The registration and review process for NMPA Class I medical devices in China typically involves the following steps:

1. Pre-registration Preparation:

   • Determine Classification: Confirm that the device is classified as Class I. Class I devices are considered low-risk and usually include items such as certain non-invasive devices.
   • Prepare Documentation: Gather all necessary documentation, including product descriptions, technical specifications, labeling, and proof of compliance with quality management standards (if applicable).

2. Submission of Application:

   • Submit Application: Submit the registration application through the NMPA’s online portal or in person, depending on the specific requirements at the time.
   • Documentation: Include all required documents, such as the product’s technical dossier, evidence of manufacturing quality, and any other relevant materials.

3. Document Review:

   • Initial Review: NMPA reviews the submitted documents to ensure they are complete and comply with regulatory requirements.
   • Additional Information: NMPA may request additional information or clarifications if needed.

4. Approval and Registration:

   • Approval Decision: If the NMPA is satisfied with the documentation, they will issue a registration certificate for the Class I medical device.
   • Registration Certificate: The registration certificate is issued and allows the device to be marketed and sold in China.

5. Post-registration:

   • Quality Management System: While Class I devices typically do not require on-site inspections, manufacturers should still maintain a quality management system as per NMPA guidelines.
   • Periodic Updates: Manufacturers may need to update their registration periodically or in case of any significant changes to the device or its manufacturing process.

This process is generally less stringent compared to higher-risk device classes, which may involve more detailed reviews and on-site inspections.