Yes, China's NMPA (National Medical Products Administration) registration process for medical devices may require a face-to-face on-site inspection under certain conditions. However, this is generally not a blanket requirement for all medical devices, and it depends on several factors, such as the classification of the device, the manufacturer's location, and the type of device being registered.

Here’s an overview of when and why NMPA might require an on-site inspection:

1. When On-Site Inspections are Required

A. High-Risk Devices (Class III)

For Class III medical devices, which are high-risk devices (e.g., pacemakers, infusion pumps, implants, etc.), NMPA is more likely to require an on-site inspection of the manufacturing facility. This is because:

• These devices pose a higher risk to patients and require a more stringent review process.
• NMPA needs to ensure that the manufacturing processes, facilities, and quality control systems meet the required safety and regulatory standards.

The inspection may be conducted by NMPA officials or authorized third-party inspection agencies. The process helps to verify that the manufacturer is adhering to Good Manufacturing Practices (GMP) and other relevant standards.

B. Foreign Manufacturers

For foreign manufacturers, NMPA requires an on-site inspection of the manufacturing facility located outside China for Class II and III medical devices. This is a critical part of the registration process, as NMPA needs to assess the quality control systems, manufacturing practices, and compliance with Chinese regulations.

• If the device is being imported into China, NMPA or an authorized third-party body may carry out an inspection of the foreign manufacturing facility to confirm compliance with China's GMP regulations and ensure the facility meets the necessary quality standards.
• For Class I devices, an on-site inspection is typically not required for foreign manufacturers, as the registration process is less stringent.

C. High-Risk Medical Devices with Complex Manufacturing Processes

Even for some Class II devices (moderate risk), on-site inspections may be required if the device has complex manufacturing processes or involves higher potential risks (e.g., medical devices that are critical to patient health, like heart valves or certain diagnostic equipment).

2. On-Site Inspection for Quality Management Systems (QMS)

Manufacturers of Class II and III medical devices must demonstrate compliance with ISO 13485 and GMP standards. An on-site audit or inspection may be required to verify that the Quality Management System (QMS) is in place and effectively implemented at the manufacturing facility.

• ISO 13485 certification is a critical part of the registration process, and NMPA may need to verify that the quality management system at the manufacturing site complies with international standards.
• If the manufacturer is a foreign entity, NMPA may also conduct a remote audit if they accept international certifications (e.g., from the EU or the US) in lieu of a full on-site inspection.

3. Specific Conditions for On-Site Inspections

A. Domestic Manufacturers

For domestic manufacturers (i.e., those located in China), NMPA generally conducts on-site inspections of Class III devices, especially if the device is novel or has high risk. For Class I and Class II devices, the inspection may not be mandatory unless there is a specific concern about the manufacturing process or product quality.

B. Special Cases

• Devices with a Novel Technology: If the device uses new or complex technology, such as innovative software or a new type of bio-material, NMPA might request an inspection to verify the safety and compliance of the manufacturing processes.
• History of Non-Compliance: If the manufacturer has a history of regulatory issues or non-compliance in previous submissions, NMPA may insist on an on-site inspection to ensure that corrective actions have been taken.

4. Remote Inspections (During COVID-19 and Beyond)

Due to the COVID-19 pandemic, NMPA, like many regulatory authorities around the world, temporarily adapted its inspection procedures. For some foreign manufacturers, NMPA allowed remote inspections or video audits as an alternative to physical on-site inspections.

• In certain cases, remote inspections may still be allowed for specific types of medical devices or when NMPA deems it appropriate, especially for low-risk devices (Class I) or devices with established international certifications.
• However, these remote inspections are generally not a permanent alternative and may not be acceptable for higher-risk devices (Class II and III).

5. Process of On-Site Inspections

• Application Submission: Once the registration application is submitted, NMPA may review the documents and assess whether an on-site inspection is necessary.
• Inspection Notification: If an on-site inspection is required, NMPA will notify the manufacturer and schedule the inspection. This process may involve submitting additional documentation, such as detailed manufacturing processes, GMP certifications, and records of product testing.
• Inspection: The on-site inspection typically involves verifying the quality control and manufacturing processes, reviewing documentation (e.g., product testing reports, batch records, QMS compliance), and ensuring that the facility meets all Chinese regulations.
• Post-Inspection: Following the inspection, NMPA may issue a report or require corrective actions if any discrepancies or issues are found. If the inspection is successful, the manufacturer can proceed with the next steps in the registration process.

6. Impact of On-Site Inspections on the Registration Process

On-site inspections can significantly affect the timeline for device registration:

• Additional Time: On-site inspections can add time to the registration process, especially for foreign manufacturers who need to arrange for inspections at their facilities abroad.
• Delays: If issues are found during the inspection (e.g., non-compliance with quality standards), this can lead to delays or requests for corrective actions before the registration can be approved.

Summary

• On-site inspections are generally required for Class II and III medical devices (moderate to high-risk devices), especially when the manufacturing facility is located outside of China.
• Foreign manufacturers of high-risk devices are more likely to face an on-site inspection to verify compliance with Chinese Good Manufacturing Practices (GMP).
• Domestic manufacturers may also face inspections for high-risk devices but less frequently for Class I devices.
• The COVID-19 pandemic has led to more flexible inspection options, such as remote inspections, but this is subject to change as the global situation evolves.

Manufacturers should be prepared for the possibility of an on-site inspection, especially for high-risk devices or if the device involves novel technologies, and ensure that they meet the relevant Chinese regulatory standards for manufacturing, quality control, and documentation.