The National Medical Products Administration of China has issued a newly revised “Medical Device Operations Quality Management Standards” (hereinafter referred to as the “Standards”) to adapt to the needs of medical device business supervision and quality management under the new situation, standardize medical device business activities, and ensure the quality and safety of medical devices. The “Standards” will come into effect on July 1, 2024. The “Announcement on the Implementation of Quality Management Standards for Medical Device Operations” (No. 58, 2014) issued by the China Food and Drug Administration will be abolished at the same time.
Compared with the “Standards” of 2014 version, the content of the new version has changed significantly, with a total of ten chapters and 116 articles, including general principles, quality management system establishment and improvement, responsibilities and systems, personnel and training, facilities and equipment, procurement, receipt and acceptance, warehousing, storage and inspection, sales, delivery and transportation, after-sales service, and 10 chapters of supplementary provisions. For more details, please contact us.
The new “Standards” were revised from the original nine chapters and 66 articles to ten chapters and 116 articles. Among them, the chapter “Establishment and Improvement of Quality Management System” is a new chapter, including the establishment of quality management system, formulation of quality policy and quality objectives, fulfillment of main responsibilities, system self-examination, continuous improvement of quality management system, etc. The titles of other chapters remain unchanged, but the content has been adjusted and expanded to be closer to the actual situation of the industry to provide detailed guidance.
The “General Provisions” chapter of the “Standards” adds new content on primary responsibilities, specification implementation, electronic licenses, and encouragement of innovation, clarifying that medical device registrants and filers are responsible for the safety and effectiveness of marketed medical devices in accordance with the law, and medical device operating enterprises (hereinafter) (referred to as “enterprises”) is responsible for their business operations. Enterprises are encouraged to use advanced quality management tools and methods to implement quality management and continuously improve the quality management system. The digital, intelligent, and green development of enterprises are encouraged to improve the efficiency and quality safety of medical device supply chain, and to promote high-quality development of the industry.
- The “Standards” set out requirements for new business forms such as medical device automatic vending machines and third-party logistics. Taking the medical device automatic vending machine as an example, the “Standards” point out that the automatic vending machine is an extension of the medical device retail business premises. For its operating entities, setting quantity and location, functions, internal display environment, establishment of after-sales mechanism, and display of the entity’s license, storage and shipment, regular inspection, issuance of sales vouchers, etc. The “Standards” put forward specific requirements.
- The “Standards” clearly stipulate that enterprises can build a national or regional multi-warehouse collaborative logistics management model by setting up warehouses across administrative regions and entrusting enterprises across administrative regions to provide medical device transportation and storage services. Enterprises should strengthen quality management of warehouses set up across administrative regions, and be equipped with computer information systems that are interconnected with the operating enterprise headquarters and capable of real-time exchange of medical device storage, incoming and outgoing data.
- The “Standards” clearly clarifies the relevant requirements for products sold after clinical confirmation. In clinical practice, some medical devices need to be selected by medical institutions before they can be confirmed for sale, such as orthopedic implant medical devices. The “Standards” require enterprises to strengthen quality review before shipment of medical devices that can be confirmed for sale only after they are selected by medical institutions. They must meet their product quality and safety requirements before shipment, and keep records of shipment quality review. For unused products returned by medical institutions after selection, enterprises should strengthen process quality record management to ensure that the outbound quality review records, sales records, and return records of products selected and sold by medical institutions are true, accurate, complete, and traceable.
- The “Standards” have added new provisions for the mixed storage of non-medical devices. It clarifies that when the products stored in the warehouse include non-medical device products, warehouse zoning management should be done well. The contamination risk of non-medical device products to the storage environment and personnel should be fully assessed, and measures should be formulated to ensure the safety of the storage environment of medical devices.
The newly revised “Standards” implement the “four most stringent” requirements, fully implement the new “Medical Device Supervision and Management Regulations” and “Medical Device Operation Supervision and Management Measures”. At the same time, it combines the medical device supervision and enterprise quality management practices to deepen the reforms to delegate power, streamline administration and optimize government services in order to promote the high-quality development of the medical device industry and release the vitality of market innovation.
