The second through certain media and forms of advertising containing the name of the medical device, the scope of application of the product, the performance of the structure and composition, mechanism of action, etc., shall be reviewed in accordance with these measures.
Only advertise the name of the medical device product does not need to review the advertisement, but in the publicity should be labeled with the medical device registration number.
Article 3 The application for review of medical device advertisements, in line with the following laws and regulations and relevant provisions, can be passed through the review:
(1) "Advertising Law";
(2) "Regulations on the Supervision and Administration of Medical Devices";
(3) "Medical Device Advertisement Review and Publication Standards";
(4) the state related to the management of advertising and other provisions. Other regulations.
Article 4 The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government are the reviewing authorities of medical device advertisements, and are responsible for reviewing the advertisements of medical devices in the administrative regions.
Administration for industry and commerce at or above the county level is the supervision and management of medical device advertising authority.
Article V. The State Food and Drug Administration shall direct and supervise the review of medical device advertisements of the medical device advertising review authority, and shall deal with the violation of these measures by the medical device advertising review authority according to law.
Article VI of the medical device advertising approval number of the applicant must be legally qualified medical device manufacturers or medical device business enterprises. Medical device business enterprises as the applicant, must obtain the consent of the medical device manufacturer.
The applicant can appoint a representative to handle the medical device advertising approval number of the application. The agent should be familiar with the relevant state laws, regulations and provisions of the advertisement management.
Article 7 The application for approval number of medical device advertisement shall be submitted to the medical device advertisement examination authority where the medical device manufacturer is located.
Applications for the approval number of imported medical device advertisements shall be made to the medical device advertisement examination authority at the location of the agent listed in the Registration Form of Medical Devices; if the overseas medical device manufacturer of the product has an organization within the country, the application shall be made to the medical device advertisement examination authority at the location of the organization.
Article 8 The application for approval number of medical device advertisement shall be made by filling in the Medical Device Advertisement Examination Form and attaching the sample (sample film, sample tape) and electronic file of the medical device advertisement consistent with the content of the release, and at the same time, submitting the following true, lawful, and effective supporting documents:
(1) a copy of the applicant's "Business License;"
(2) the applicant's "Medical Device Manufacturer's License" or "Medical Device Manufacturer's License" or "Medical Device Manufacturer's License" or "Medical Device Manufacturer's License". Medical Device Manufacturer's License" or "Medical Device Operator's License" copy;
(c) the applicant is a medical device business enterprise, should be submitted to the medical device manufacturer to agree to its original documents as the applicant;
(d) on behalf of the proxy for the application for approval of medical device advertising, should be submitted to the applicant's original power of attorney and the proxy Business license copy of the main qualification documents;
(E) medical device product registration certificate (including "Medical Device Registration Certificate", "Medical Device Registration Form", etc.) a copy of the certificate;
(F) application for approval of the number of imports of medical devices advertising, should provide the "Medical Device Registration Form" listed in the agent or overseas medical device manufacturers in the territory of the main qualification of the organization set up A copy of the main qualification documents of the organization set up;
(vii) If the advertisement involves registered trademarks, patents, certifications of medical devices, etc., a copy of the relevant valid certificates and other documents confirming the authenticity of the content of the advertisement shall be submitted.
Provide a copy of the documents specified in this article, the document holder is required to sign to confirm.
Article IX of the following circumstances, the medical device advertising review authority shall not accept the application of the enterprise the variety of medical device advertising:
(A) belonging to the provisions of Article 17, Article 19, Article 20 of the inadmissibility of the situation;
(B) revocation of the approval number of medical device advertising administrative procedures are being implemented.
Article X of the medical device advertising review authority receives an application for approval of medical device advertising, the application materials are complete and meet the statutory requirements, issued by the "Medical Device Advertising Acceptance Notice"; application materials are incomplete or do not meet the statutory requirements, the applicant shall be informed on the spot or within five working days at a time to make corrections to all the contents of the applicant; late notification, since the date of receipt of the application materials shall be deemed admissible. The date of receipt of the application materials shall be accepted.
