Advertising Of Medical Devices Review

Original Language Title: 医疗器械广告审查办法

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/200907/20090700137314.shtml

Advertising of medical devices review (April 7, 2009 Ministry of health, and national business administration General, and national food drug supervision authority makes 65th, announced since May 20, 2009 up purposes) first article for strengthening medical devices advertising management, guarantee medical devices advertising of authenticity and legitimacy, according to People's Republic of China advertising method (following referred to advertising method), and People's Republic of China anti-not due competition method, and medical devices supervision Management Ordinance and national about advertising, and medical devices supervision management of provides,

    These measures are formulated.

    Article by certain media and publish the advertising contains medical device names, product scope, structure and composition, mechanism of performance, in accordance with this approach should be reviewed.

    Only the advertising of medical devices product name without review, but when information should be noted, registration certificate of medical devices.

    Advertising of medical devices application review article, in line with the relevant provisions of the following laws and regulations and, before they can be passed to review:

    (A) the law on advertising;

    (B) of the regulation on supervision and administration of medical devices;

    (C) the advertising of medical devices the examination and publication of standards;

    (D) advertising management of other provisions of the State.

    Fourth of provinces, autonomous regions and municipalities directly under the supervision and management departments are advertising review bodies medical devices, is responsible for the advertising of medical devices the review work within their respective administrative areas.

    Industry and commerce administration departments at or above the county level is the supervision and administration of medical device advertising agency.

    Fifth the State food and Drug Administration on the advertising of medical devices medical device advertising review bodies review guidance and supervision, on the advertising of medical devices review of the conduct of organs in violation of these regulations, be dealt with according to law. Article sixth medical equipment approval number applicants must have legal qualifications of a medical device manufacturer or medical device business.

    Medical device distributing enterprise as the applicant must obtain the medical device manufacturer's consent. Applicant may appoint agent agent bid of medical equipment approval number.

    Management agent should be familiar with the national advertising laws, rules and regulations.

    Article seventh medical equipment approval number shall be made to the medical device manufacturer located advertising review bodies.

    Apply for importing medical equipment approval number shall be made to the registration of medical device registration form set out in the medical devices, where the agent advertising review bodies; if the product is outside of medical device manufacturing companies have organizations in the territory, the seat of the organization is to advertising review bodies medical devices.

    Article eighth of medical equipment approval number, should fill out the medical device advertising review form, and attach a sample that is consistent with the published content (demos, sample) and advertising of medical devices electronic documents, real, legitimate and effective together with the following supporting documents:

    (A) the copy of the business license of the applicant;

    (B) the applicant's medical device manufacturing enterprise license or copy of the medical device distributing Enterprise license;

    (C) the applicant's medical device business, should be submitted to medical device manufacturers agreed to it as proof of applicant's original;

    (D) the agent on behalf of the bid of medical equipment approval number, should be submitted to the applicant's original power of Attorney and agent license, qualification certificate;

    (E) product registration certificate of medical devices (medical device registration certificate, the registration of medical device registration form, etc) copy;

    (F) applying for import of medical equipment approval number, should be explicitly stated in the medical device registration form provided agents or foreign medical device manufacturing enterprises established within the Organization of the qualification certificate copy;

    (G) advertisements relating to medical devices to register trademarks, patents, certification, and shall submit the relevant proof copy of the document and other documents that confirm the advertising content authenticity.

    Copies of the supporting documents provided for in this article, the holder of the document you want signature confirmation.

    Nineth under any of the following circumstances, inadmissible advertising review bodies medical devices to the enterprise the advertising of medical devices the application:

    (A) of this article 17th, 19th, 20th case of inadmissibility provided for in article;

    (B) the withdrawal of medical equipment approval number of administrative procedure is being performed.

    Tenth Article medical devices advertising review organ received medical devices advertising approved paper, application Hou, on application material complete and meet statutory requirements of, to medical devices advertising accepted notice; application material not complete or not meet statutory requirements of, should spot or in 5 a days within once told applicants need correction of all content; late not told of, since received application material of day up that for accepted. 11th medical device advertisement examination authority shall, within 20 working days from the date of acceptance, according to law to review advertising content.

    On examination of medical device advertising, sent medical equipment approval number; not qualified to review medical device advertising shall not be issued to medical equipment approval number of the decision, notify the applicant in writing and state the reasons, at the same time inform the applicant have the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law. On approval of medical device advertising, advertising review bodies medical devices should be reported to the State food and Drug Administration for record.

    State food and Drug Administration for record-keeping problems in advertising of medical devices, shall instruct the advertising of medical devices the review authority to remedy the situation.

    To approve advertising of medical devices, pharmaceuticals supervision and management departments should be available to the community through Government websites.

    12th medical equipment approval number is valid for 1 year. 13th approved medical device advertisement, publication shall not change the ad content.

    Advertising of medical devices needed changes, you should reapply for medical equipment approval number.

    14th advertising of medical devices the applicant self publish advertising of medical devices, medical device advertisement examination form for the original should be saved for 2 years for reference.

    Advertisers, advertising agents advertising the applicant Agency, publishing, advertising of medical devices, shall examine the medical device advertisement examination form for original, in accordance with the review and approval of the content, and save the copy of the medical device advertisement examination form for 2 years for reference. 15th already approved medical device advertisement, any of the following circumstances, the original approval of medical device advertising review bodies review.

    During the review, the advertising of medical devices can continue to release:

    (A) the State food and Drug Administration medical device advertising review agencies advertising does not comply with the provisions;

    (B) the review of recommendations of the advertising supervision and administration authorities at or above the provincial level;

    (C) medical device advertising review bodies deem a review of other cases.

