After applying for Class I medical device registration with China's National Medical Products Administration (NMPA) and obtaining approval, several regulations and requirements must be followed to ensure ongoing compliance and successful market presence:

1. Post-Market Surveillance (PMS):

   • Implement and maintain a post-market surveillance system to monitor the safety and performance of your device once it is on the market. This includes collecting and analyzing feedback, complaints, adverse events, and other relevant data from users and healthcare professionals.

2. Quality Management System (QMS) Maintenance:

   • Continue to uphold your QMS in accordance with ISO 13485 or an equivalent standard. Conduct regular audits and assessments to ensure compliance with regulatory requirements.

3. Labeling and Packaging Compliance:

   • Ensure that labeling and packaging of your device continue to comply with Chinese regulations, including requirements for symbols, IFU, and any updates mandated by the NMPA.

4. Adverse Event Reporting:

   • Establish procedures for promptly reporting adverse events related to your device as per Chinese regulatory requirements. Adhere to reporting timelines and communicate effectively with the NMPA regarding any incidents.

5. Regulatory Updates and Renewals:

   • Stay informed about changes in Chinese regulations that may affect your device. Monitor regulatory updates from the NMPA and ensure timely renewal of your device registration as required.

6. Clinical Data and Updates:

   • Maintain the integrity and relevance of clinical data, especially if ongoing studies or evaluations are needed to support the safety and efficacy of your device.

7. Market Feedback and User Training:

   • Gather feedback from users and healthcare providers on device performance and usability. Provide training and educational materials to ensure proper device usage and optimize outcomes.

8. Compliance with Standards and Guidelines:

   • Continuously assess and update your device to comply with relevant Chinese standards and guidelines, including any new or revised standards issued by the NMPA or international organizations.

9. Post-Market Surveillance Reporting:

   • Regularly report the results of post-market surveillance activities to the NMPA as required, demonstrating transparency and compliance with regulatory obligations.

10. Local Agent Responsibilities:

    • Maintain regular communication and collaboration with your local agent in China. They play a vital role in facilitating regulatory compliance, communication with authorities, and handling queries or inspections from the NMPA.

11. Regulatory Inspections and Audits:

    • Be prepared for potential regulatory inspections or audits by the NMPA to verify compliance with regulatory requirements and standards.