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The Ministry of Health and five other departments jointly issued the "Guidelines for Centralized Procurement of High-Value Medical Consumables (Trial)."
Procurement of high-value medical consumables across various regions suffers from issues such as low concentration, high procurement prices
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The “Plan and Implementation Scheme for Deepening the Reform of the Medical and Health System during the 12th Five-Year Period” (Guofa [2012] No. 11) explicitly calls for “actively promoting centralized procurement of high-value medical consumables and medical devices.” In accordance with the requirements for deepening the reform of the medical and health system, and in order to standardize the centralized procurement of high-value medical consumables across various regions, the Ministry of Health and five other departments have jointly developed the “Norms for the Centralized Procurement of High-Value Medical Consumables” (hereinafter referred to as the “Norms”). The following is an explanation of the preparation process:
I. Background Information on the Centralized Procurement of High-Value Medical Consumables
Before 2004, the procurement of high-value medical consumables across various regions suffered from issues such as low concentration, high procurement prices, significant price disparities among regions, heavy burdens on enterprises, frequent occurrences of improper practices in buying and selling, and irregular behavior by intermediary agencies. To standardize the procurement practices of high-value medical consumables in medical institutions, combat commercial bribery, and effectively reduce the financial burden of medical expenses on patients, in August 2004, our ministry organized a pilot program involving centralized procurement of three categories of high-value medical consumables—cardiac intervention consumables, artificial joints, and cardiac pacemakers—from tertiary-level medical institutions in eight provinces and cities, including Beijing. As a result of this centralized procurement, the prices of the aforementioned high-value consumables were significantly reduced.
From 2008 to 2009, building on the pilot work conducted in eight provinces and cities, our ministry commissioned the Center for International Cooperation and Exchange of the Ministry of Health to carry out two rounds of centralized procurement of selected high-value medical consumables nationwide. These purchases primarily involved high-value medical consumables such as cardiac pacemakers and cardiac intervention devices (including peripheral intervention devices, neurointervention devices, and electrophysiological devices). In 2010, we also added new products to the procurement list. Through centralized procurement, the purchase prices of four categories of high-value medical consumables were further reduced, thereby alleviating the financial burden on patients. At the same time, this initiative helped explore models and accumulate experience for localities seeking to implement centralized procurement of high-value medical consumables. In accordance with relevant requirements, starting in 2010, the responsibility for organizing and implementing centralized procurement of high-value medical consumables has been transferred to the respective provinces (autonomous regions, and municipalities).
In accordance with the requirements for deepening the reform of the medical and healthcare system, various regions have actively explored and implemented centralized procurement of high-value medical consumables. Many provinces (autonomous regions and municipalities), including Sichuan, Ningxia, Jiangsu, Hubei, and Zhejiang, have, based on their local conditions, carried out centralized procurement of certain high-value medical consumables at the provincial level, achieving positive social outcomes.
II. The Preparation Process of the “Work Standards”
To further guide localities in carrying out centralized procurement of high-value medical consumables, and based on a comprehensive summary of the experiences gained from centralized procurement of such consumables nationwide as well as in selected provinces, we have initiated the drafting of the “Work Guidelines.” During the drafting process, we held several specialized symposiums to thoroughly solicit opinions and suggestions from various stakeholders, including relevant experts, selected provinces, medical institutions, industry associations, and enterprises. As a result, we have prepared a draft of the “Work Guidelines” for public comment.
On September 21, 2012, we officially released the draft of the “Work Standards” for public comment. We received a total of 65 suggestions for revision from all sectors of society. After careful review and analysis, we adopted all the reasonable suggestions, ultimately resulting in the “Work Standards for Centralized Procurement of High-Value Medical Consumables (Trial Implementation).”
III. Main Contents of the “Work Standards”
The “Work Standards” consist of 11 chapters and 50 articles, and primarily cover the following aspects:
(1) Regarding the scope of procurement: Guided by the principles of highlighting key areas, driving broader coverage through targeted efforts, and tailoring approaches to local conditions, the high-value medical consumables covered this time include vascular intervention, non-vascular intervention, orthopedic implants, neurosurgery, electrophysiology, pacemakers, extracorporeal circulation and blood purification, and ophthalmic materials. Localities may select items from this list based on their own specific circumstances and operational needs, or they may independently choose products beyond this scope. At the same time, all qualified non-profit medical institutions sponsored by county-level and above people's governments and state-owned enterprises (including those with state-owned controlling interests) are required to participate fully in centralized procurement when purchasing high-value medical consumables.
