China Cracks Down on Illegal Medical Device Advertisements

On January 1, 2013, China’s SFDA launched a national database for monitoring the illegal advertising of drugs, medical devices, and health food products. The national SFDA has encouraged local agencies to make full use of the database. It has also required local agencies to file quarterly reports, which will be kept in the database for two years. The reports will be used to launch investigations and initiate criminal proceedings against violators of China’s advertising laws.

In addition to using the database, the SFDA has encouraged local agencies to strengthen supervision of illegally advertised products. According to a February 2013 notification:

  • Local SFDA offices are encouraged to strictly interpret the law if they encounter false advertising in the following categories: exaggerated product indications (including treatment function and scope of use), fake seals of approval, or misleading testimony from patients, doctors, medical professionals, officials or academics.
  • Investigating offices have the authority to give out administrative warnings, issue cease and desist orders and revoke the licenses of advertisers. These punishments will also be entered into the database.
  • For situations in which an illegally advertised product poses a serious public health risk, the local agency can obtain authorization from the provincial FDA to issue a temporary cease and desist order. All investigation results must be reported to the provincial FDA and to the public.

The notification is contingent on several Chinese laws and notifications, including Standards for Examining and Issuing Medical Device Advertisements (No. 40, 2009), Standards for Examining and Issuing Pharmaceutical Advertisements (No. 27, 2007) and Temporary Rules for the Examination of Health Products Advertisements (No. 211, 2005). While these laws have been in place for a while, the new national database will lead to more enforcement in China.