After a medical device is registered with the National Medical Products Administration (NMPA) in China, manufacturers and distributors must comply with specific advertising regulations to promote their devices legally. The advertising of medical devices in China is highly regulated to ensure that the public receives accurate and non-misleading information about these products. Violations of these regulations can lead to penalties, fines, and even product recalls.

Key Advertising Requirements for Medical Devices Post-NMPA Registration:

1. General Principles of Medical Device Advertising

• Accuracy and Truthfulness: All advertising must be accurate, truthful, and non-misleading. Claims about the device's effectiveness, safety, and intended use must be supported by sufficient evidence, typically from the clinical trials and testing done for the NMPA registration.
• No False or Exaggerated Claims: Advertisements cannot make claims that cannot be substantiated through scientific or clinical data. For example, devices cannot claim to cure diseases unless they have been proven and approved by the NMPA for such use.
• Compliance with Relevant Regulations: Medical device advertising in China must comply with the Advertising Law of the People’s Republic of China and specific regulations from the NMPA. The advertising must also align with the Medical Device Supervision and Administration Regulations and related national standards.

2. Approval of Medical Device Advertising

• Pre-approval Requirement: Advertising for Class II and Class III medical devices generally requires prior approval from the NMPA or its local counterparts. This process is mandatory for all medical device advertisements, whether in print, online, or broadcast media.
  • Advertising Approval Process: Before the advertisement is published, the local NMPA office (or relevant administrative department) must review and approve it, especially if it includes claims related to safety, effectiveness, or treatment. The NMPA will verify the device's registration details and ensure that the claims in the advertisement align with the approved product specifications.
• Submission of Materials: Manufacturers or their local agents are required to submit the advertising materials to the NMPA for review. This may include:
  • Draft advertisements (including text, images, videos, etc.).
  • Supporting documents that verify claims made in the advertisement (e.g., clinical data, test reports).
  • Product registration certificate and other official documentation.
  • Verification of Compliance: The NMPA or relevant authority will confirm that the advertisement aligns with the product’s approved labeling and intended use as per the Medical Device Registration Certificate (MDRC).

3. Prohibited Content in Medical Device Advertisements

The NMPA has specific rules on what can and cannot be included in medical device advertising:

• No False or Unsupported Health Claims: Ads cannot claim that a device can cure, prevent, or treat diseases unless these claims have been explicitly authorized by the NMPA. For example, a diagnostic device cannot claim to cure a medical condition unless the NMPA has approved it as such.
• No Comparison with Other Devices: Advertisements should not make direct comparisons between products unless such comparisons are scientifically validated and supported by the NMPA.
• No Superlative Language: Terms like "best," "most effective," or "number one" are generally prohibited, as they can be misleading and are often not backed by evidence.
• No Unsubstantiated Test Results: Any test results or data presented in advertisements must be reliable, scientifically valid, and auditable. All test reports and clinical data should be available for verification if requested by regulatory authorities.
• No Misleading Visuals or Claims: Advertisements cannot use images or graphics that create a misleading impression of the device’s functionality. For example, a surgical device cannot be shown performing a procedure if the device is not approved for such use.
• Prohibition on Personal Endorsements: Use of personal endorsements (such as testimonials from doctors or patients) is restricted. Any testimonial or endorsement must be backed by evidence of the claims and must comply with regulations.

4. Advertising Content Guidelines

• Labeling and Claims: Advertisements must adhere to the approved labeling and product instructions provided during the NMPA registration process. Any statement made in advertising must be directly traceable to the device's clinical trial results, product specifications, or other NMPA-approved documentation.
• Restricted Terminology: Medical devices should not be described using terms like "miracle," "instant," or "totally safe" unless the claims are scientifically substantiated and align with the device's approved use.
• Language Requirements: All advertisements must be in Chinese. If the advertisement includes foreign language materials, a Chinese translation must be provided, and the translated content must align with the original content in terms of accuracy and compliance with NMPA regulations.

5. Advertising Platforms and Media

• Traditional Media (TV, Print, etc.): Advertisements in traditional media such as TV, radio, and newspapers must be submitted for approval prior to broadcasting or publication.
• Online and Digital Media: Medical device advertisements on websites, e-commerce platforms, and social media are also subject to NMPA review. Any form of digital marketing (such as pay-per-click ads, sponsored posts, or social media influencers) must be compliant with the regulatory standards and must undergo pre-approval.
  • E-commerce Platforms: If a medical device is sold online (e.g., through Alibaba, JD.com, or other platforms), advertising materials, product descriptions, and online claims are subject to the same review process as traditional media.
• Medical Conferences and Exhibitions: If advertising occurs at medical exhibitions or trade shows, all materials must also comply with the NMPA’s rules on medical device advertising. Promotional literature, presentations, and banners displayed at events need prior approval.

6. Post-Market Surveillance and Compliance

• Ongoing Monitoring: The NMPA conducts post-market surveillance to monitor compliance with advertising regulations. If any violations or complaints are identified (e.g., misleading claims or non-compliant advertisements), the NMPA may take corrective actions.
• Consequences for Violations: Companies found in violation of advertising regulations may face penalties, including:
  • Fines and sanctions.
  • Suspension or revocation of device registration.
  • Recall of non-compliant advertising materials.
  • Product recall or suspension if the advertising includes false or harmful claims.

7. Special Considerations for New Devices

• New Product Advertising: For new devices or innovations that have recently been registered with the NMPA, the advertising must be especially careful to avoid making unapproved or premature claims about their effectiveness.
• Clinical Data and Validation: Any new device advertisement must be backed by clinical data that supports its claims, particularly when the device is still undergoing clinical trials or has only recently been approved.

Summary of Key Steps for Compliant Medical Device Advertising in China:

1. Pre-Approval: Obtain approval from the NMPA for all advertisements before publishing or broadcasting.
2. Accurate and Supported Claims: Ensure all claims are truthful, accurate, and supported by clinical data or testing results.
3. Follow the NMPA Guidelines: Ensure the advertisement aligns with NMPA’s regulatory requirements, including product specifications, labeling, and language.
4. No Misleading Content: Avoid exaggerated claims, personal endorsements, and unverified or unsupported test results.
5. Ongoing Compliance: Monitor and manage post-market surveillance and be prepared to modify or withdraw advertisements that do not comply with the regulations.

By adhering to these requirements, manufacturers can avoid regulatory penalties and ensure their medical device advertising remains compliant with Chinese law, helping to build trust and credibility with Chinese consumers and healthcare professionals.