Part 5 of our blog series was focused on the Manufacturers' compliance with China's GMP. We concluded that although there might be some shared requirements between China's GMP and ISO 13485:2016, it's crucial to acknowledge that China GMP brings forth a set of additional Quality Management System (QMS) obligations that manufacturers must follow as they span various aspects, including product quality, safety, personnel health, and operational practices.
Further down the supply chain, compliance with Good Supply Practice (GSP) mandates distributors to address systematically risks across the complete supply chain, encompassing procurement, delivery acceptance, storage, sales, transportation, and after-sales services, with the quality management system's design and implementation align with the risk profiles of the products.
At the end of 2023, China Health Authority NMPA announced a new Good Supply Practice (GSP) that will replace the current GSP Order number 58. The new GSP (
Order number 153) has significantly extended from the existing 9 chapters and 66 articles to 10 chapters and 166 articles and will be implemented from July 1, 2024. The underlying driving force for introducing the new GSP is encouraging the supplier to continuously improve its quality system by utilizing more advanced methods and tools and promoting supply chain efficiency and safety to accommodate the dynamic distribution practice. Let’s review what differences this new GSP has brought to our attention.
A new chapter, “Establishment and Improvement of quality management system” The first new chapter specifies that the distribution company is required to establish a Quality Management System (QMS) which shall match its operational scope and scale. The QMS shall include quality management documentation, organizational structure, personnel, infrastructure, and equipment. The distributors shall ensure that the quality policies and objectives are effectively implemented throughout the entire process of business activities. Besides the class III medical device distributors, the new GSP requires class II device distributors to hand in annual self-inspection reports of the previous year to the local city and county-level NMPA regulatory department before March 31 of the next year.
Expanding technological advancements The second update involves the identification and incorporation of novel regulatory elements to align with evolving regulatory approaches. The utilization of Unique Device Identifiers (UDI) has been expanded, particularly in product acceptance, warehouse delivery, and traceability. Emphasis is placed on endorsing computerized systems for enhanced warehouse management, distribution traceability, and the efficient handling of certificates and qualifications.
Innovative distribution strategies The third modification involves the incorporation of innovative distribution management strategies to align with evolving operational requirements. These include methods such as device distribution through vending machines, cross-jurisdictional collaboration among multiple warehouses, direct purchase quality management, and product management after post-production, etc. In exceptional circumstances like disasters, epidemics, emergencies, or clinical emergency treatment, distributors may engage in direct purchase and sale of medical devices. Notably, purchased medical devices under such circumstances are not retained in the distributors' warehouse but are promptly dispatched to the purchaser.
Enhanced warehouse management requirements The next change concerns storage management, which has been revised and refined, particularly within the cold chain supply. For example, when storing in cold storage, a reasonable storage area should be determined based on the cold storage verification report and the air outlet of the refrigeration unit should be avoided from being obstructed. Standardized operations should be carried out according to the packaging and label requirements when handling, stacking, and placing medical devices. The stacking height and placement direction should meet the packaging diagram requirements and be stored appropriately according to the load-bearing range of shelves and pallets to avoid damage to medical devices. Medical devices and non-medical devices sold in combination shall be stored separately. The pollution risk of non-medical device products to the storage environment should be thoroughly evaluated, and measures should be formulated to ensure the safety of the medical device storage environment.
Comprehensive medical device distribution records The new GSP elaborates on the medical device distribution and sales records. Very detailed files are needed to distribute the devices, which include the name of the supplier, name of medical device registrant/filer, the entrusted production company, name, model, specification, registration certificate number/filing number of devices, production batch number or serial number, service life or expiration date, the number of medical devices, transportation and storage conditions of medical devices, name of enterprise entrusted in providing medical device transportation and storage services.
Transportation process Distributors must select the appropriate transportation tools and routes to ensure the protection, quality, and safety of the devices, maintaining comprehensive transportation records. These records should encompass details such as the receiving unit's name, address, contact information, transportation method, medical device particulars (name, model, specification, registration certificate number or filing number), production batch number or serial number, unit, quantity, and delivery date. When outsourcing transportation to a third party, it is essential to record the carrier's name and waybill number. Internal transportation requires recording the vehicle's license plate number and the details of the transportation personnel.
Reinforced after-sales service requirements The latest GSP amendment focuses much more on the updated requirements for after-sales service. Manufacturers can utilize their resources or engage third-party services for after-sales support. Service organizations are mandated to possess quality assurance capabilities, enter into a documented quality agreement, define quality responsibilities and obligations, and specify the scope and quality management requirements of after-sales service. Regular assessments are imperative to evaluate the capabilities of service institutions, ensuring the quality, safety, and traceability of the after-sales service process. Adequate professional training is required for after-sales personnel involved in installation, repair, and technical training. Service management personnel should demonstrate proficiency in regulations related to complaints, adverse event monitoring, recalls, the quality management system, and the specifics of the distributed devices.
As we approach the end of 2023, it is crucial for medical device distributors to be well-versed in the significant changes outlined in China's new Good Supply Practice (GSP) under Order number 153. These updates touch on various aspects, from the establishment of a robust QMS to embracing technological advancements such as the expanded use of UDI and computerized systems. Innovative distribution strategies, enhanced warehouse management requirements, and comprehensive records for distribution and sales are key highlights. Additionally, ultracareful attention to the transportation process and reinforced after-sales service requirements underscore the commitment to quality, safety, and compliance. These insights empower distributors to navigate the evolving landscape proactively and usher in a new year of success and compliance in the dynamic medical device distribution sector.
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