An on-site review (also referred to as an on-site inspection or manufacturing facility inspection) is often required as part of the NMPA (National Medical Products Administration) registration process for medical devices in China, particularly for foreign manufacturers and for higher-risk devices (Class II and III). However, whether an on-site review is mandatory or necessary depends on several factors, including the type of device, the manufacturer's location, and the registration process itself.

Key Considerations for On-Site Review in NMPA Registration

1. Type of Device (Risk Classification)

• Class I Devices: Generally, Class I medical devices (low-risk devices) may not require an on-site review. These devices are usually subject to less stringent regulatory requirements, and their registration process often involves a documentary review by NMPA rather than an inspection of the manufacturing site.

• Class II and Class III Devices: For Class II and Class III devices (medium and high-risk), especially those that are more complex, involve new technologies, or are designed for critical healthcare applications, an on-site review is more likely to be required. This inspection ensures that the manufacturing facility adheres to the necessary Good Manufacturing Practices (GMP) and complies with safety, quality, and regulatory requirements.

  • Class II devices may require sampling inspections or spot checks, but an on-site inspection is often part of the process.
  • Class III devices, which are the highest risk, are subject to more rigorous regulatory scrutiny, and NMPA is more likely to perform an on-site review as part of the approval process.

2. Manufacturer’s Location

• Foreign Manufacturers: If the manufacturer is located outside of China, an on-site review by NMPA is typically required. This review is to ensure that the manufacturing facility meets Chinese GMP standards and complies with relevant safety, quality control, and regulatory procedures. This is particularly common for foreign manufacturers seeking to import medical devices into China.

  • The Foreign Manufacturer must appoint a local authorized representative (LAR) in China to facilitate communication and the registration process.
  • The on-site review is conducted by NMPA officials, who may inspect the facility's quality management system, manufacturing processes, and compliance with regulatory standards.

• Domestic Manufacturers: For domestic manufacturers (based in China), an on-site inspection may still be required for Class II and Class III devices. However, the process may be less stringent or easier to facilitate compared to foreign manufacturers, as they are subject to regular NMPA inspections as part of the general regulatory framework.

3. NMPA Registration Process

• Product Dossier Submission: For most devices, the registration application starts with the submission of a detailed product dossier to NMPA. This dossier includes technical documents, test reports, labeling information, and other compliance materials.

• On-Site Review Process: If NMPA decides that an on-site review is necessary, the manufacturer will be notified. The on-site inspection typically includes the following:

  • Facility inspection: An NMPA inspector will visit the manufacturing site to evaluate the company's quality control systems, production processes, and compliance with Chinese regulations.
  • GMP Compliance: The manufacturer must demonstrate compliance with Good Manufacturing Practices (GMP) in the production of medical devices, which include quality management systems, proper documentation, and adherence to standards for equipment, personnel, and testing procedures.
  • Document Review: Inspectors will also review critical technical documents, including design controls, production records, test reports, and post-market surveillance plans.

• Timing of Inspection: The timing of the on-site inspection may vary. In some cases, the inspection may happen after the initial submission and review of documentation, while in other cases, it may occur as part of a more comprehensive evaluation before NMPA grants approval for market entry.

4. Impact of On-Site Reviews

• Foreign Manufacturers: For foreign manufacturers, the on-site review is often seen as a necessary step to prove that the device is produced in compliance with Chinese standards and to establish that the foreign manufacturer adheres to proper regulatory practices. This is a critical step for manufacturers who wish to export their medical devices to China.

• Domestic Manufacturers: Domestic manufacturers may not be subject to such rigorous inspections unless their devices are classified as higher-risk. However, NMPA may still conduct periodic inspections or audits to ensure ongoing compliance with regulatory requirements.

5. Exceptions or Exemptions

• In certain situations, some lower-risk medical devices or devices with established international certifications (e.g., CE Mark, FDA approval) might be granted exceptions or exemptions from the on-site inspection requirement. In these cases, NMPA may accept equivalency certifications and regulatory documents, though this is more common for devices that are already approved in other major markets and are deemed to meet international safety and quality standards.
  • For example, devices already certified with FDA or CE may not need a full NMPA inspection but may still undergo a streamlined review process.

Summary of On-Site Review Necessity for NMPA Registration

• Required for Foreign Manufacturers: Yes, an on-site review is almost always necessary for foreign manufacturers applying for NMPA registration, especially for Class II and Class III medical devices. This is to ensure that the manufacturer's facility meets Chinese regulatory and GMP standards.

• Required for High-Risk Devices: Yes, an on-site review is typically required for higher-risk devices (Class II and III) to confirm that manufacturing practices and quality control systems meet Chinese safety and quality standards.

• Not Always Required for Low-Risk Devices: For Class I devices (low-risk), NMPA may not require an on-site inspection. These devices are typically evaluated based on submitted technical documentation without the need for an on-site review.

• Possible Exemptions: Devices that already have strong international approvals (e.g., CE or FDA) may face a more streamlined review process and, in some cases, may avoid the need for an on-site inspection. However, the manufacturer must still comply with relevant Chinese regulations.

In conclusion, on-site reviews are generally necessary for high-risk medical devices and foreign manufacturers as part of the NMPA certification process, but low-risk devices may not always require such inspections. Manufacturers should be prepared for the possibility of an on-site review, particularly if they are introducing more complex devices to the Chinese market.