On October 31, the State Food and Drug Administration issued the “Appendix to the Quality Management Specification for Medical Device Operations: Quality Management of Enterprises Specializing in Providing Medical Device Transportation and Storage Services” to standardize the quality management of enterprises that specialize in providing medical device transportation and storage services, ensure the quality and safety of medical devices in the transportation and storage links, and promote the high-quality development of the medical device logistics industry. The “Appendix” will come into effect on January 1, 2023.
The “Appendix” encourages enterprises to make full use of new technologies such as informatization, digitization, and the Internet and the Internet of Things in the modern logistics industry to promote the implementation of unique identification of medical devices and promote the full traceability of medical devices. Encourage enterprises to develop intensive, integrated and digital development, adopt new technologies to develop modern logistics, and enhance medical device supply and security service capabilities.
Related interpretations of the “Appendix to the Quality Management Standards for Medical Device Operations: Quality Management of Enterprises Specializing in Providing Medical Device Transportation and Storage Services”:
1. What is the background and significance of the formulation of the “Appendix to the Quality Management Standards for Medical Device Operations: Quality Management of Enterprises Specializing in Providing Medical Device Transportation and Storage Services”?
The quality and safety of medical devices is related to the lives and health of the people. The transportation and storage links in the operation process of medical devices directly affect the quality and safety of the products. The Party Central Committee and the State Council attach great importance to the quality and safety of medical devices and the healthy development of the pharmaceutical industry. The State Council’s Opinions on Accelerating the Construction of a National Unified Market clearly states: “Build a modern circulation network. Vigorously develop third-party logistics, support the construction of digital third-party logistics delivery platforms, promote technological and business model innovation in the third-party logistics industry, cultivate a group of digital platform companies and supply chain companies with global influence, and promote the cost reduction and efficiency improvement of logistics in the whole society.” In order to further implement this. To implement the “Regulations on the Supervision and Administration of Medical Devices”, promote the effective implementation of the “Measures for the Supervision and Administration of Medical Device Operations” and the “Quality Management Standards for Medical Device Operations” to ensure the quality and safety of medical devices in the transportation and storage links, the State Food and Drug Administration organized the formulation of the “Appendix to the Quality Management Standards for Medical Device Operations: Quality Management of Enterprises Specializing in Medical Device Transportation and Storage Services” (hereinafter referred to as the “Appendix”).
The “Appendix” mainly reflects the following characteristics: First, the comprehensive implementation of new regulatory requirements. The purpose is to “ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry” and follow the principles of “risk management, full-process control, scientific supervision, and social co-governance”. The second is to strictly implement the main responsibilities of enterprises. By refining the quality specification requirements, we will clarify the quality responsibilities and obligations of both the entrusting and entrusted parties, ensure the quality and safety of medical device products in the transportation and storage links, and consolidate the main responsibilities of the enterprise. The third is to fully listen to and respond to industry demands. Fully listen to the problems and troubles encountered by enterprises in the promotion of the special medical device transportation and storage service model, conduct comprehensive research and analysis, implement the reform requirements of “decentralization, regulation and service”, solve industry difficulties, and release market innovation vitality. The fourth is to guide the standardized development of the industry and encourage continuous innovation in the industry. Guiding and regulating the healthy, sustainable and high-quality development of companies that specialize in medical device transportation and storage services is crucial to the product quality and safety of the medical device supply chain, improving operating efficiency, and reducing social costs. At the same time, on the basis of ensuring quality and safety and controllable risks, enterprises are encouraged to make full use of new technologies such as informatization, digitization and the Internet and the Internet of Things in the modern logistics industry to promote the implementation of the Unique Identification of Medical Devices (UDI) and promote the full traceability of medical devices.
2. What necessary equipment should enterprises that provide medical device transportation and storage services have in terms of personnel, facilities and equipment to meet the logistics operation and quality management requirements of the entire process of medical device transportation and storage services?
Specializing in providing medical device transportation and storage services is highly professional. The professional quality of employees determines the quality management level of medical device transportation and storage. The “Appendix” clarifies the position configuration and quality requirements for the personnel of enterprises that specialize in providing medical device transportation and storage services, and clarifies the work experience, years, professional and other requirements for personnel in relevant positions.
Enterprises that specialize in providing medical device transportation and storage services should be equipped with equipment and facilities that are commensurate with the scale of transportation and storage services provided. Storage equipment and facilities should include: computer hardware equipment, medical device unique identification collection and reading equipment, shelf systems, loading, unloading, handling and conveying equipment, sorting and warehouse-out equipment, light protection, ventilation, moisture-proof, insect-proof, rodent-proof and other equipment, automatic temperature and humidity monitoring and control equipment, transportation vehicles and equipment.
Enterprises that specialize in providing medical device transportation and storage services should strengthen real-time monitoring and management, monitor operating procedures and abnormal conditions; when transporting and storing products, including cold chain management medical devices, they should also be equipped with backup power supply equipment or use dual-circuit power supply to ensure that effective response measures can be taken in time in an emergency.
At the same time, companies that specialize in providing medical device transportation and storage services are encouraged to adopt innovative technologies and build automated warehouses for medical devices, such as modern automatic warehouses composed of high-rise shelves, automatic sorting machines, automatic inbound and outbound conveyor systems, and peripheral facilities and equipment, to reduce manual errors and improve service capabilities.
3. What role does the computer information system play in the quality management system? What are the main parts?
The computer information system of an enterprise that specializes in medical device transportation and storage services is a core component of its quality management system. It should have multiple functions such as authority, data, records, and reports. It can effectively solidify the processes and quality control points of the quality system, comprehensively retain records of the operating process, and carry the interconnection of different positions and different business entities. Computer information system is not only an effective means to solidify and implement quality systems and quality processes, but also a carrier for true, accurate and complete generation and retention of quality records.
The computer information system of enterprises that specialize in providing medical device transportation and storage services should include warehouse management systems, temperature and humidity monitoring systems, transportation management systems, etc. Medical devices that require cold chain transportation should also be equipped with a cold chain transportation management system. The computer information system should dynamically manage and control the entire process of transportation and storage of medical devices, and collect, record, query, and make statistics on relevant data.
4. What are the quality responsibilities of medical device registrants, filing companies and operating companies when entrusting companies that specialize in transporting and storing medical devices to transport and store medical devices?
The “Appendix” clarifies the responsibilities of both the entrusting party and the enterprise entrusted to provide medical device transportation and storage services. When medical device registrants, filing companies and operating companies entrust enterprises that specialize in providing medical device transportation and storage services to transport and store medical devices, the entrusting party shall bear the responsibility for product operation quality management in accordance with the law.
The principal is the quality responsible entity for medical device operations. The entrusting party shall be responsible for the qualification review, procurement, sales, after-sales service, medical device recall, adverse event monitoring, etc. of its medical device suppliers, purchasers and medical device products, and shall conduct necessary quality supervision on the entrusted enterprises that specialize in providing medical device transportation and storage services.
Enterprises that specialize in providing medical device transportation and storage services are responsible for the specific operations of receipt, acceptance, storage, in-warehouse inspection, out-of-warehouse review, shipment and transportation, as well as assisting the client in returns, recalls, adverse event monitoring, etc.
Click to download the attachment: “Appendix to the Quality Management Standard for Medical Device Operations: Treatment Management of Enterprises Specializing in Providing Medical Device Transportation and Storage Services”