On-site inspections are not universally required for all NMPA-registered medical devices in China, but they do play a crucial role in the certification process, particularly for higher-risk devices.

When On-Site Inspections Are Required

1. Class II and III Devices:

   • Class II and III medical devices typically require an on-site inspection of the manufacturing facility. This inspection assesses the quality management system (QMS), production processes, and compliance with applicable standards.
   • The NMPA will conduct these inspections to verify that the manufacturer adheres to ISO 13485 standards and other relevant regulations.

2. First-Time Applicants:

   • For manufacturers who are applying for NMPA registration for the first time, an on-site inspection is often mandatory. This ensures that the facilities and processes are compliant from the outset.

3. Post-Market Surveillance:

   • After initial registration, the NMPA may also conduct periodic inspections as part of post-market surveillance to ensure ongoing compliance with regulatory standards.

When On-Site Inspections May Be Waived

1. Class I Devices:

   • Class I medical devices, which are considered low risk, generally do not require an on-site inspection. These devices can often be registered through a filing process rather than a full approval process.

2. Existing Manufacturing Sites:

   • If the manufacturer has previously been inspected and certified under the NMPA and is applying for additional products from the same facility, an on-site inspection may be waived depending on the circumstances.

3. Foreign Manufacturers:

   • For foreign manufacturers, the NMPA may accept third-party audit reports or certifications from recognized international standards bodies as part of the registration process. However, this is case-dependent and not guaranteed.

Conclusion

In summary, while on-site inspections are a key component of the NMPA registration process for many medical devices, especially higher-risk categories, they are not universally required for all devices. Manufacturers should be prepared for inspections if they are applying for Class II or III device registrations and ensure that their facilities comply with relevant quality standards. Consulting with regulatory experts can provide clarity on specific requirements based on the product category and manufacturer status.