Advertising laws and regulations stipulate the language specification of medical device advertising.

Article 1 In order to strengthen the management of medical device advertisements and ensure the authenticity and legality of medical device advertisements, these Measures are formulated in accordance with the Advertising Law of People's Republic of China (PRC) (hereinafter referred to as the Advertising Law), the Law of People's Republic of China (PRC) on Anti-Unfair Competition, the Regulations on the Supervision and Administration of Medical Devices and the relevant national regulations on the supervision and administration of advertisements and medical devices.

Article 2 Advertisements containing the names of medical devices, product application scope, performance structure, components and action mechanism published through certain media and forms shall be reviewed in accordance with these Measures.

Advertisements that only promote the name of medical devices need not be censored, but the registration number of medical devices should be marked when promoting.

Article 3 Medical device advertisements applying for examination shall comply with the following laws, regulations and relevant provisions before they can pass the examination:

(1) advertising law;

(2) Regulations on the Supervision and Administration of Medical Devices;

(3) Standards for the examination and publication of medical device advertisements;

(four) other provisions of the state on advertising management.

Article 4 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government are the examination organs of medical device advertisements, and are responsible for the examination of medical device advertisements within their respective administrative areas.

The administrative department for industry and commerce at or above the county level is the supervision and administration organ of medical device advertisements.

Article 5 The State Food and Drug Administration of the United States shall guide and supervise the medical device advertisement examination work of the medical device advertisement examination organ, and deal with the violation of these Measures by the medical device advertisement examination organ according to law.

Article 6 The applicant for the medical device advertisement approval number must be a legally qualified medical device manufacturer or medical device management enterprise. As an applicant, a medical device business enterprise must obtain the consent of the medical device manufacturing enterprise.

The applicant may entrust an agent to apply for the approval number of the medical device advertisement. Agents should be familiar with national laws, regulations and rules on advertising management.

Article 7 An application for a medical device advertisement approval number shall be submitted to the medical device advertisement examination organ where the medical device manufacturer is located.

The application for the approval number of imported medical device advertisements shall be submitted to the medical device advertisement examination organ at the place where the agent is located listed in the Medical Device Registration Form; Where an overseas medical device manufacturer of products has an institution within the territory of China, it shall submit it to the medical device advertisement examination organ where the institution is located.

Article 8 To apply for the approval number of medical device advertisements, the Examination Form of Medical Device Advertisements shall be filled in, and samples (samples, tapes) and electronic documents consistent with the contents of medical device advertisements shall be attached. At the same time, submit the following authentic, legal and valid documents:

(1) A copy of the applicant's business license;

(2) A copy of the applicant's License for Medical Device Manufacturing Enterprise or License for Medical Device Trading Enterprise;

(three) if the applicant is a medical device business enterprise, it shall submit the original certificate that the medical device manufacturing enterprise agrees to be the applicant;

(4) If the agent applies for the approval number of medical device advertisement on his behalf, it shall submit the original power of attorney of the applicant and a copy of the agent's business license and other subject qualification documents;

(5) Copy of medical device product registration certificate (including medical device registration certificate and medical device registration form);

(six) to apply for the approval number of the imported medical device advertisement, it shall provide a copy of the main qualification certificate of the agent or organization established in China by the overseas medical device manufacturer listed in the Medical Device Registration Form;

(seven) if the advertisement involves the registered trademark, patent and certification of medical devices, it shall submit a copy of the relevant valid certification documents and other certification documents to confirm the authenticity of the advertisement.

To provide a copy of the certification documents specified in this article, the certificate holder shall sign for confirmation.

Article 9 Under any of the following circumstances, the medical device advertisement examination organ shall not accept the application for advertising this variety of medical devices of the enterprise:

(a) the provisions of article seventeenth, nineteenth and twentieth of these measures shall not be accepted;

(2) The administrative procedure for revoking the approval number of medical device advertisements is in progress.