    After review, think of advertising does not meet the statutory requirements for medical devices, medical device advertising review bodies should be corrected, and recovery of the medical device advertising review form, the medical equipment approval number is invalid.

    16th under any of the following circumstances, the medical device advertising review bodies medical equipment approval number shall be revoked:

    (A) the advertising of medical devices medical device manufacturing enterprise license of the applicant and the medical device distributing Enterprise license revoked;

    (B) medical device certificate revocation, revocation, cancellation of registration;

    (C) the pharmaceutical supervisory and administrative departments shall order the termination of production, sale and use of medical devices;

    (D) the provisions of other laws or regulations of administrative license shall be revoked.

    Article 17th tampered with approved advertising content for any false advertising of medical devices, by the pharmaceutical supervisory and administrative departments shall be ordered to immediately stop the release of medical device advertising, revoke the enterprise medical equipment approval number of the varieties, not accepted within 1 year of the enterprise the vetting of advertising.

    18th to recommend personal use of medical device advertisement contains any extended application range, absolute exaggerate the efficacy of medical devices such as cheating and misleading content, pharmaceutical supervisory and administrative departments at or above the provincial level found, compulsory administrative measures shall be taken, in front of the enterprises that illegally advertising the Elimination of adverse effects, suspended sales of the products in the area of medical devices.

    Illegal advertising companies applied for lifting of compulsory administrative measures, must publish corrections on the appropriate media revelations, and published not less than 3 days in a row and to make decision of compulsory administrative measures of pharmaceutical supervisory and administrative departments provide the following materials:

    (A) publish the correct lessons from the original media or discs;

    (B) modification of the enterprises that illegally publish advertising of medical devices report;

    (C) the application of compulsory administrative measures.

    Make a decision of administrative coercive measures received illegal drug regulatory authorities publish material submitted by the advertising of medical devices, within 15 working days to make a decision on whether to lift the compulsory administrative measures.

    19th to provide false information to apply for advertising approval of medical devices, found by the advertising review bodies medical devices, will not be accepted within 1 year of the enterprise the vetting of advertising.

    20th to provide false information to apply for advertising approval of medical devices, medical equipment approval number of medical device advertising review bodies should be withdrawn after it was discovered that medical equipment approval number, and will not be accepted within 3 years the enterprise the vetting of advertising.

    Article 21st in accordance with this article 15th, 16th, 17th, 20th, recovery, cancellation or revocation of medical equipment medical equipment approval number must immediately stop publishing. Medical device advertising review bodies in accordance with article 15th, 16th, 17th, 20th, resumption, cancellation or revocation of medical equipment approval number, shall report to the State food and drug administration, and make a decision of administrative handling within 5 working days of the date notice advertising regulatory bodies at the same level.
The ads continue to be published, supervisory and administrative organs shall be dealt with by advertising.

    22nd pharmaceutical supervisory and administrative departments shall monitor the examination and approval of medical device advertising check.

    To publish illegal advertising of medical devices, pharmaceuticals supervision and management departments to fill out the notification of transfer of illegal advertising of medical devices, along with the illegal advertising of medical devices, such as samples, transferred to the peer advertisement supervision and management organs investigated and dealt with.

    Is remote upload tampering with approved medical device advertising content, publishing medical device advertising review bodies should be submitted to the original examination and approval of medical device advertising review bodies in accordance with article 17th of this approach the proposed removal of medical equipment approval number.

    Released 23rd article on illegal advertising of medical devices the circumstances are serious, drug regulatory agency of provinces, autonomous regions and municipalities should publish on a regular basis, and report to the State food and drug administration, summary published by the State food and drug administration.

    Publication of false advertising of medical devices the circumstances are serious, if necessary, by the State administration for industry and commerce in conjunction with the State food and drug administration, the joint shall be published.

    24th article without review approved released of medical devices advertising and released of medical devices advertising and review approved of content not consistent of, advertising supervision management organ should according to advertising method 43rd article provides be punishment; constitute false advertising or inductive misunderstanding of false publicity of, advertising supervision management organ should in accordance with advertising method or People's Republic of China anti-not due competition method about provides be punishment.

    25th ad regulatory agencies investigate and deal with cases of illegal advertising of medical devices, involving medical devices professional content needs identified, shall inform of the need to identify the pharmaceutical supervisory and administrative departments at or above the provincial level, pharmaceutical supervisory and administrative departments at or above the provincial level shall, within 10 working days after receiving the notice of determination results advertising supervision and administration authorities. 26th medical device advertising review staff and advertising regulatory staff shall be subject to the advertising law, the supervision and administration of medical devices Ordinance and other relevant laws and regulations of the training.

    Medical device advertising review agencies and the advertising supervision and administration authorities of dereliction of duty, abuse of power, favoritism, and shall be given administrative sanctions in accordance with the relevant provisions constitutes a crime, criminal responsibility shall be investigated according to law. 27th medical equipment approval number for "x-wide medical device (as) No. 0000000000", "x-wide medical device (sound) No. 0000000000", "x-wide medical device trial (article) No. 0000000000." Where "x" for each province, autonomous region, municipality directly under the acronym "0" up to 10 digits, representative of the top 6 reviews, 4 representatives of their approval after the serial number.

    "" "" "" The classification of representative form for advertising media code. 28th article this way come into force on May 20, 2009. Released on March 8, 1995, review of the medical device advertising policy (for industry and commerce, the State pharmaceutical administration orders 24th) repealed simultaneously.