Advertising and promotion of NMPA-registered medical devices in China are governed by strict regulations designed to protect public health, ensure the safety of medical devices, and prevent misleading claims or inappropriate marketing practices. The NMPA (National Medical Products Administration) and other relevant regulatory bodies, such as the State Administration for Market Regulation (SAMR), enforce these rules.

Here’s a detailed overview of the advertising and promotion guidelines for NMPA-registered medical devices in China:

1. General Principles for Advertising Medical Devices

1.1. Truthfulness and Accuracy

• All advertising and promotional materials must be truthful, accurate, and scientifically supported. Claims made in advertisements must not exaggerate the efficacy or performance of the medical device.
• Medical device advertisements must not contain misleading or deceptive statements. This includes false claims about the device's functionality, effectiveness, safety, or any other characteristics.

1.2. No Unauthorized Claims

• It is prohibited to advertise medical devices in ways that imply they have uses or benefits that have not been authorized by the NMPA. Only the indications, contraindications, and claims explicitly approved by NMPA for the device can be used in marketing materials.
• Medical devices must not be promoted as “cures” or “miracle solutions” for serious diseases unless such claims are supported by clinical evidence and authorized by the NMPA.

1.3. Compliance with NMPA Certification

• Only NMPA-registered medical devices can be marketed in China. Advertising materials must clearly indicate the device's registration status with the NMPA. If applicable, the device should display the NMPA registration number or certificate details.

1.4. Clinical Data and Evidence

• Any claims made in advertisements regarding clinical benefits, performance, or effectiveness must be backed by clinical data and other supporting evidence. This can include data from clinical trials, studies, or real-world evidence.
• Peer-reviewed publications or clinical trial results should be referenced to substantiate claims, particularly for more high-risk or advanced devices (Class II or III).

1.5. Prohibition of False Representation

• Manufacturers must avoid false representations of the device’s status, such as implying that a device has been authorized by the NMPA when it has not, or suggesting the device is endorsed by governmental or regulatory authorities without justification.

2. Specific Advertising Restrictions for Medical Devices

2.1. Banning of Promotional Activities in Certain Settings

• Hospitals and healthcare institutions are prohibited from conducting promotional activities or directly advertising medical devices. Medical devices cannot be marketed to patients in these settings through direct advertising by manufacturers.
• Public places: Advertising of medical devices is also restricted in certain public spaces to prevent consumer confusion or exploitation, particularly when the advertising could influence individuals who are not healthcare professionals.

2.2. Social Media and Online Advertising

• Social media platforms and e-commerce websites are growing in importance for marketing medical devices. However, advertising on these platforms is strictly regulated.
  • Ads must comply with SAMR regulations, and the content must not mislead consumers about the nature of the device or its uses.
  • Any promotion must clearly identify the manufacturer and the NMPA registration number (if applicable).
  • E-commerce platforms like Alibaba and JD.com must ensure that only registered and approved medical devices are advertised and sold through their channels.

2.3. Use of Medical Professionals and Testimonials

• Medical professionals can endorse a device, but only in specific and carefully controlled contexts. They cannot make exaggerated or unsubstantiated claims about the device.
• Testimonials from patients or healthcare providers should be based on actual experiences and substantiated by clinical data. Testimonials cannot be used to create false or misleading expectations about a device’s performance.
  • Testimonials should not claim that the device cures or prevents diseases that are outside the approved indications.
  • Compensation for testimonials: If testimonials are compensated (e.g., doctors or patients are paid to promote the device), the advertisement must disclose this information.

2.4. Use of Specific Terminology

• Certain terms are prohibited or require special consideration:
  • “Cure” or “Prevention”: These terms cannot be used unless the device has been explicitly authorized for such purposes by the NMPA.
  • "Best," "Most Effective," or "No Risk": Absolute terms implying superiority, such as "best" or "most effective," are typically prohibited unless there is clear evidence supporting such claims.
  • "Approved by NMPA": Devices can only claim "approval" if they have been explicitly authorized by the NMPA. It is critical that promotional materials do not imply NMPA approval without providing proper context.

3. Required Elements in Advertising and Promotional Materials

3.1. Device Identification

• The advertisement must clearly identify the medical device being promoted, including the brand name, model number, and the NMPA registration number (or certificate).
• If the advertisement includes a clinical study, it must specify the source, including the name of the study and its publication, if applicable.

3.2. Clear and Accurate Indications

• The intended use of the device must be clearly stated in the advertisement, consistent with the indications approved by NMPA. Claims regarding off-label uses (those not approved by NMPA) are not permitted.
• Any warnings, precautions, and contraindications should also be included in promotional materials, especially when the device has risks associated with its use.

3.3. Manufacturer Information

• The advertisement must provide the name, contact details, and location of the manufacturer or the authorized representative in China. This ensures transparency and provides consumers with a point of contact for queries or complaints.

3.4. Compliance with Advertising Laws

• Medical device advertising in China must comply not only with NMPA guidelines but also with broader advertising laws in China, including the Advertising Law of the People’s Republic of China and SAMR regulations. These laws govern all forms of advertising and aim to protect consumers from false or misleading advertisements.

4. Advertising of Specific Types of Medical Devices

4.1. High-Risk Medical Devices (Class II & III)

• Advertising of Class II and III medical devices (medium to high-risk) faces stricter restrictions due to the higher potential risks posed by these devices.
• Clinical trials or approved studies are generally required to back up any claims made about safety or efficacy.
• These devices cannot be promoted directly to consumers or through public advertising; they may only be promoted to healthcare professionals.

4.2. Cosmetic or Aesthetic Medical Devices

• Devices intended for cosmetic purposes (e.g., dermal fillers, lasers for skin treatment) are also subject to advertising restrictions. These devices cannot be marketed as having medical properties unless they are explicitly authorized for such use by the NMPA.
• Medical aesthetics devices must ensure that any aesthetic claims (e.g., anti-aging, wrinkle removal) are scientifically supported and authorized by NMPA.

5. Penalties for Non-Compliance

• Fines and Penalties: Non-compliance with advertising regulations for medical devices in China can lead to serious penalties, including fines, suspension of product sales, or even a ban on marketing activities.
• Product Recall: If an advertisement is found to be misleading or harmful, the NMPA may order a recall or a halt to sales.
• Criminal Liabilities: In severe cases, misleading advertising could lead to criminal charges, especially if it results in harm to public health.

6. Best Practices for Medical Device Advertising in China

• Consult with Regulatory Experts: It is essential to work closely with regulatory consultants familiar with Chinese regulations to ensure full compliance.
• Ensure Clear Communication: Be transparent and clear in the advertising, ensuring that all claims are substantiated by NMPA-approved documentation.
• Monitor Advertising Channels: Regularly monitor advertising and promotional activities to ensure that they continue to comply with evolving regulations.

Conclusion

Advertising and promoting NMPA-registered medical devices in China require strict adherence to regulations to avoid misleading claims and ensure consumer safety. The key is to ensure that all advertisements are truthful, scientifically supported, and compliant with both NMPA and SAMR guidelines. By following these regulations and maintaining transparency, manufacturers can effectively promote their products in the Chinese market while protecting their reputation and avoiding legal issues.

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