Updating NMPA-registered medical devices in China involves adhering to specific validity requirements and conditions for extension or modification of existing registrations. Here's a detailed breakdown:

### Validity Requirements

1. **Registration Validity Period**

   - The NMPA registration for medical devices typically has a validity period of **5 years**. After this period, the registration must be renewed to continue marketing the device in China.

2. **Compliance with Standards**

   - The device must continuously comply with applicable Chinese regulations, standards, and any changes to the relevant laws that may occur during the registration period.

3. **Post-Market Surveillance**

   - Manufacturers should maintain ongoing post-market surveillance activities to monitor the safety and effectiveness of the device. This includes reporting any adverse events or incidents to the NMPA.

4. **Maintain Quality Management System (QMS)**

   - The manufacturer must maintain a compliant QMS (often ISO 13485) throughout the validity of the registration, ensuring quality control measures are consistently applied.

### Extension Conditions

1. **Renewal Application**

   - Manufacturers must submit a **renewal application** to the NMPA before the expiration of the current registration. It’s advisable to start this process at least **3 to 6 months** prior to the expiration date.

2. **Documentation Submission**

   - A complete set of updated documentation must be submitted, demonstrating that the device continues to meet safety and efficacy standards. This may include:

     - Updated technical and clinical data (if applicable)

     - Evidence of post-market performance

     - Proof of compliance with any new regulations or standards that have come into effect since the last registration.

3. **Changes to the Device or Manufacturing Process**

   - If there are changes to the device design, manufacturing processes, or intended use, a separate **application for modification** may be required instead of a simple renewal. This also applies to significant changes in materials or technology related to the device.

4. **Clinical Data Requirements**

   - For significant modifications, NMPA may require new clinical data or studies to demonstrate that the device's safety and performance are not adversely affected by the changes.

5. **Fees**

   - Payment of any associated fees for the registration renewal process is typically required.

### Special Considerations

- **Adverse Events Reporting**: If any significant adverse events or recalls have occurred during the validity period, this must be reported to the NMPA when applying for renewal. The NMPA may consider this information during their review.

- **On-Site Inspections**: The NMPA may conduct on-site inspections again if there are substantial changes in manufacturing or if they determine it necessary based on compliance history.

- **Local Regulations**: Always check for any updates or changes in local regulations that might affect the registration validity and renewal process, as China’s regulations can evolve.

### Conclusion

Manufacturers must pay close attention to the validity and renewal conditions laid out by the NMPA to ensure uninterrupted market access for their medical devices in China. Engaging with regulatory consultants familiar with the landscape can also be beneficial. If you have any specific situations or further questions, feel free to ask!

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