Article XI of the medical device advertising review authority shall, within 20 working days from the date of acceptance, review the content of the advertisement according to law. The review of qualified medical device advertisements, issued to the approval number of medical device advertisements; review of unqualified medical device advertisements, shall make a decision not to issue the approval number of medical device advertisements, notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or to bring an administrative lawsuit according to law.
On the approval of medical device advertising, medical device advertising review authority shall report to the State Food and Drug Administration for the record. The State Food and Drug Administration for the record of medical device advertisements, there are problems, should be instructed to medical device advertising review authority to be corrected.
The approved medical device advertisements, drug supervision and management department shall be announced through the government website to the community.
Article XII of the medical device advertising approval number is valid for one year.
Article XIII of the approved medical device advertisements shall not change the content of the advertisement at the time of publication. If the content of the medical device advertisement needs to be changed, it shall reapply for the approval number of medical device advertisement.
Article XIV of the medical device advertising applicants to publish their own medical device ads, should be the "medical device advertising review form" original saved for two years for inspection.
Advertisers and advertisers entrusted by the applicant to act as an agent for the release of medical device advertisements, shall check the original "Medical Device Advertisement Review Form", and publish the content in accordance with the review and approval, and keep a copy of the "Medical Device Advertisement Review Form" for 2 years for inspection.
Article 15 has been approved by the medical device advertising, one of the following circumstances, the original approval of the medical device advertising review body for review. During the review, the medical device advertisement can continue to be published:
(1) The State Food and Drug Administration considers that the content of the medical device advertisement approved by the medical device advertisement reviewing authority is not in conformity with the regulations;
(2) the advertisement supervisory and administrative authorities above the provincial level put forward the suggestion of review;
(3) the medical device advertisement reviewing authority considers that the advertisement should be reviewed in other cases. circumstances.
After review, the medical device advertising does not meet the statutory conditions, the medical device advertising review authority shall be corrected, withdraw the "medical device advertising review form", the medical device advertising approval number is invalid.
Article XVI of the following circumstances, the medical device advertising review authority shall cancel the approval number of medical device advertising:
(1) medical device advertising applicant's "medical device manufacturer license", "medical device business enterprise license" has been revoked;
(2) the medical device product registration certificate has been withdrawn, revoked, canceled;
(3) medical device advertising applicants shall be corrected. p>
(C) drug supervision and management department ordered to terminate the production, sale and use of medical devices;
(D) other laws and regulations should be canceled administrative license.
Article XVII tampering with the contents of the approved medical device advertisement for false propaganda, by the drug supervision and management department ordered to immediately stop the release of the medical device advertisement, revoke the approval number of the medical device advertisement of the variety of the enterprise, 1 year will not accept the application for approval of the advertisement of the variety of the enterprise.
Article 18 Recommended to individuals to use the medical device advertising contains arbitrary expansion of the scope of application of medical devices, absolute exaggerated medical device efficacy and other serious deception and mislead consumers, the drug supervision and management departments at or above the provincial level upon discovery, shall take administrative coercive measures in the illegal publication of advertisements in the enterprise to eliminate the adverse effects of the suspension of the sale of the medical device products within the jurisdiction of the enterprise.
Enterprises that publish advertisements in violation of the law and apply for the lifting of administrative coercive measures must publish the Corrective Revelation in the corresponding media, and it shall be published for not less than three consecutive days; and at the same time, they shall provide the following materials to the drug supervision and management department that makes the decision on administrative coercive measures:
(1) the original copy of media that publishes the Corrective Revelation or the CD-ROM;
(2) the rectification report of the enterprise that publishes advertisements of medical devices in violation of the law medical device advertisement enterprise's rectification report;
(iii) application for lifting the administrative coercive measures.
The drug supervision and management department that makes the decision on the administrative coercive measures shall make a decision on whether to lift the administrative coercive measures within 15 working days after receiving the materials submitted by the enterprise that illegally publishes medical device advertisements.
Article XIX of the provision of false materials to apply for approval of medical device advertisements, found by the medical device advertising review authority, the enterprise will not be accepted within 1 year of the application for approval of the advertisement of the species.
