Effective May 20, 2009, China’s State Administration of Industry and Commerce (“SAIC”), the Ministry of Health (MOH), and the State Food & Drug Administration (“SFDA”) jointly issued “Measures for the Examination of Medical Device Advertisements” (“Measures”) and “Standards for the Examination and Release of Medical Device Advertisements” (“Standards”), both of which are relevant to medical device manufacturers and distributors advertising medical devices and diagnostic products within China.
According to the Measures, provincial Food and Drug Administrations (“FDAs”) are responsible for examining medical device advertisements, while local Administrations for Industry and Commerce (“AICs”) are responsible for monitoring public advertising of medical devices. Applicants seeking approval for medical device advertisements are required to be qualified medical device manufacturers or medical device distributors. In instances where the distributor is the applicant, medical device distributors require approval from the medical device manufacturer, valid for one year. If the content of the approved medical device advertisement is determined to be false or fraudulent, the supervising authority is required to withdraw the advertisement, cancel the corresponding advertisement’s approval number, and refuse to accept advertising applications related to the relevant medical device from the infringing company for one year. If medical device advertisements aimed at individuals exaggerate the benefits of the medical device or include any overly misleading claims, the supervisory drug authority at the Provincial-level or higher may prohibit sales of the medical device. If the advertiser refrains from using the improper advertisement, the company will be eligible to resume sales.
According to the Standards, advertisements are prohibited for medical devices whose production, sale, and use are subject to legal prohibition by SFDA, and for devices developed by medical institutions for internal use. Medical device advertisements are required to be accurate in describing the applicable scope and effectiveness of medical devices, and shall not use the names or images of medical research entities, academic organizations, medical organizations, experts, doctors, or patients as testimony to the effectiveness of the medical device being promoted. Chinese agencies with enforcement authority retain significant discretion in how to apply these new rules and interpretation may vary from region to region. The new rules encourage careful attention to all forms of advertising and close coordination with the relevant Chinese agencies.