Effective May 20, 2009, the Chinese government issued two sets of regulations that are important for medical device manufacturers and distributors who advertise medical devices and diagnostic products:
- Measures for the Examination of Medical Device Advertisements
- Standards for the Examination and Release of Medical Device Advertisements
These regulations were issued by the State Administration of Industry and Commerce (SAIC), the Ministry of Health (MOH), and the State Food & Drug Administration (SFDA). This memo provides an English summary of key points contained in the regulations.
Measures for the Examination of Medical Device Advertisements1
The Measures were initially promulgated by the SAIC and the former State Medical Administration Bureau March 8, 1995, and then revised in April 2009.
According to the revised version, the local Food and Drug Administrations (FDAs) of provinces, autonomous regions, and municipalities falling directly under the central government, are responsible for the examination of medical device advertisements, while the local Administrations for Industry and Commerce (AICs) above county levels are responsible for monitoring public advertising of medical devices.
Applicants seeking approval for medical device advertisements must be qualified medical device manufacturers or medical device distributors. Medical device distributors need the approval of the medical device manufacturer where the distributor acts as the applicant. The approval is valid for one year.
The examination authority for medical device advertisements can cancel the approval under any of the following circumstances:
- The Medical Device Manufacturing Enterprise License or the Medical Device Distributing Enterprise License of the entity applying for the medical device advertisement is withdrawn
- The registration certificate of the medical device is withdrawn or cancelled
- The manufacturing, sales and/or use of the medical device is prohibited by SFDA or MOH
If the content of the approved medical device advertisement is determined to be false or fraudulent, the supervisory authority must withdraw the advertisement and cancel the approval number of the corresponding advertisement, and will refuse to accept the application for this medical device advertisement from the infringing company for one year.
If medical device advertisements aimed at individuals exaggerate the use of the medical device or include any severely misleading claims, the drug supervisory authority at the provincial level or above may prohibit sales of the medical device. If the advertiser eliminates the improper advertisement, the company will be eligible to resume sales.
Standards for the Examination and Release of Medical Device Advertisements2
The Standards were first promulgated March 3, 1995 by SAIC. The new Standards restrict advertisements pertaining to the following medical devices:
- Medical devices, the production, sales and use of which are subject to legal prohibition by SFDA
- Medical devices that medical institutions develop for internal use
In advertisements for medical devices, the name of the approved medical device and its manufacturer, the registration number of the medical device, and the approval number of the medical device advertisement must all be included.
Medical device advertisements shall be accurate in describing the applicable scope and effectiveness of medical devices, and shall not include:
- Assertion or guarantee of effectiveness
- Description of the efficacy rate or recovery rate
- Comparison to other medical devices, drugs or therapies in effectiveness or safety
- Non-scientific description of the characteristics or mechanisms of medical devices or terms that are beyond the registration certificate
- Research findings that cannot be confirmed
- Description or implications of the device being a panacea or "cure-all"
- Promising words such as "safe," "no side effect," "refund if ineffective," or absolute or exclusive words such as "only," "exact," "newest technology," "most advanced science," "state-level product," "fill in the product gap in the country," etc.
- Words that indicate or imply that the medical device is necessary for daily life or curing of diseases
- Words that indicate or imply that the medical device may help the user deal with common life pressures or difficulties, help to improve performance, make the user more energetic, taller or more talented, etc.
Medical device advertisements 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.
The Chinese agencies with enforcement authority retain significant discretion in how to apply these new rules. Accordingly, interpretations may vary from region to region. As these new rules are implemented, manufacturers should carefully review all forms of advertising and continue to coordinate closely with the Chinese review agencies.