Yes, the on-site review for NMPA (National Medical Products Administration) registration of medical devices in China does exist, although it is not required for every application. The on-site inspection or audit typically occurs in certain circumstances, such as when the NMPA deems it necessary to assess the manufacturer's compliance with local regulations or when the medical device is considered high-risk.

Here are the main points about the on-site review process:

1. When is an On-Site Review Required?

• High-Risk Devices: The NMPA may require an on-site inspection for higher-risk medical devices, such as Class III devices or those with complicated manufacturing processes.
• New Manufacturers: If the manufacturer has not previously registered products with the NMPA, or if the manufacturing facility has not been inspected, an on-site review may be requested.
• Compliance Checks: The NMPA may also schedule on-site visits to verify compliance with the Good Manufacturing Practices (GMP) or to assess the quality control systems and production standards at the manufacturing facility.
• Special Circumstances: In some cases, the NMPA may perform an on-site review as part of a random audit or if there are concerns about the submitted documentation or product quality.

2. What Happens During the On-Site Review?

• Facility Inspection: NMPA officials will visit the manufacturing site to verify that it adheres to the required standards, such as GMP compliance, safety measures, and product consistency.
• Document Review: The NMPA will also review the manufacturer’s quality management system, production processes, testing protocols, and traceability practices.
• Interviews and Discussions: Officials may interview key staff members, including quality assurance managers and technical experts, to ensure that processes are well-understood and followed correctly.

3. How Long Does the On-Site Review Take?

The length of the on-site review varies depending on the complexity of the product and the size of the manufacturing facility. It could take anywhere from a few days to a week or more.

4. Impact on the Registration Process

• Outcome: If the on-site review is successful and the NMPA is satisfied with the findings, it will not cause significant delays in the registration process. However, if there are issues, the NMPA may request corrective actions before proceeding.
• Follow-Up: Manufacturers may need to address any non-compliance or quality control issues identified during the visit, which could lead to further evaluations or documentation submission.

5. Preparation for an On-Site Review

• GMP Compliance: Ensure that the manufacturing facility is compliant with China’s GMP standards. This is a key factor for the success of the on-site review.
• Documentation: Have all necessary documents and evidence ready, such as quality management system (QMS) records, manufacturing and testing procedures, and training materials.
• Training: It is advisable to train staff on the procedures they may be asked about, as a failure to demonstrate knowledge of good practices can result in delays or rejection.

6. Virtual Inspections (Post-COVID)

During the COVID-19 pandemic, the NMPA introduced some flexibility, allowing virtual or remote inspections in some cases. While on-site visits have resumed in many situations, it is possible that some inspections may still be conducted virtually, especially if the manufacturing site is outside China.

In summary, an on-site review is part of the NMPA medical device registration process, but its necessity depends on the type of device, manufacturer history, and risk level. Being prepared for this eventuality can help ensure a smoother process.