved in release may change the contents of advertisements. Medical devices to alter the contents of advertisements shall apply for afresh medical advertising approval.
Article 14 the medical devices to release advertisement advertisement, medical devices shall be the medical instrument advertisement examination table "original save 2 years for future reference.
The advertisement publishers, advertising operators are advertising agency, the release of medical devices shall examine the advertisement, the medical instrument advertisement examination table of examination and approval in accordance with the original, and the content of the medical device advertisement examination table for 2 years keep a photocopy.
Article 15 the medical equipment has been approved by the advertising, have one of following state, the original approval of medical devices advertisement examination organizations for review. During the review, the medical instrument advertising can continue to release:
(a) the state food and drug administration that medical instrument advertisement examination organizations approved medical instrument is not in conformity with the provisions of the contents of advertisements,
(2) advertising regulatory authorities at or above the provincial level review suggest,
(3) medical devices that advertisement examination organizations shall review the other case.
After reexamination, think medical instrument advertising does not conform to the legal conditions, medical equipment advertisement examination organizations should be corrected, take the medical instrument, the advertisement examination table of medical instrument advertising approval.
Article 16 has one of following state, medical equipment advertisement examination organizations shall cancel the medical advertising approval:
(a) medical advertising applicant the medical device manufacturing enterprise licence ", "business license of medical devices is revoked,
(2) of the product registration certificate for a medical device is revoked, revoke, cancellation,
(3) by the pharmaceutical supervisory and administrative departments shall terminate the manufacture, sale and use of medical devices,
(4) and other laws and regulations shall be revoked of administrative licensing.
Article 17 tamper with the approved medical advertising false conduct propaganda, the pharmaceutical supervisory and administrative department shall order it to stop the medical instrument, the advertising business of this type of medical devices, advertising approval within 1 don't accept this enterprise the advertisement examination application.
Article 18 the recommended medical advertising contain any applicable scope expanding medical devices, medical devices such as exaggerated effect and mislead consumers, the pharmaceutical supervisory and administrative department at or above the provincial level shall, upon discovery compulsory administrative measures taken in illegal advertisement, the enterprise to eliminate the bad influence, pause before medical products within their jurisdiction in the sales.
Illegal advertisement enterprise if application, must remove compulsory administrative measures in the corresponding media release, and continuous correction shall not be less than 3 days to publish to sow, And to make compulsory administrative measures decided to provide the pharmaceutical supervisory and administrative departments of the following:
(a) issued the original media apocalypse correction or CD,
(2) illegal advertisement enterprise issued by the rectification of the medical report,
(3) compulsory administrative measures.
The decision made compulsory administrative measures by the pharmaceutical supervisory and administrative departments in received illegal issued medical advertising enterprises, after the materials submitted within 15 working days made whether to terminate the compulsory administrative measures.
Article 19 to provide false materials for medical equipment, medical equipment and advertisement advertisement examination organizations that don't accept this year, one of the enterprises and advertising.
Article 20 to provide false materials for medical equipment, medical equipment and advertisement advertisement approval, medical equipment advertisement examination organizations shall be revoked after found in medical devices, and advertising approval within 3 years don't accept this enterprise the advertisement examination application.
Article 15 and article 16 according to these measures, 17, the article, cancellation or withdraw the approval document number of advertisements of medical devices, medical devices must stop immediately release advertisement.
Medical instrument advertisement examination organizations in accordance with these measures 15 and 16 and 17, the article back, cancellation or revoke the approval document number of advertisements of medical devices shall promptly report of the state food and drug administration, administrative decision making in five working days from the date of the notice within the advertising regulatory authority. This advertisement to release, the advertising supervision and administrative organizations shall be dealt with according to law.
Article 22 pharmaceutical supervisory and administrative departments of examination and approval shall be issued by the medical advertising monitor checks. The medical equipment for illegal issued by the pharmaceutical supervisory and administrative departments of advertising, fill in the illegal advertisements of medical devices, along with illegal deportation notices of medical devices as sample, advertisement to the advertising regulatory authority in the investigation.
Belong to different approved by tamper with the medical devices to the contents of advertisements, medical equipment advertisement examination organizations shall also to the original examination and approval of the medical instrument advertisement examination authority in accordance with these measures, 17 of the cancellation of the approval document number of medical instrument advertising suggestion.
Article 23 the release of illegal advertisements of medical devices if the circumstances are serious, the provinces, autonomous regions, and municipalities directly under the pharmaceutical supervisory and administrative departments shall regularly publish, and report to the state food and drug administration, by the state food and drug administration released summary.
For releasing false advertisements of medical devices is serious, when necessary, by the state administration for industry and commerce and the state food and drug administration joint announcement.
Article 24 without approval issued by the medical advertising and medical devices with the examination and approval of the content of the advertisement, the advertising supervision and management organizations shall be based on the advertisement law article 43 stipulation punished, Constitute the false advertisement or false advertising, the advertising supervision and management organizations shall, in accordance with the advertisement law of the People's Republic of China or the relevant anti-unfair competition law shall be punished.
Article 25 the advertising regulatory authority illegal advertisements of medical devices, involving medical professional and technical content need, shall notify the content that will be needed by the pharmaceutical supervisory and administrative department at or above the provincial level, the pharmaceutical supervisory and administrative department at or above the provincial level shall, after receiving the notification of 10 days will be recognized results feedback advertising regulatory authority.
Article 26 medical instrument advertisement examination personnel and advertising supervision and management personnel shall accept the advertising law, the supervision and administration of medical devices regulations and other relevant laws and regulations of the training. Medical instrument advertisement examination organizations and the advertising regulatory authority personnel neglects his duty, abuses his power or engage in malpractices for personal gain, shall be given administrative sanctions in accordance with the relevant provisions, Constitutes a crime, shall be investigated for criminal responsibility according to law.
Article 27 advertising approval for medical devices YiXie wide X (visual) first trial 0000000000 number ", "YiXie wide X (sound) first trial 0000000000 number", "X YiXie wide 0000000000 first trial ()". "X" for all provinces, autonomous regions, and municipalities directly under the central government shall referred to, "0" by 10 digits, six years after the examination, represent four representative ads approved serial number. "" "" "" representative for advertising media forms of classification code.
Article 28 these measures on May 20, 2009. In 1995, March 8 issued by the medical instrument advertisement examination method "(the state administration for industry and commerce, the state administration for medicine makes the first 24) shall be repealed simultaneously.