Yes, NMPA (National Medical Products Administration) registration for medical devices in China includes provisions for regular checks and post-market surveillance to ensure ongoing compliance and safety. Here are key aspects related to regular checks:

1. Post-Market Surveillance (PMS):

   • Manufacturers are required to implement post-market surveillance activities to monitor the performance and safety of their devices after they have been placed on the market.
   • PMS activities typically include collecting and analyzing data on adverse events, complaints, device malfunctions, and other relevant information from users and healthcare professionals.
   • The purpose of PMS is to detect any potential issues or trends that may affect device safety or performance and to take appropriate corrective actions if necessary.

2. Periodic Safety Updates:

   • Manufacturers must provide periodic safety updates to NMPA, detailing the results of post-market surveillance activities and any actions taken in response to identified issues.
   • These updates ensure that NMPA remains informed about the ongoing safety profile of registered devices and can intervene if there are concerns about device safety or performance.

3. Inspections and Audits:

   • NMPA may conduct inspections or audits of registered manufacturers to verify compliance with regulatory requirements, including adherence to good manufacturing practices (GMP) and quality management systems (QMS).
   • Inspections may be scheduled or conducted based on risk assessment, and they serve to verify that manufacturing facilities and processes continue to meet regulatory standards.

4. Recalls and Field Corrective Actions:

   • In cases where serious safety issues are identified, NMPA may require manufacturers to initiate recalls or field corrective actions to address the issue promptly and mitigate risks to users.
   • Manufacturers are obligated to cooperate with NMPA in executing recall actions and providing timely notifications to affected stakeholders.

Overall, NMPA registration includes provisions for ongoing monitoring and regulatory oversight to ensure that registered medical devices continue to meet safety, efficacy, and quality standards throughout their lifecycle in the Chinese market. Manufacturers must maintain vigilance through post-market surveillance and compliance with regulatory obligations to uphold the integrity of their NMPA registrations.