China medical device business quality management standards were released by the National Medical Products Administration (NMPA) on December 4, 2023.
The regulation comes into effect on July 1, 2024, and repeals the former China Food and Drug Administration’s Announcement on the Enforcement of the Specification for Quality Management of Medical Devices Business (No. 58 of 2014) of December 12, 2014.
Below you can find an overview of each chapter:
Chapter 1: General Principles
This chapter establishes the foundational principles of the regulations, including objectives, fundamental requirements, adherence, shared responsibilities, risk management, ethical conduct, and the encouragement of digitalization and advanced quality management methods in accordance with the “Regulation on the Supervision and Administration of Medical Devices”, “Measures for the Supervision and Administration of Medical Device Business” and other laws and regulations.
Chapter 2: Establishment and Improvement of Quality Management System
Chapter 2 focuses on establishing and continually improving quality management systems within medical device enterprises. It outlines the roles and responsibilities of key personnel and emphasizes compliance with relevant laws, regulations, and standards. In particular, Article 12 states that Enterprises engaged in the operation of Class II and Class III medical devices shall carry out self-inspection in accordance with these requirements of the quality management self-inspection system, and submit the self-inspection report of the previous year to the drug supervision and administration departments of the municipal and county levels of the locality by 31st March each year.
Chapter 3: Responsibilities and Systems
This chapter details the responsibilities of enterprise leaders in ensuring the quality and safety of medical devices. It underscores the importance of listening to quality management personnel, addressing quality and safety risks, and establishing appropriate work procedures.
Chapter 4: Personnel and Training
Chapter 4 emphasizes personnel qualifications and training requirements. It mandates that key personnel possess a solid understanding of medical device regulations and relevant knowledge. Additionally, it calls for training for personnel in roles related to quality and safety. Enterprises shall conduct induction and regular assessment of relevant personnel such as the person in charge of quality, quality management personnel, after-sales service technicians, after-sales service management personnel, cold chain staff, etc., and they shall be allowed to take up the post or continue to work in this post only after they have passed the assessment.
Chapter 5: Facilities and Equipment
Chapter 5 addresses the selection, design, layout, construction, renovation, and maintenance of storage facilities. It focuses on preventing mix-ups, errors, and contamination of medical devices and encourages the use of computer information systems for traceability.
Chapter 6: Procurement, Receipt, and Acceptance
This chapter outlines procedures for procuring, receiving, and accepting medical devices. It highlights the importance of verifying the legitimacy of suppliers and conducting on-site checks if necessary. Under the condition of ensuring the safety of medical device purchase and sale channels and product traceability, companies may adopt direct sales for medical devices in special situations such as disasters, epidemics, emergencies, clinical urgent treatment, or when dealing with large medical equipment like MRI and CT machines, provided they strengthen quality management, conduct audits of suppliers, buyers, and product qualifications, and establish dedicated records for direct medical device procurement to ensure effective quality tracking and traceability.
Chapter 7: Inventory, storage and inspection
This chapter illustrates detailed requirements for inventory, storage and inspection of medical devices. Enterprises should establish inventory records, acceptance of qualified medical devices should be timely inventory registration. Besides, enterprises should Inspect the appearance, packaging, expiration date and other quality conditions of stocked medical devices.
Chapter 8: Sales, Shipment, and Transportation
Chapter 8 covers the sales, shipment, and transportation and inspection of medical devices. It emphasizes proper training and management of sales personnel, prohibits the sale of unregistered, uncertified, expired, or obsolete medical devices. Companies in the medical device wholesale business must attach a shipment note during product release, bearing their company’s or a specialized transportation and storage service provider’s out-of-warehouse seal. The note should include essential details like supplier and recipient information, device specifications, and transportation conditions. In direct sales, two shipment notes should be issued, one for the direct sales enterprise and one for the purchaser, with clear identification of the direct sales and reasons for it. Besides, companies must adhere to relevant regulations and transportation operating procedures for the transportation of medical devices. This involves selecting appropriate transportation means and routes, ensuring product protection during transportation and keeping detailed transportation records that include information such as recipient details, transportation method, medical device specifications, registration or record numbers, batch/serial numbers, quantities, shipping dates, and, when applicable, carrier details and vehicle information.
Chapter 9: After-Sales Services
Chapter 9 addresses the provision of after-sales services in line with supplier agreements and customer expectations. Companies can either offer after-sales technical services themselves or have them provided by suppliers or third-party organizations. When using third-party organizations for after-sales support, companies should select service providers with quality assurance capabilities, establish written quality assurance agreements, define mutual quality responsibilities and obligations, and clearly outline the scope of after-sales service and quality management requirements.
Chapter 10: Supervision and Management
The final chapter, Chapter 10, outlines the responsibilities of regulatory authorities and their role in overseeing compliance with these regulations. It establishes mechanisms for monitoring and inspection to ensure adherence to quality management standards.
Further information
Read the original announcement on medical device business quality management standards.
Read our previous articles on quality management of medical device business operations in China – draft regulation issued by NMPA.
Discover our services for medical device registration, renewals and NMPA Legal Agent.