(2) Regarding the procurement organization model: Adhering to the principles of openness and transparency, fair competition, impartiality and integrity, and scientific rigor and honesty, we will implement centralized online procurement of high-value medical consumables, led by the government and organized at the provincial (autonomous region or municipality) level. Medical institutions and manufacturers and distributors of medical consumables must conduct their procurement through the centralized procurement platforms established by each province (autonomous region or municipality), thereby ensuring unified organization, a single platform, and unified oversight. The centralized procurement cycle will, in principle, be once every two years, and the period for adding new products shall not exceed one year.
(3) Regarding the composition of procurement agencies: Provinces (autonomous regions and municipalities) will no longer establish new centralized procurement agencies. Instead, they will continue to rely on the existing leading bodies, management bodies, working bodies, and supervisory bodies responsible for centralized drug procurement. The “Work Standards” also clearly define the division of responsibilities among these relevant agencies in the centralized procurement process.
(4) Regarding the parties involved in centralized procurement. The institutions primarily involved in centralized procurement include medical institutions and manufacturers and distributors of medical consumables. The "Work Standards" clearly define the responsibilities, obligations, rights, and duties of each institution in the centralized procurement process. Medical institutions are required to procure high-value medical consumables listed in the approved centralized procurement catalog exclusively through the non-profit centralized procurement platform established by the government. They must sign purchase and sale contracts with medical consumable manufacturers or their authorized distributors in accordance with the provisions of the "Contract Law," clearly specifying details such as product variety, specifications, quantity, price, payment terms, performance methods, and liability for breach of contract. Centralized procurement adopts a direct bidding system for medical consumable manufacturers. Medical consumable manufacturers participating in centralized procurement activities shall provide supporting documentation including qualification certificates, ex-factory (port-of-entry) prices for the past 2-3 years, letters of commitment guaranteeing supply, and a list of authorized distributors. They must also deliver goods promptly as stipulated in the contract.
(5) Regarding the procurement catalog and procurement methods: The centralized procurement management agencies of each province (autonomous region, municipality) are responsible for organizing and preparing the centralized procurement catalog for high-value medical consumables within their respective administrative regions. For high-value medical consumables included in the centralized procurement catalog, procurement shall be conducted through open tendering, invitation bidding, and other methods recognized by national laws and regulations. Each province (autonomous region, municipality) should actively explore and promote procurement models that link volume to price.
(6) Regarding the procurement platform: The centralized procurement platform is a procurement and regulatory platform established by the government. The government owns and has the right to use the platform. The hardware setup should leverage the existing centralized drug procurement platform, while the development and management of the software platform must be secure and reliable, feature-rich, data-complete, subject to stringent oversight, assigned to dedicated personnel, and governed by strict access controls.
(7) Regarding the implementation of centralized procurement: Centralized procurement must establish a scientific evaluation methodology and adhere to the principles of "quality first, reasonable pricing, and appropriate cost-effectiveness." It should take into account factors such as clinical efficacy, quality standards, technological level, and scope of application, and conduct a comprehensive evaluation of quality, price, service, and reputation. The "Work Standards" also clearly define the key procedures for centralized procurement.
(8) Regarding expert management: The centralized procurement management agency is responsible for establishing and managing the expert database, while the centralized procurement working body is responsible for utilizing these experts in centralized procurement activities. The centralized procurement expert database is organized into different groups based on the specialized application characteristics of the products, and is composed of clinical experts as well as experts in equipment procurement and management. The “Work Standards” clearly define the basic qualifications that experts must meet, their rights and obligations, the exit mechanism, and the method for selecting review experts.
(9) Regarding Questions, Complaints, Supervision and Management, and Penalties: The centralized procurement agency shall promptly respond to any questions or inquiries raised by medical consumables manufacturers and distributors. The centralized procurement management agency shall establish a complaint hotline and set up an electronic mailbox, making these channels publicly available so that medical institutions, medical consumables manufacturers and distributors, and the general public can monitor the performance of relevant personnel in fulfilling their duties. The “Work Standards” require the establishment of standardized centralized procurement workflows, supervision systems, and multi-level review mechanisms, ensuring that every stage and procedure is subject to rigorous oversight. The “Work Standards” also clearly define the key areas of supervision and management for the centralized procurement oversight body, propose the implementation of a dynamic management system for adverse records of medical consumables manufacturers and distributors, and specify the penalty measures applicable to medical institutions, medical consumables manufacturers and distributors, and centralized procurement staff.
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