Determine the classification of your EEG machine according to Chinese medical device regulations (Class I, II, or III). This classification will determine the specific requirements and pathway for certification.

Determine the classification of your EEG machine according to Chinese medical device regulations (Class I, II, or III). This classification will dictate the specific requirements and pathways for certification.

Keep your NMPA Registration Certificate and related documents updated and accessible for regulatory inspections and audits.

Detailed description of the EEG machine, including its intended use, indications, and technical specifications (e.g., model numbers, dimensions, weight).

Classification: Determine the classification of your EEG machine according to the Chinese medical device classification rules (Class I, II, or III). This classification will dictate the specific requirements and procedures for certification.

Preparation of Documentation: Gather all necessary technical documentation, including detailed specifications, design drawings, and manufacturing processes. This should include information on the EEG machine's safety, performance, and efficacy.

510(k) Submission: As of 2024, the FDA's standard user fee for a 510(k) submission is approximately $12,922 for FY 2024. Small businesses (defined by FDA criteria) may qualify for reduced fees.

For FDA certification (FDA clearance or approval) of a medical device, the concept of a "technical file" is not explicitly used in the same way as in European regulations (e.g., for CE marking). However, the FDA does require specific documentation and technical information to support the application for clearance or approval.