Yes, NMPA (National Medical Products Administration) registration does require periodic reviews, though the specifics depend on the type of device and its classification. These reviews are designed to ensure ongoing compliance with regulatory requirements and to monitor the device's performance in the market. Below is a breakdown of the key aspects related to periodic review for NMPA-registered medical devices:

1. Renewal of Registration

• Registration Validity: NMPA certificates are generally valid for five years from the date of issuance. After this period, the manufacturer must apply for renewal to continue marketing the device in China.
• Renewal Process: The renewal process involves submitting updated documentation, including:
  • Post-market surveillance data, such as adverse event reports, product performance updates, and information on any product recalls (if applicable).
  • Updated manufacturing practices and quality control processes, demonstrating continued compliance with regulatory requirements.
  • Inspection reports if any significant changes have been made to the manufacturing process or facility.
• Renewal Application: The renewal application is generally less extensive than the original registration, but it still requires careful attention to detail. The manufacturer must submit the application at least 6 months before the expiration of the current registration to allow enough time for NMPA to process the renewal.

2. Post-Market Surveillance (PMS) and Reporting

• Ongoing Monitoring: NMPA places significant emphasis on post-market surveillance, which involves monitoring the safety and effectiveness of a device after it has been released onto the market. Manufacturers are required to establish a system to track and report adverse events, defects, and performance issues.
  • Adverse Event Reporting: Any adverse events related to the device, such as malfunctions, safety issues, or injury, must be reported to NMPA in a timely manner.
  • Periodic Safety Updates: Manufacturers may need to submit periodic updates to NMPA that include safety data, risk management findings, and any corrective or preventive actions taken (such as recalls or modifications to the device).
• Compliance with PMS Requirements: NMPA often requires manufacturers to conduct post-market clinical follow-up (PMCF) or other forms of post-market studies to confirm the long-term safety and efficacy of the device, especially for high-risk devices (Class II and Class III).

3. Changes to the Product or Manufacturing Process

• Significant Changes: If there are any significant changes to the medical device (such as a change in design, materials, or intended use), or to the manufacturing process or facility, these must be reported to NMPA.
  • For minor changes, manufacturers may only need to update their technical documentation.
  • For major changes (e.g., changes in device classification or a modification to the manufacturing site), the manufacturer may need to submit a new registration application or undergo a new review and approval process.

4. Inspection and Audits

• Facility Inspections: In some cases, NMPA may conduct inspections or audits of the manufacturing facility to ensure that it continues to comply with Good Manufacturing Practices (GMP), especially for Class II and Class III devices.
• Unannounced Audits: NMPA may also conduct unannounced inspections as part of its post-market surveillance activities to ensure ongoing compliance with the regulations.

5. Updates to Regulations and Standards

• Regulatory Changes: As regulations and standards evolve, manufacturers are expected to stay informed of any changes that may impact the ongoing compliance of their device. For instance, new GB standards (Chinese national standards) or YY standards (medical device industry standards) may be introduced, and manufacturers will need to ensure that their products remain compliant with these updated standards.

• Regulatory Updates: Manufacturers must ensure that their devices continue to meet NMPA’s evolving safety, efficacy, and performance standards. Failure to do so may result in the device being removed from the market.

6. Periodic Review of Device Performance

• Annual Reporting (for high-risk devices): Manufacturers of higher-risk devices (Class II and Class III) may be required to submit annual reports to NMPA, summarizing device performance, safety data, and any incidents or changes related to the product.
• Product Recalls and Corrective Actions: If a device poses a significant risk to patient safety, NMPA may require the manufacturer to implement corrective actions, which could include conducting a product recall or issuing safety notifications to users.

7. Other Periodic Reviews

• Clinical Data Review: For devices that require clinical data as part of their registration (especially Class III devices), the clinical data might be subject to periodic review to verify long-term safety and efficacy. This is particularly true if new risks emerge after the product has been placed on the market.

Summary of Key Points on Periodic Review:

• Renewal Every 5 Years: Manufacturers must apply for a renewal of their NMPA registration every five years. The renewal involves submitting updated documentation, including post-market data and safety information.
• Post-Market Surveillance: Manufacturers must actively monitor the device's performance in the market and report any adverse events or safety issues to NMPA. This also includes reporting on product recalls and corrective actions.
• Changes to the Device or Facility: Significant changes to the device or manufacturing process may require a new registration or approval process.
• Regulatory Updates: Manufacturers need to stay updated on regulatory changes and ensure their devices comply with evolving standards.
• Inspections and Audits: Periodic inspections of the manufacturing facility may be required to ensure continued compliance with regulatory standards.

By ensuring compliance with these periodic review requirements, manufacturers can maintain NMPA approval for their medical devices, ensure their devices' safety and efficacy, and continue to market them in China.