After obtaining NMPA registration for medical devices in China, manufacturers must adhere to specific advertising requirements to ensure compliance with regulations. Here are the key advertising requirements:

1. Compliance with Laws and Regulations

• Advertising Law: All advertising must comply with the Advertising Law of the People's Republic of China, which prohibits false or misleading claims.
• NMPA Guidelines: Follow the NMPA's guidelines for medical device advertising, which focus on safety, efficacy, and truthful representation.

2. Content Restrictions

• No Misleading Claims: Avoid making exaggerated claims about the device's effectiveness or safety. Claims must be supported by evidence and should accurately reflect the device's intended use.
• Prohibited Content: Advertisements must not include:
  • Unapproved uses
  • Comparisons with other medical devices
  • Testimonials or endorsements from unqualified individuals
  • Claims of curing diseases unless supported by clinical evidence

3. Approval for Promotional Materials

• Pre-Approval Requirement: Some promotional materials, especially those intended for healthcare professionals or the public, may require pre-approval from the NMPA. Ensure you check the specific requirements for your device category.

4. Clear Indication of Registration Status

• Registration Information: Clearly indicate the NMPA registration number in all advertisements. This helps verify the legitimacy of the product being advertised.

5. Target Audience Considerations

• Professional vs. Public Advertising: Tailor advertising content to the intended audience. Promotional materials aimed at healthcare professionals may include more technical information compared to those directed at consumers.

6. Documentation and Record Keeping

• Maintain Records: Keep detailed records of all advertising materials, including copies of ads and related correspondence. This documentation may be required for compliance audits or inspections.

7. Monitoring and Reporting

• Ongoing Monitoring: Continuously monitor the market for any feedback or adverse events related to your device. Be prepared to adjust advertising materials based on new information or regulatory updates.
• Adverse Event Reporting: If any adverse events occur that relate to advertising claims, manufacturers are required to report these to the NMPA promptly.

8. Penalties for Non-Compliance

• Legal Consequences: Non-compliance with advertising regulations can result in penalties, including fines, suspension of marketing activities, or revocation of registration.

Conclusion

Adhering to advertising requirements post-NMPA registration is crucial for maintaining compliance and protecting the integrity of the medical device market in China. Ensuring that all promotional materials are truthful, clear, and compliant with regulations will help avoid legal issues and build trust with consumers and healthcare professionals.

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