Updating NMPA-registered medical devices in China involves adhering to specific time requirements and audit standards. Here’s a summary of the key aspects:

### Time Requirements

1. **Registration Renewal**:

   - Medical device registrations generally need to be renewed every **five years**. Companies must submit a renewal application before the expiration date.

2. **Changes to Registration**:

   - If there are significant changes to a registered device (e.g., changes in design, manufacturing processes, indications for use), the manufacturer must file for a **supplementary application**. The NMPA will assess the changes, and the timeframe for approval can vary, typically taking **3 to 6 months**.

3. **Post-Market Surveillance**:

   - Manufacturers are required to conduct post-market surveillance and report any adverse events or product quality issues within **15 days** of becoming aware of the issue.

### Audit Standards

1. **Quality Management System (QMS)**:

   - Manufacturers must comply with the **GB/T 19001-2016/ISO 9001:2015** standard, which outlines the requirements for a quality management system.

2. **Clinical Evaluation**:

   - For Class II and Class III devices, clinical evaluation data must be updated to reflect any changes in the device or its intended use. This may involve conducting new clinical trials, depending on the extent of the modifications.

3. **Documentation**:

   - Complete and accurate documentation must be maintained and updated as part of the regulatory compliance process. This includes technical files, risk management reports, and clinical evaluation reports.

4. **NMPA Audits**:

   - The NMPA conducts regular audits of manufacturers to ensure compliance with regulatory requirements. These audits can happen during the initial registration process, renewal, or when significant changes are made.

5. **Post-Market Inspections**:

   - The NMPA may also carry out post-market inspections to ensure ongoing compliance and to evaluate the safety and efficacy of the device in real-world conditions.

### Conclusion

Staying compliant with NMPA regulations for updating registered medical devices requires careful planning and timely submission of required documentation. Manufacturers should maintain a robust quality management system and be prepared for both scheduled and unscheduled audits by the NMPA.

If you need more specific details or have questions about a particular aspect of the process, feel free to ask!

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