In China, the National Medical Products Administration (NMPA) oversees the certification of medical devices, and independent auditing bodies play a crucial role in evaluating the technical specifications of these devices. Here’s an overview of how the evaluation process typically works:

1. Application Submission

The process begins when a manufacturer submits an application to the NMPA along with all necessary documents, including technical specifications, product samples, and test reports. These documents must meet the specific regulatory requirements established by the NMPA.

2. Documentation Review

Independent auditing bodies first conduct a thorough review of the submitted documentation. This includes:

• Technical Specifications: Evaluating the design, materials, intended use, and performance characteristics of the medical device.
• Manufacturing Processes: Reviewing the manufacturing process and quality control measures to ensure compliance with Good Manufacturing Practices (GMP).
• Risk Management: Assessing the risk management file according to ISO 14971, which details how risks associated with the device have been identified, evaluated, and mitigated.

3. Testing and Evaluation

After the documentation review, the auditing body may require:

• Laboratory Testing: Conducting tests to verify that the device meets its intended specifications. This may involve performance tests, biocompatibility assessments, and electrical safety evaluations, depending on the device type.
• Clinical Evaluation: For certain devices, particularly those classified as higher risk, a clinical evaluation may be necessary. This involves reviewing clinical data to assess the safety and efficacy of the device in human subjects.

4. On-Site Inspection

If the device passes the initial documentation and testing phases, the auditing body may perform an on-site inspection of the manufacturing facility. This inspection assesses:

• Quality Management System (QMS): Evaluating the manufacturer’s QMS to ensure it complies with ISO 13485 and other relevant standards.
• Production Processes: Observing production processes and ensuring that they are in line with the documented procedures.

5. Evaluation Report

Following the review, testing, and inspection, the auditing body compiles an evaluation report. This report summarizes:

• Compliance with regulatory requirements.
• Findings from the documentation review, testing, and on-site inspection.
• Recommendations or required corrective actions if any deficiencies are identified.

6. Decision Making

Based on the evaluation report, the NMPA makes a decision regarding the certification. If the device meets all requirements, the NMPA grants certification, allowing the manufacturer to market the device in China.

7. Post-Market Surveillance

Once certified, manufacturers must comply with post-market surveillance requirements, which include reporting adverse events and conducting periodic audits to ensure ongoing compliance with the regulations.

Conclusion

The evaluation process by independent auditing bodies in China’s NMPA certification is comprehensive and involves multiple stages, including documentation review, testing, on-site inspections, and reporting. This rigorous assessment helps ensure that medical devices are safe, effective, and compliant with Chinese regulations before they reach the market.

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