State Council Legislative Affairs Office: Publication of medical device advertisements must be approved by the drug regulatory department

The Regulations of the People's Republic of China on the Supervision and Management of Medical Devices (Draft for Comment) issued by the Legislative Affairs Office of the State Council on the 6th stipulates that medical device advertisements should be authentic and legal, and must not contain false or exaggerated content. At the same time, such advertisements should also be approved by the food and drug supervision and administration department before they are released.

The draft of the Opinions stipulates that medical device advertisements shall be examined and approved by the registrant of the medical device, the food and drug supervision and administration department of the people's government of the province, autonomous region, and municipality directly under the central government where the filer is located, and obtain medical device advertisement approval documents. The food and drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall announce and promptly update the approved medical device advertising directory and the approved advertising content.

Advertising publishers who publish medical device advertisements shall review the approval documents of the advertisements in advance and verify their authenticity; they shall not publish medical device advertisements that have not obtained the approval document, whose authenticity of the approval document has not been verified or whose advertisement content is inconsistent with the approval document.