Yes, NMPA (National Medical Products Administration) certification does require periodic evaluation for certain medical devices. The NMPA, which is the regulatory authority for medical devices in China, mandates ongoing oversight to ensure that devices continue to meet safety, quality, and performance standards even after they have been certified.

Here are the key aspects of periodic evaluation under NMPA certification:

1. Post-Market Surveillance (PMS)

• Monitoring: Once a medical device is placed on the market, manufacturers must continue to monitor its safety and effectiveness. This includes collecting and analyzing data on adverse events, complaints, and device performance in real-world settings.
• Reporting: Manufacturers are required to report any significant adverse events or defects that occur after the device has been marketed to the NMPA. In certain cases, the NMPA may require the manufacturer to take corrective actions, such as issuing a recall or updating the product’s labeling.

2. Renewal of NMPA Registration

• NMPA registration for medical devices is typically valid for five years. After this period, manufacturers must apply for renewal of their certification.
• The renewal process requires the submission of updated technical documentation and supporting evidence that the device continues to meet the relevant safety and performance standards. This includes providing post-market data and addressing any regulatory changes that may have occurred since the last certification.

3. Periodic Inspections and Audits

• The NMPA may conduct periodic inspections or audits of manufacturing facilities, especially for high-risk medical devices. These inspections verify that the manufacturer continues to comply with Good Manufacturing Practice (GMP) requirements.
• If any issues are discovered during these inspections, the NMPA may take corrective actions, including suspension of manufacturing or sales approval.

4. Changes to the Device or Manufacturing Process

• If there are any significant changes to the device, such as modifications to its design, intended use, or manufacturing process, the manufacturer must notify the NMPA. Depending on the nature of the change, the device may require a reassessment or new approval.
• Clinical trials may also be necessary if the changes impact the safety or performance of the device.

5. Risk Management

• Manufacturers must maintain a robust risk management system that is updated periodically. This system includes ongoing risk assessments, identification of new hazards, and actions to mitigate those risks. The results of these assessments are to be documented and made available to regulatory authorities if required.

6. Changes in Regulatory Requirements

• NMPA regulations and standards are subject to updates and changes. Manufacturers must ensure that their devices comply with any new or revised requirements. For example, there might be updates to standards, labeling requirements, or the need for additional testing.

7. Annual Reports (For Certain Devices)

• In some cases, manufacturers are required to submit annual reports to the NMPA detailing their post-market surveillance activities, quality control measures, and other relevant information regarding the device’s performance.

8. Special Evaluations for High-Risk Devices

• Medical devices classified as high-risk (Class III) may be subject to more frequent and detailed evaluations. These devices may require more frequent reporting, re-evaluations, and inspections to ensure they continue to meet stringent safety and performance requirements.

Conclusion:

While NMPA certification ensures that a medical device meets regulatory standards at the time of approval, periodic evaluation is an essential part of the process to maintain ongoing compliance. Manufacturers must adhere to post-market surveillance, renew certification every five years, notify the NMPA of significant changes, and ensure that the device continues to meet safety and performance standards throughout its lifecycle.