Yes, an on-site review is sometimes necessary as part of the National Medical Products Administration (NMPA) registration process for medical devices in China, particularly for high-risk devices, new technologies, or foreign manufacturers. However, whether an on-site review is required depends on the classification of the device, the manufacturer's location, and the complexity of the product.

Here’s a detailed breakdown of when an on-site review may be necessary and under what circumstances:

1. When On-Site Review is Typically Required

An on-site review is more common for Class II (medium risk) and Class III (high risk) devices, especially when:

• New or Innovative Devices: If the medical device is new, innovative, or involves unproven technology (e.g., novel therapeutic methods or advanced software), the NMPA may want to inspect the manufacturing process and the facility to verify that it meets quality and safety standards.

• Foreign Manufacturers: If the medical device is manufactured outside of China (particularly in a foreign facility), the NMPA often conducts on-site reviews to ensure that the manufacturing plant complies with the necessary Good Manufacturing Practices (GMP) and adheres to Chinese regulatory requirements. Foreign manufacturers must appoint a Chinese Agent (local representative) to facilitate the registration process, and the NMPA may visit the manufacturing site in the country of origin.

• Complex or High-Risk Devices: Devices that are classified as Class III (the highest risk category), such as implantable devices, life-supporting devices, or devices requiring clinical trials for approval, often undergo a thorough on-site inspection. The NMPA wants to verify the manufacturer’s ability to produce the device safely and consistently, ensuring that the production process meets rigorous standards.

2. What Happens During the On-Site Review?

An on-site review typically includes the following elements:

• Facility Inspection: NMPA inspectors visit the manufacturing facility to assess the manufacturing environment, cleanliness, production processes, equipment calibration, and overall compliance with Good Manufacturing Practice (GMP).

• Review of Manufacturing Processes: Inspectors will review the quality management system (QMS) and manufacturing processes. This includes examining the documentation for product development, testing protocols, and design controls.

• Verification of Compliance with Safety and Quality Standards: The NMPA checks whether the device complies with Chinese safety and technical standards, such as GB standards (e.g., GB 9706 for medical electrical equipment) and international standards like ISO 13485 for quality management.

• Inspection of Clinical Data and Testing Protocols: For devices requiring clinical trials (especially Class III devices), the NMPA may review the clinical trial design, safety data, and trial results to ensure they meet regulatory requirements.

3. When On-Site Review May Not Be Required

In some cases, an on-site review may not be necessary, especially when:

• Class I Devices: These are lower-risk devices (e.g., basic diagnostic tools) that do not require an on-site review. These devices can often be approved based on a self-declaration by the manufacturer that they meet safety and performance standards.

• Devices Already Certified: If the manufacturer has a previous record of successful NMPA certification for similar devices, and the new device is similar in design or functionality, the NMPA may rely on documentary review rather than an on-site inspection.

• Domestic Manufacturers: For Chinese domestic manufacturers who already comply with NMPA standards and have an established relationship with the NMPA, an on-site review may not be required, as they are familiar with the country’s regulatory processes.

• Less Complex Devices: Some Class II devices with low to moderate risk may be able to bypass an on-site inspection, especially if the documentation submitted (e.g., technical files, risk analysis) provides sufficient evidence of compliance with safety and performance standards.

4. Why an On-Site Review is Necessary for Some Devices

The on-site review process is an important component of ensuring that devices meet Chinese regulatory standards. The reasons it might be required include:

• Ensuring Manufacturing Quality: NMPA wants to confirm that the manufacturer follows strict quality control procedures and consistently produces high-quality, safe medical devices. This is especially important for higher-risk devices, where safety issues could have severe consequences.

• Confirming Compliance with GMP: For foreign manufacturers, the NMPA must ensure that the manufacturer adheres to Good Manufacturing Practice (GMP). This is especially true for Class III devices (such as surgical implants or life-support equipment) where the production process needs to meet the highest standards.

• Verifying Clinical Data: In some cases, the NMPA might request to review the clinical trial sites or protocols to ensure they meet Chinese clinical and ethical standards, especially for high-risk devices.

• Ensuring Post-Market Compliance: By conducting an on-site inspection, NMPA can assess the manufacturer's post-market surveillance capabilities, ensuring that they can track the device’s performance once it reaches the market.

5. Steps to Prepare for an On-Site Review

If an on-site review is required for your medical device registration, manufacturers should be well-prepared by:

• Ensuring Compliance with GMP: Ensure that the manufacturing facility complies with the relevant Good Manufacturing Practice (GMP) standards. This includes documentation, equipment calibration, and adherence to all applicable safety and environmental regulations.

• Organizing Technical and Clinical Data: Organize and make available all technical documents, clinical trial data, and test reports. Be ready to show evidence of biocompatibility, electrical safety, mechanical safety, and any other safety or performance-related tests required by NMPA.

• Documenting Quality Management Systems: Demonstrate that the company has a certified Quality Management System (QMS), such as compliance with ISO 13485 or equivalent.

• Having a Chinese Representative: Work with a Chinese agent or local representative who can help coordinate and facilitate the on-site inspection and handle any additional documentation requirements.

6. Alternatives to On-Site Review

In some cases, the NMPA may accept documentary evidence in place of an on-site inspection. This can include:

• Third-party Audits: NMPA may accept audits or inspections conducted by recognized third-party certification bodies, particularly if the manufacturer already holds ISO 13485 certification.

• Remote Assessments: In certain circumstances, especially during times when international travel is restricted, the NMPA may conduct virtual inspections or accept remote documentation submissions to assess compliance.

Conclusion

An on-site review for NMPA registration is often necessary, especially for Class II and Class III devices, new technologies, or foreign manufacturers. The review ensures that the manufacturer complies with Good Manufacturing Practices (GMP), adheres to relevant safety standards, and can reliably produce safe and effective medical devices. While on-site inspections are common for high-risk devices, certain low-risk devices or established manufacturers may avoid them, relying on documentary reviews instead. Manufacturers should be prepared for the on-site review process by ensuring robust quality control and complete documentation.