The assessment and review requirements for the background of medical device enterprises seeking NMPA (National Medical Products Administration) certification in China involve several key components:

1. Company Registration and Legal Status

• Business License: Enterprises must provide proof of valid business registration in China. This includes a business license and relevant legal documents.
• Ownership Structure: Disclosure of ownership and management structure, including information about shareholders and key management personnel.

2. Quality Management System (QMS)

• ISO Certification: Companies typically need to demonstrate compliance with ISO 13485, which outlines requirements for a quality management system specific to medical devices.
• Internal Audits: Evidence of internal audits and management reviews must be submitted, indicating the effectiveness of the QMS.

3. Technical Capabilities

• Personnel Qualifications: Documentation of the qualifications and training of key personnel involved in design, manufacturing, and quality control.
• Facility Inspection: The manufacturing facility must be inspected to ensure it meets regulatory requirements. This includes equipment calibration, maintenance records, and cleanliness protocols.

4. Product Documentation

• Technical Files: Companies must prepare detailed technical files for the medical devices, including design specifications, manufacturing processes, and safety and efficacy data.
• Preclinical and Clinical Data: Depending on the device classification, preclinical and clinical trial data may be required to demonstrate safety and effectiveness.

5. Regulatory Compliance History

• Previous Registrations: Information about past registrations and compliance history with NMPA and other regulatory bodies.
• Adverse Event Reports: Any history of product recalls, adverse events, or non-compliance issues must be disclosed.

6. Audit by NMPA

• On-site Inspection: NMPA conducts on-site inspections of the manufacturing facilities and quality control processes to verify compliance with regulatory requirements.
• Documentation Review: A thorough review of all submitted documentation, including quality manuals, standard operating procedures (SOPs), and training records.

7. Post-Market Surveillance Plans

• Surveillance Strategy: Enterprises must outline their post-market surveillance strategy to monitor product performance after commercialization, including plans for reporting adverse events and maintaining product quality.

Conclusion

Meeting these assessment and review requirements is crucial for obtaining NMPA certification. The process aims to ensure that medical devices are safe, effective, and manufactured in compliance with applicable standards. Preparing comprehensive documentation and maintaining a robust quality management system are essential for a successful certification process.

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