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

Article 2: Advertisements published through certain media and forms that contain the name of a medical device, product scope of application, performance structure and composition, mechanism of action, etc. shall be reviewed in accordance with these Measures.

Ads that only promote the name of a medical device product do not need to be reviewed, but the medical device registration certificate number should be marked when advertising.

Article 3: Medical device advertisements applied for review can only be reviewed if they comply with the following laws, regulations and relevant provisions:

(1) "Advertising Law";

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

(3) "Standards for Review and Release of Medical Device Advertisements";

(4) Other national regulations on advertising management Regulation.

Article 4: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are the medical device advertising review agencies and are responsible for the review of medical device advertising within their respective administrative regions.

The industrial and commercial administration departments at or above the county level are the regulatory authorities for medical device advertising.

Article 5: The State Food and Drug Administration shall guide and supervise the medical device advertising review work of the medical device advertising review authorities, and shall deal with any violation of these Measures by the medical device advertising review authorities in accordance with the law.

Article 6: Applicants for medical device advertising approval numbers must be legally qualified medical device manufacturing companies or medical device operating companies. If a medical device business enterprise serves as an applicant, it must obtain the consent of the medical device manufacturer.

The applicant can entrust an agent to apply for the medical device advertising approval number. The agent should be familiar with the relevant national laws, regulations and provisions on advertising management.

Article 7: Application for a medical device advertising approval number shall be submitted to the medical device advertising review authority where the medical device manufacturer is located.

Applying for an imported medical device advertising approval number should be submitted to the medical device advertising review authority where the agent is located as listed in the "Medical Device Registration Form"; if the overseas medical device manufacturer of the product is located in If there is an organization within the country, the application shall be submitted to the medical device advertising review authority where the organization is located.

Article 8 To apply for a medical device advertising approval number, one must fill out the "Medical Device Advertising Review Form" and attach samples (samples, sample tapes) and medical device advertising electronic files that are consistent with the published content. At the same time, submit the following true, legal and valid supporting documents:

(1) A copy of the applicant’s “Business License”;

(2) The applicant’s “Medical Device Manufacturing Enterprise” License" or a copy of the "Medical Device Business Enterprise License";

(3) If the applicant is a medical device business enterprise, the original document proving that the medical device manufacturer agrees to be the applicant;

(4) If an agent applies for a medical device advertising approval number on his or her behalf, he or she shall submit the applicant’s original power of attorney and a copy of the agent’s business license and other documents proving the subject’s qualifications;

(5) A copy of the medical device product registration certificate (including the "Medical Device Registration Certificate", "Medical Device Registration Form", etc.);

(6) If you apply for an import medical device advertising approval number, A copy of the subject qualification certificate of the agent listed in the "Medical Device Registration Form" or the organization established in the country by the overseas medical device manufacturer shall be provided;

(7) Medical devices involved in the advertisement If registering trademarks, patents, certifications, etc., copies of relevant valid certification documents and other certification documents confirming the authenticity of the advertising content should be submitted.

Provide copies of the certification documents specified in this article, which must be signed and confirmed by the certificate holder.

Article 9 If any of the following circumstances occurs, the medical device advertising review authority will not accept the enterprise’s application for advertising of this type of medical device:

(1) It falls under Article 10 of these Measures The circumstances of inadmissibility specified in Articles 7, 19 and 20;

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

Article 10: After receiving the application for medical device advertising approval number, the medical device advertising review authority will issue a "Medical Device Advertising Acceptance Notice" if the application materials are complete and meet legal requirements; if the application materials are not If the application materials are complete or do not meet the statutory requirements, the applicant shall be notified on the spot or within 5 working days of all the content that needs to be supplemented and corrected; if the application materials are not notified within the time limit, the application shall be accepted from the date of receipt of the application materials.

Article 11: The medical device advertising review authority shall review the advertising content in accordance with the law within 20 working days from the date of acceptance. For medical device advertisements that pass the review, a medical device advertising approval number shall be issued; for medical device advertisements that fail to pass the review, a decision shall be made not to issue a medical device advertising approval number, and the applicant shall be notified in writing and the reasons shall be notified. Applicants have the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.

For approved medical device advertisements, the medical device advertisement review agency shall report to the State Food and Drug Administration for record. The State Food and Drug Administration shall instruct the medical device advertising review authority to correct medical device advertisements that have problems during registration.

For approved medical device advertisements, the drug regulatory department shall announce them to the public through the government website.

Article 12: Medical device advertising approval number is valid for one year.

Article 13: Approved medical device advertisements shall not change the content of the advertisement when it is released. If the content of a medical device advertisement needs to be changed, a new application for the medical device advertisement approval number shall be made.

Article 14 If a medical device advertising applicant publishes a medical device advertisement on its own, the original "Medical Device Advertising Review Form" shall be kept for 2 years for future reference.

Advertising publishers and advertising operators who are entrusted by advertising applicants to publish medical device advertisements shall inspect the original of the "Medical Device Advertising Review Form", publish it in accordance with the approved content, and submit the "Medical Device Advertising Review Form" A copy of the "Device Advertising Review Form" will be kept for 2 years for future reference.

Article 15: If an approved medical device advertisement falls into any of the following circumstances, the original approval medical device advertisement review authority shall conduct a reexamination. During the review period, the medical device advertisement can continue to be published:

(1) The State Food and Drug Administration believes that the content of the medical device advertisement approved by the medical device advertisement review authority does not comply with the regulations;

(2) The advertising supervision and management authority at or above the provincial level puts forward a review suggestion;

(3) Other circumstances where the medical device advertising review authority believes that review should be conducted.