Article 10 After receiving the application for the approval number of medical device advertisement, the medical device advertisement examination organ shall issue a Notice of Acceptance of Medical Device Advertisement if the application materials are complete and meet the statutory requirements. If the application materials are incomplete or do not meet the statutory requirements, the applicant shall be informed of all the contents that need to be corrected on the spot or within 5 working days; Fails to inform, since the date of receipt of the application materials is accepted.

Eleventh medical device advertising examination organ shall, within 20 working days from the date of acceptance, examine the contents of advertisements according to law. The medical device advertisements that have passed the examination shall be issued with the approval number of the medical device advertisements; For medical device advertisements that fail to pass the examination, a decision shall be made not to issue the approval number of medical device advertisements, and the applicant shall be informed in writing and the reasons shall be explained. At the same time, the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

The medical device advertisement examination organ shall report the approved medical device advertisement to the State Food and Drug Administration for the record. The State Food and Drug Administration of the United States shall instruct the medical device advertisement examination organ to correct the problems existing in the filing.

The drug supervision and administration department shall announce the approved advertisements for medical devices to the public through the government website.

Twelfth medical device advertising approval number is valid for 1 year.

Thirteenth approved medical device advertisements shall not be changed after publication. If the contents of medical device advertisements need to be changed, it shall re-apply for the approval number of medical device advertisements.

Article 14 Where an applicant for medical device advertisements publishes medical device advertisements on his own, he shall keep the original medical device advertisement examination form for 2 years for future reference.

Advertisers and advertising agents who are entrusted by the advertising applicant to publish medical device advertisements shall review the original Medical Device Advertisement Examination Form, publish it according to the contents approved by the examination, and keep a copy of the Medical Device Advertisement Examination Form for 2 years for future reference.

Fifteenth approved medical device advertisements, in any of the following circumstances, shall be examined by the original medical device advertisement examination organ. During the review period, medical device advertisements can continue to be published:

(1) The State Food and Drug Administration of the United States considers that the contents of medical device advertisements approved by the medical device advertisement examination organ are not in conformity with the provisions;

(two) the advertising supervision and administration organs at or above the provincial level put forward examination suggestions;

(3) Other circumstances that the medical device advertisement examination organ thinks should be examined.

After examination, it is considered that the medical device advertisement does not meet the statutory requirements, and the medical device advertisement examination organ shall correct it and withdraw the medical device advertisement examination form, and the approval number of the medical device advertisement is invalid.

Article 16 Under any of the following circumstances, the medical device advertisement examination organ shall cancel the approval number of the medical device advertisement:

(a) the medical device advertising applicant's "medical device manufacturing enterprise license" and "medical device business enterprise license" have been revoked;

(2) The registration certificate of medical device products is revoked, revoked or cancelled;

(3) Medical devices ordered by the pharmaceutical supervisory and administrative department to stop production, sale and use;

(four) other laws and regulations shall cancel the administrative license.

Article 17 Whoever falsifies the contents of an approved medical device advertisement to make false propaganda shall be ordered by the pharmaceutical supervisory and administrative department to immediately stop publishing the medical device advertisement, revoke the approval number of the medical device advertisement of the enterprise, and refuse to accept the advertisement approval application of the enterprise within 1 year.

Article 18 Where advertisements for medical devices recommended to individuals contain contents that seriously deceive and mislead consumers, such as expanding the application scope of medical devices without authorization and absolutely exaggerating the efficacy of medical devices, the pharmaceutical supervisory and administrative department at or above the provincial level shall take administrative compulsory measures to suspend the sales of the medical device products within its jurisdiction until the enterprises that illegally publish advertisements eliminate the adverse effects.

If an enterprise that illegally publishes advertisements applies for lifting the administrative compulsory measures, it must publish the rectification enlightenment in the corresponding media, and the continuous broadcast shall not be less than 3 days; At the same time, provide the following materials to the pharmaceutical supervisory and administrative department that has made the decision on administrative compulsory measures:

(a) Original media or CD-ROM that releases corrective revelations;

(two) illegal release of medical device advertising enterprises rectification report;

(3) An application for lifting administrative compulsory measures.

