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Medical Device Companies Annual Self-Inspection Report Due March 31

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All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 739 “Medical Device Supervision and Management Regulations”.

“Guideline for Annual Self-Inspection Report on Medical Device Quality Management System” published in March 2022 includes templates for self-inspection reports with specific content and instructions for documents compilation.

The guideline also specifies that the content of the self-inspection report for each fiscal year should cover statistical data from January 1 to December 31 of that year. The report is required to be submitted to NMPA by March 31 of the following year.

For our recorded webinar on “PMS Key Updates – Enhanced Requirements of Post Market Surveillance Per Order 739”, please click HERE

Self-Report Contents

1. Overview:

(a) Basic Information on Production Activities:

  • Include basic information about the registrant, record holder, and contracted manufacturing entities.
  • Provide details such as names, addresses, production addresses, and production licenses (or record numbers).
  • Include information on medical device product registration or record numbers, along with production details (including commissioned and contracted production).
  • Specify the status of approved innovative products, prioritized approval products, and conditionally approved products.

(b) Basic Information on Commissioned and Contracted Production:

  • Outline details of commissioned and contracted production for medical devices already approved for market release.
  • Include information on commissioned products, basic information about both the commissioning and contracted parties, quality agreements for commissioned production, and quality management for commissioned products.

2. Annual Significant Changes:

(a) Product Design Changes:

  • Address design changes related to product safety, performance, and intended use.
  • Report on changes completed through review, validation, and/or confirmation.
  • Submit annual product registration (or record) change details, including renewal situations.

(b) Changes in Production and Inspection Areas, and Production and Inspection Equipment:

  • Describe changes in the locations and layouts of production and inspection areas.
  • Provide details on changes in production equipment for critical processes, inspection equipment for key raw materials, critical components, intermediate products, and finished products.

(c) Changes in Product Manufacturing Processes:

  • If changes occur in critical processes or special processes that impact previously validated or confirmed results, conduct revalidation or reconfirmation.
  • Report situations where revalidation or reconfirmation is carried out for critical processes or special processes.

(d) Significant Supplier Changes:

  • Evaluate substantial changes in suppliers (manufacturers) of major raw materials, critical components, and significant service providers for sterilization, inspection, transportation (especially in cold chain transportation).

3. Annual Operation of Quality Management System:

(a) Organizational Structure and Personnel Training:

  • Provide basic information about organizational structure, departmental setup, responsibilities, and personnel.
  • Detail various training activities conducted by the company, including participation from the legal representative, company leaders, managerial representatives, and personnel influencing product quality.

(b) Production Management and Quality Control:

  • Describe basic conditions in production and inspection areas.
  • Provide information on basic conditions of production equipment for critical processes, inspection equipment for major raw materials, critical components, intermediate products, and finished products, including calibration status.

(c) Procurement Management:

  • Include supplier audits and evaluations based on the “Medical Device Manufacturing Enterprise Supplier Audit Guidelines,” covering on-site and written audits and evaluations.

(d) Customer Feedback:

  • Describe the handling of customer complaints and the disposal of returned products.

(e) Control of Non-Conforming Products:

  • Detail the disposition of non-conforming products, product recalls, measures taken for non-conforming products found during random inspections, and the analysis of reasons.

(f) Establishment of Traceability Systems:

  • Report on the implementation of the Unique Device Identification (UDI) system.

(g) Internal Audits and Management Reviews:

  • Provide information on internal audits conducted during the year, including frequency, identified areas for improvement, and completion status.
  • Detail the conduct of management reviews during the year, including frequency, identified areas for improvement, and completion status.

(h) Monitoring and Reevaluation of Adverse Events:

  • Collect information on adverse events, report as required, and conduct reevaluation activities, including the disposition of serious injury events and submission status of periodic risk assessment reports for medical devices.

4. Other Matters:

(a) Annual Regulatory or Certification Inspection:

  • Detail various regulatory inspections conducted by domestic pharmaceutical supervision and administration departments throughout the year.
  • Include information on inspection nature, timing, major issues found during inspection, conclusions, and rectification status.
  • Report on annual inspections and certification results by other organizations.

(b) Selected Medical Devices in Centralized Quantity Procurement at Various Levels:

  • Provide information on the selection of medical devices in centralized quantity procurement at various levels.

(c) Company Penalties by Pharmaceutical Supervision and Administration Departments:

  • Include information on penalties imposed by pharmaceutical supervision and administration departments at various levels during the year.
  • Report penalties imposed both in China and in the country (region) where the company is located (related to products exported to China)

For the self-inspection report template for overseas manufacturers, please email us at info@ChinaMedDevice.com.

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