Yes, NMPA registration for medical devices in China does involve regular verification and compliance requirements. Here’s an overview:

**1. Periodic Review:

• Registration Renewal: Medical device registration with the NMPA typically needs to be renewed periodically, usually every five years. This process involves submitting updated documentation and sometimes additional testing or evaluations.

**2. Post-Market Surveillance:

• Ongoing Compliance: Manufacturers must comply with post-market surveillance requirements, which include reporting adverse events, maintaining records of product performance, and conducting periodic reviews of product safety and effectiveness.

**3. Quality Management System (QMS) Audits:

• GMP Inspections: The NMPA may conduct regular inspections of manufacturing facilities to ensure ongoing compliance with Good Manufacturing Practices (GMP). These inspections help verify that the quality management system remains effective and compliant with Chinese regulations.

**4. Product Changes:

• Notification of Changes: Any significant changes to the product or its manufacturing process must be reported to the NMPA. This includes changes in design, production methods, or materials. Depending on the nature of the changes, additional reviews or approvals may be required.

**5. Market Surveillance:

• Regulatory Updates: The NMPA may require additional evaluations or modifications based on market surveillance findings or updates in regulations. Staying informed about changes in regulatory requirements is crucial for maintaining compliance.

Regular verification and adherence to NMPA requirements ensure continued market access and regulatory compliance for medical devices in China.