The Revision of Good Supply Practice for Medical Devices
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE:
December 4, 2023
EFFECTIVE DATE:
July 1, 2024
On December 4, 2023, the National Medical Products Administration revised and released the Good Supply Practice for Medical Devices (“GSP”), which shall take effect as of July 1, 2024. The revision aims to better align with current business practices and new quality management standards, further regulating the operations of medical devices and providing meticulous regulatory guidance.
The revised GSP has expanded from nine chapters and 66 articles to ten chapters and 116 articles, adding a new chapter on “Establishment and Improvement of Quality Management Systems.” This chapter outlines the core elements of building a quality system, setting policies and goals, fulfilling primary responsibilities, implementing self-inspection mechanisms, and continuous improvement.
In the “General Principles” chapter of the GSP, new content has been added regarding primary responsibility, standardized implementation, electronic certification, and encouragement of innovation. It clarifies that medical device registrants and filers are legally responsible for the safety and efficacy of medical devices on the market, and medical device businesses are responsible for their own business operations. Medical enterprises are encouraged to use advanced quality management tools and methods to implement quality management and continuously improve their quality management systems. For instance, it is suggested that enterprises develop in a digital, intelligent, and green direction, enhancing the efficiency and quality safety of the medical device supply chain, and promoting high-quality development of the industry.
The revised GSP also makes requirements for new business forms such as medical device vending machines and third-party logistics. Taking medical device vending machines as an example, the GSP specifies requirements for the business entity, the number and location of installations, functionality, internal display environment, establishment of after-sales mechanisms, display of main certificates, storage and delivery, regular inspections, and issuance of sales receipts.
Reference:
《國家藥監(jiān)局關(guān)于發(fā)布醫(yī)療器械經(jīng)營質(zhì)量管理規(guī)范的公告》
