After obtaining Class I medical device registration with China's National Medical Products Administration (NMPA), there are several key considerations to ensure ongoing compliance and successful market presence:

1. Post-Market Surveillance (PMS):

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

2. Quality Management System (QMS) Maintenance:

   • Continue to maintain and update your Quality Management System (QMS) in accordance with ISO 13485 or equivalent standards. Regular audits and assessments should be conducted to ensure ongoing compliance with regulatory requirements.

3. Labeling and Packaging Compliance:

   • Ensure that labeling and packaging of your device comply with Chinese regulations, including requirements for symbols, instructions for use (IFU), and any updates or changes mandated by the NMPA.

4. Adverse Event Reporting:

   • Establish procedures for timely reporting of 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. Local Agent Responsibilities:

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

7. Market Feedback and User Training:

   • Gather feedback from users and healthcare providers regarding the performance and usability of your device. Consider providing training and educational materials to ensure correct usage and optimize device outcomes.

8. Compliance with Standards and Guidelines:

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

9. Clinical Data and Updates:

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

10. Post-Market Surveillance Reporting:

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

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn