To handle NMPA certification for pulse oximeters, you'll need to follow a structured approach:

1. Preparation of Documentation: Gather and prepare all necessary technical documents, including device specifications, test reports, and manufacturing processes.

2. Clinical Evaluation: Conduct a clinical evaluation to demonstrate the safety and effectiveness of the pulse oximeter according to NMPA requirements.

3. Quality Management System: Implement a quality management system (QMS) that complies with relevant NMPA regulations, such as GB/T 19001-2016.

4. Testing and Compliance: Ensure the pulse oximeter meets applicable standards and regulations, such as GB 9706.1-2007 for medical electrical equipment.

5. Application Submission: Prepare and submit your application through the NMPA's online portal, including all required documentation and fees.

6. Review and Approval: Await the NMPA's review of your application. This process typically involves a thorough evaluation of your submission and may include additional clarifications or requests for information.

7. Post-Market Surveillance: After obtaining certification, maintain compliance through post-market surveillance activities, including reporting adverse events and updating registrations as required.

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