China Medical Device QMS Self-assessment Annual Report must be submitted by March 31, 2025

China Medical Device QMS Self-assessment Annual Report Overview

According to the regulations of the "Regulations for the Supervision and Administration of Medical Devices," medical device registrants, filers, and entrusted manufacturers are required to conduct annual self-assessment work in accordance with the requirements of the "Medical Device Production Quality Management Specification" and its annexes, and to prepare and submit the annual self-assessment report of the quality management system. This report aims to comprehensively assess the operation of the enterprise's quality management system to ensure the safety and effectiveness of medical devices.

Key Deadline: March 31, 2025

According to NMPA requirement, the 2024 QMS Self-assessment Annual Report must be submitted by March 31, 2025, covering the period from January 1, 2024, to December 31, 2024. Failure to submit on time or incomplete reports may result in suspension of product sales, fines, or even cancellation of registration certificates. International manufacturers need to start data preparation as early as possible and coordinate domestic and foreign teams to complete information integration.

Requirements for Preparing QMS Self-assessment Annual Report

Summary Section
Annual Significant Changes
- Product Design Change Situation: Changes related to product safety, performance, and intended use need to complete evaluation, verification, or confirmation.
- Changes in Production and Inspection Areas and Equipment: Describe changes in production and inspection areas, as well as changes in key production equipment and inspection equipment.
- Changes in Product Production Processes: Changes in key processes and special processes need to be re-verified or re-confirmed.
- Significant Supplier Changes: Changes in suppliers of main raw materials and key components need to be evaluated.
Annual Operation of Quality Management System
- Organization and Personnel Training Situation: Including department setup, responsibilities, person-in-charge situation, and various training situations.
- Production and Quality Control Situation: Involving basic information of production and inspection areas, basic information of key process production equipment and inspection equipment, and verification and calibration situation.
- Procurement Management Situation: Supplier audit and evaluation situation.
- Customer Feedback Situation: Disposal of customer complaints and returned products.
- Control of Non-conforming Products: Disposal of non-conforming products, product recall situation, etc.
- Establishment of Traceability System: Implementation of UDI.
- Internal Audit and Management Review Situation: Number of internal audits and management reviews, number of items to be improved, and completion situation.
- Situation of Adverse Event Monitoring and Re-evaluation Work: Collection of adverse event information and reporting and re-evaluation work in accordance with regulations.
Other Points
- Annual Acceptance of Regulatory or Certification Inspection: Including supervision and inspection situations of various levels of drug regulatory departments.
- Situation of Winning in Centralized Volume-based Procurement of Medical Devices.
- Situation of Penalties Accepted by Enterprises: Penalties accepted from various levels of drug regulatory departments.

How to Prepare QMS Self-assessment Annual Report

Familiarize with Regulations and Guidelines: Carefully read the "Guidelines for the Preparation of Annual Self-Inspection Report of Medical Device Quality Management System" to understand the specific requirements and format of the report.
Collect and Organize Data: Collect data on production, quality, procurement, sales, and other aspects of the enterprise to ensure the accuracy and completeness of the data.
Prepare the Report: Fill in the report content item by item according to the requirements of the guidelines to ensure the truthfulness and reliability of the information.
Internal Audit: Conduct an internal audit before submitting the report to ensure that the report content meets regulatory requirements.
Submit on Time: Submit the report to the relevant drug regulatory department before March 31.

Impact on Overseas Manufacturers

For overseas medical device manufacturers, through QMS Self-assessment Annual Report, enterprises can comprehensively access whether their quality management system meets the requirements of Chinese regulations and promptly identify and improve problems.

Support from Cisema

As a professional regulatory consulting firm, Cisema can provide comprehensive support and services to overseas manufacturers, including but not limited to:

Regulatory Consulting: Provide professional consulting on Chinese medical device regulations and standards to help enterprises understand regulatory requirements.
Report Preparation Guidance: Assist enterprises in preparing annual self-inspection reports that meet the requirements to ensure the accuracy and completeness of the reports.
Internal Audit Support: Provide internal audit services to help enterprises identify and improve problems in the quality management system.
Training Services: Provide training on relevant regulations and quality management for enterprises to improve the professional level of enterprise personnel.

Why is it important?

It highlights the upcoming deadline (March 31) for the submission of the annual self-inspection report of medical device quality management system in China. It provides detailed guidelines and templates for overseas manufacturers to understand and comply with Chinese regulations. For more details, refer to the original announcement on the QMS self-assessment annual report guidelines.

For instructions on preparing the medical device quality management system self-assessment annual report, contact Cisema to request the English translation.