Article 20 For the provision of false materials to apply for approval of medical device advertising, medical device advertising approval number, the medical device advertising review authority shall revoke the approval number of the medical device advertisement after discovery, and will not accept the application for approval of the advertisement of the variety of the enterprise within 3 years.
Article 21 In accordance with Article 15, Article 16, Article 17, Article 20 of these measures to withdraw, cancel or revoke the medical device advertising approval number of medical device advertising, must immediately stop publishing.
Medical device advertising review authority in accordance with Article 15, Article 16, Article 17, Article 20 of the recovery, cancellation or revocation of the approval number of medical device advertisements should be promptly reported to the State Food and Drug Administration, and at the same time in the date of the administrative decision to notify the advertising supervision and management authorities at the same level within five working days. The advertisements continue to publish, by the advertising supervision and management authorities shall be dealt with according to law.
Article 22 of the Drug Administration shall review and approve the release of medical device advertising monitoring and inspection. For the illegal release of medical device advertisements, the drug supervision and management department to fill out the "illegal medical device advertisements transfer notice", together with the illegal medical device advertisements and other samples, transferred to the same level of advertising supervision and management authorities to investigate and deal with.
It belongs to the off-site release of tampering with the content of the approved medical device ads, the release of medical device advertising review authority should also be to the original approval of the medical device advertising review authority in accordance with Article 17 of the revocation of the approval number of the medical device ads proposed.
Article 23 of the illegal release of medical device advertisements in serious cases, the provinces, autonomous regions and municipalities directly under the Central Drug Administration shall be regularly announced, and promptly reported to the State Food and Drug Administration, the State Food and Drug Administration summary release.
The release of false medical device advertisements under serious circumstances, if necessary, by the State Administration for Industry and Commerce in conjunction with the State Food and Drug Administration to be jointly announced.
Article 24 Without examination and approval of the release of medical device advertisements as well as the release of medical device advertisements inconsistent with the examination and approval of the content of the advertisement, the advertising supervision and management authorities shall be punished in accordance with the provisions of Article 43 of the "Advertising Law"; constitutes a false advertisement or misleading false propaganda, the advertising supervision and management authorities shall be punished in accordance with the "Advertising Law" or the "People's Republic of China*** and the State Anti-fair Competition Law" relevant provisions of the advertisement. Law of the People's Republic of China and the State Anti-Unfair Competition Law shall be punished in accordance with the relevant provisions.
Article 25 The advertising regulatory authorities shall investigate and handle the cases of illegal medical device advertisements, and if it involves the need to identify the professional and technical contents of the medical devices, they shall notify the drug regulatory authorities at or above the provincial level of the contents that need to be identified, and the drug regulatory authorities at or above the provincial level shall feedback the results of the identification to the advertising regulatory authorities within 10 working days after the receipt of the notification letter.
Article 26 The medical device advertising review staff and advertising supervision and management staff shall be trained in the Advertising Law, Regulations for the Supervision and Administration of Medical Devices and other relevant laws and regulations. Medical device advertising review authorities and advertising supervision and management authorities of the staff negligence, abuse of power, favoritism and malpractice, shall be given administrative sanctions in accordance with the relevant provisions; constitutes a crime, shall be investigated for criminal responsibility.
Article 27 The approval number of medical device advertisements is "X Medical Equipment Guangqi (visual) No. 0000000000", "X Medical Equipment Guangqi (sound) No. 0000000000", "" X Medical Device Guangqian (Wen) No. 0000000000". Which "X" for the provinces, autonomous regions and municipalities directly under the Central Government's abbreviation; "0" consists of ten digits, the first six on behalf of the review of the year and month, the last four on behalf of the ads approved by the serial number. The "visual", "sound" and "text" represent the classification codes used for advertising media forms.
Article 28 These Measures shall come into force on May 20, 2009. March 8, 1995 release of the "Medical Device Advertising Review" (State Administration for Industry and Commerce, the State Administration of Pharmaceutical Affairs Decree No. 24) shall be repealed simultaneously.