The pharmaceutical supervisory and administrative department that made the decision on administrative compulsory measures shall make a decision on whether to lift the administrative compulsory measures within 15 working days after receiving the materials submitted by the enterprises that illegally publish advertisements for medical devices.

Article 19 If the application for examination and approval of medical device advertisements that provide false materials is discovered by the medical device advertisement examination organ, the application for examination and approval of this product advertisement of the enterprise will not be accepted within 1 year.

Article 20 Where a medical device advertisement approval number is obtained by providing false materials, the medical device advertisement examination organ shall revoke the medical device advertisement approval number after discovering it, and shall not accept the application for advertising approval of the product of the enterprise within three years.

Article 21 In accordance with Articles 15, 16, 17 and 20 of these Measures, the publication of medical device advertisements whose approval number is revoked, cancelled or revoked must be stopped immediately.

If the medical device advertisement examination organ revokes, cancels or revokes the approval number of the medical device advertisement according to Articles 15, 16, 17 and 20 of these Measures, it shall report to the State Food and Drug Administration in a timely manner and notify the advertising supervision and administration organ at the same level within 5 working days from the date of making the administrative decision. Those who continue to publish advertisements shall be dealt with by the advertising supervision and administration organs according to law.

Article 22 The pharmaceutical supervisory and administrative department shall supervise and inspect the advertising of medical devices that have been examined and approved. For illegal advertisements of medical devices, the drug supervision and administration department shall fill in the Notice of Transfer of Illegal Medical Device Advertisements and transfer them to the advertising supervision and administration organ at the same level for investigation.

If the content of the approved medical device advertisement is released in a different place, the medical device advertisement examination organ at the place of release shall also put forward a proposal to revoke the approval number of the medical device advertisement in accordance with the provisions of Article 17 of these Measures.

Article 23 If the circumstances of illegal advertisements for medical devices are serious, the pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall make regular announcements and report to the State Food and Drug Administration in a timely manner, which shall be summarized and published by the State.

If the circumstances of publishing false advertisements for medical devices are serious, the State Administration for Industry and Commerce shall make an announcement jointly with the State Food and Drug Administration when necessary.

Twenty-fourth medical device advertisements published without examination and approval and the published medical device advertisements are inconsistent with the contents of examination and approval, and the advertising supervision and management organs shall punish them according to the provisions of Article 43 of the Advertising Law; Those that constitute false advertisements or misleading false propaganda shall be punished by the advertising supervision and administration authorities in accordance with the relevant provisions of the Advertising Law or the Anti-Unfair Competition Law of People's Republic of China (PRC).

Article 25 When investigating and handling illegal medical device advertising cases, the advertising supervision and administration organ shall inform the drug supervision and administration department at or above the provincial level of the contents that need to be identified, and the drug supervision and administration department at or above the provincial level shall feed back the identification results to the advertising supervision and administration organ within 10 working days after receiving the notice.

Twenty-sixth medical device advertising examiners and advertising supervision and management personnel shall be trained in the Advertising Law, the Regulations on the Supervision and Administration of Medical Devices and other relevant laws and regulations. The staff of the medical device advertising examination organ and the advertising supervision and administration organ who neglect their duties, abuse their powers or engage in malpractices for selfish ends shall be given administrative sanctions in accordance with the relevant provisions; If a crime is constituted, criminal responsibility shall be investigated according to law.

Article 27 The approval numbers of medical device advertisements are "X Medical Device Guangshen (Vision) No.0000000", "X Medical Device Guangshen (Voice) No.0000000" and "X Medical Device Guangshen (Text) No.0000000". Where "X" is the abbreviation of all provinces, autonomous regions and municipalities directly under the Central Government; "0" consists of ten digits, with the first six digits representing the review year and the last four digits representing the advertisement approval number. "Vision", "sound" and "text" represent the classification codes used in the form of advertising media.

Article 28 These Measures shall come into force as of May 20, 2009. 1The Measures for Examination of Medical Device Advertisements (Order No.24 of the State Administration for Industry and Commerce and the State Administration of Medicine) issued on March 8, 1995 shall be abolished at the same time.