If after review, it is believed that a medical device advertisement does not meet the statutory conditions, the medical device advertisement review authority shall make corrections, withdraw the "Medical Device Advertisement Review Form", and the medical device advertisement approval number shall be invalid.

Article 16 If any of the following circumstances occurs, the medical device advertising review authority shall cancel the medical device advertising approval number:

(1) The "Medical Device Advertising Approval Number" of the applicant for medical device advertising The "Device Manufacturing Enterprise License" and the "Medical Device Operating Enterprise License" are revoked;

(2) The medical device product registration certificate is revoked, revoked, or canceled;

( 3) The medical device ordered by the drug regulatory department to terminate the production, sale and use;

(4) Other situations where the administrative license should be canceled as stipulated by other laws and regulations.

Article 17 If the content of an approved medical device advertisement is tampered with to make false publicity, the drug regulatory department shall order the company to immediately stop publishing the medical device advertisement and revoke the enterprise’s approval document for the medical device advertisement of this type. No., the enterprise’s advertising approval application for this variety will not be accepted within one year.

Article 18 If advertisements for medical devices recommended to individuals contain content that seriously deceives and misleads consumers, such as arbitrarily expanding the scope of application of the medical device, absolute exaggerating the efficacy of the medical device, etc., the drug supervision and administration at or above the provincial level shall Once discovered, the department should take administrative coercive measures and suspend the sales of the medical device products within its jurisdiction until the enterprise that illegally published the advertisement eliminates the adverse effects.

If an enterprise that publishes advertisements illegally applies for the lifting of administrative compulsory measures, it must publish a correction notice in the corresponding media, and the advertisement must be published continuously for no less than 3 days; The management department provides the following materials:

(1) The original media or CD that published the "Correction Inspiration";

(2) The rectification report of the enterprise that illegally published medical device advertising;

(3) Application for lifting administrative compulsory measures.

The drug regulatory department that makes the decision on administrative compulsory measures will make a decision on whether to lift the administrative compulsory measures within 15 working days after receiving the materials submitted by the enterprise that illegally publishes medical device advertisements.

Article 19: If false materials are provided to apply for medical device advertising approval and are discovered by the medical device advertising review authority, the enterprise's advertising approval application for this type of product will not be accepted within one year.

Article 20: If false materials are provided to apply for medical device advertising approval and a medical device advertising approval number is obtained, the medical device advertising review authority shall revoke the medical device advertising approval number after discovery, and The enterprise's application for advertising approval of this variety will not be accepted within 3 years.

Article 21 Medical device advertisements with a medical device advertisement approval number shall be withdrawn, canceled or revoked in accordance with Articles 15, 16, 17 and 20 of these Measures. Publishing must cease immediately.

If the medical device advertising review authority withdraws, cancels or revokes the medical device advertising approval number in accordance with Articles 15, 16, 17 and 20 of these Measures, it shall report it in a timely manner The State Food and Drug Administration will also notify the advertising supervision and management authority at the same level within 5 working days from the date of making the administrative decision. If the advertisement continues to be published, it will be dealt with by the advertising supervision and management agency in accordance with the law.

Article 22: The drug regulatory department shall monitor and inspect the release of advertisements for medical devices that have been reviewed and approved. For illegally published medical device advertisements, the drug regulatory department shall fill out the "Illegal Medical Device Advertisement Transfer Notice" and transfer it together with illegal medical device advertisements and other samples to the advertising supervision and management agency at the same level for investigation and punishment.

If the content of an approved medical device advertisement is published in another place and tampered with, the medical device advertisement review authority at the place of release shall also propose to the original approval medical device advertisement review authority to revoke the approval of the medical device advertisement in accordance with Article 17 of these Measures. Document Number Suggestions.

Article 23: For serious cases of illegally released medical device advertisements, the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall make regular announcements and report them to the State Food and Drug Administration in a timely manner. Summarized and released by the Food and Drug Administration.

For serious cases of false medical device advertisements, the State Administration for Industry and Commerce and the State Food and Drug Administration will jointly make an announcement when necessary.

Article 24: If medical device advertisements released without review and approval and medical device advertisements released are inconsistent with the review and approval content, the advertising supervision and management agency shall comply with Article 43 of the Advertising Law Penalties are stipulated; if it constitutes false advertising or misleading false propaganda, the advertising supervision and management agency shall impose penalties in accordance with the relevant provisions of the Advertising Law or the Anti-Unfair Competition Law of the People's Republic of China and the State.

Article 25: When the advertising supervision and management agency investigates and handles illegal medical device advertising cases that involve the professional technical content of medical devices that needs to be identified, it shall notify the drug regulatory department at or above the provincial level of the content that needs to be identified. The drug supervision and administration department at or above the level shall feedback the determination results to the advertising supervision and administration authority within 10 working days after receiving the notice.

Article 26: Medical device advertising review staff and advertising supervision and management staff should receive training on relevant laws and regulations such as the Advertising Law and the Regulations on the Supervision and Management of Medical Devices. If staff members of medical device advertising review agencies and advertising supervision and management agencies neglect their duties, abuse their power, or practice favoritism for personal gain, they shall be given administrative sanctions in accordance with relevant regulations; if a crime is constituted, criminal liability shall be pursued in accordance with the law.

Article 27 The approval number for medical device advertising is "X Medical Equipment Guangshen (Sound) No. 0000000000", " Mechanical Guangshen (text) No. 0000000000." Among them, "X" is the abbreviation of each province, autonomous region, and municipality directly under the Central Government; "0" consists of ten digits. The first six digits represent the year and month of review, and the last four digits represent the serial number of advertising approval. "Visual", "sound" and "text" represent the classification codes used for advertising media forms.

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