Yes, medical devices typically need to undergo an on-site inspection as part of the registration process with the National Medical Products Administration (NMPA) in China, although this requirement can vary depending on the classification and type of device. Here’s a breakdown of when and why on-site inspections are necessary:

1. Class II and Class III Medical Devices

• Class II: These devices may require an on-site inspection if there are concerns about the quality control processes or the manufacturing conditions.
• Class III: Most Class III devices (higher-risk devices) will generally undergo a more rigorous evaluation, including on-site inspection. These inspections may be part of the technical review process to verify the manufacturer’s facilities, quality management systems, and production practices.

2. When is On-Site Inspection Required?

• New Manufacturers: If the manufacturer is not already registered with NMPA, or if it’s a new production facility, an inspection is usually required to verify that the facility meets Chinese regulatory standards.
• Foreign Manufacturers: If the device is manufactured outside China, NMPA will likely arrange for an inspection of the production facility, even if the manufacturer has previously registered other devices. This process ensures that the overseas manufacturing facility complies with Chinese regulations and quality standards.
• Device Complexity: For more complex or higher-risk devices (Class III), there is a higher likelihood that an on-site inspection will be needed. For simpler devices (Class I), the requirement for an inspection is less common.

3. Inspection Process

• The inspection typically covers the manufacturer’s quality management system, production processes, testing facilities, and documentation.
• The NMPA inspectors will verify whether the manufacturer's practices align with the Good Manufacturing Practice (GMP) standards required for medical devices.
• The manufacturer must also provide detailed documentation to support the claims made in the registration application, including product design, testing data, and quality control procedures.

4. For Imported Medical Devices

• If an imported medical device is being registered, the NMPA may require the manufacturer to undergo an on-site inspection to verify the quality management system and manufacturing processes.
• The inspection may be conducted by NMPA’s own inspectors or a third-party agency accredited by NMPA.

5. Remote Inspections

• In certain circumstances, particularly for overseas manufacturers, remote inspections (e.g., virtual inspections via video conferencing) have been conducted, especially since the COVID-19 pandemic. However, this practice is typically used for specific situations and is not a universal alternative.

Conclusion:

On-site inspections are an integral part of the NMPA registration process, especially for higher-risk devices and foreign manufacturers. It is essential for manufacturers to be prepared for this inspection by ensuring that their facilities and quality management systems meet Chinese regulatory requirements.

For specific information on your device’s classification or if you need to schedule an inspection, consulting with a local regulatory expert or contacting NMPA directly can help clarify the exact steps and requirements.