To the Health Commissions and Administrations of Traditional Chinese Medicine in all provinces, autonomous regions, municipalities directly under the central government and Xinjiang Production and Construction Corps,
The National Health Commission of the People’s Republic of China and the State Administration of Traditional Chinese Medicine formulated the Measures for the Management of Medical Consumables in Medical Institutions (Trial) in order to standardize the management of medical consumables in medical institutions, promote the rational and standard use of medical consumables and guarantee the quality and safety of medical treatment. (The document can be downloaded in the column of medical affairs and services on the website of the National Health Commission of the People’s Republic of China.) It is hereby printed and distributed to you for compliance and implementation according to actual situation.

National Health Commission of the People’s Republic of China, State Administration of Traditional Chinese Medicine
June 6, 2019


Interpretation of Measures for the Management of Medical Consumables in Medical Institutions (Trial)

I. Background

Featuring various types and specifications, medical consumables are widely used and closely related to medical quality, medical safety and medical expenses. Standardizing the use and management of medical consumables is of great significance for deepening the reform of the medical and health system and safeguarding people’s health. In 2018, the National Health Commission of the People’s Republic of China initiated the formulation of relevant regulations on management of medical consumables and commissioned relevant associations to draft the Measures for the Management of Medical Consumables in Medical Institutions (Discussion Paper). Since then, the Commission has organized many experts in the fields of medical management, procurement management and clinical medicine to conduct research and modification, conducting investigations and surveys in many places to collect the opinions from local health authorities and medical institutions. Based on that, the Measures for the Management of Medical Consumables in Medical Institutions (Exposure Draft) was developed. The opinions from the relevant departments of the Commission, the Department of Medical Administration in State Administration of Traditional Chinese Medicine, the Health Bureau of the General Logistics Department of the Central Military Commission and the health authorities of provincial levels were collected. After further modification and improvement, the Measures for the Management of Medical Consumables in Medical Institutions (hereinafter referred to as “Measures”) was developed.

II. Main Content

(I) Specify the object and content involved in management. The Measures clearly define and classify medical consumables, and specify the whole process management of the selection, procurement, acceptance, storage, distribution, clinical use, monitoring and evaluation of medical consumables.
(II) Set up the list of medical consumables for medical institutions. Medical institutions are required to formulate a list of medical consumables in accordance with the principles of legality, safety, effectiveness, suitability and economy, and make regular adjustments. At the same time, medical institutions are required to limit the quantity of the types and specifications of medical consumables and the number of suppliers for medical consumables with the same or similar functions should be limited, too.
(III) Specify the procurement requirements for medical consumables. The unified management is required for the procurement of medical consumables. Other departments should not engage in the procurement of medical consumables and should not use the medical consumables purchased and supplied by other departments other than the management department of medical consumables.
(IV) Establish a level-to-level management system for clinical use of medical consumables. The clinical use of medical consumables is subject to three levels of management. In the Measures, medical consumables are divided into three levels, namely level I, II and III according to the Catalog of Medical Device Classification where medical devices are divided into class I, II and III. Medical consumables of level I are used by health workers, medical consumables of level II are used by trained health workers and medical consumables of level III are used by health workers with relevant technical operation qualifications in accordance with the applicable regulations on medical technology management. For implantable medical consumables, preoperative discussion should be conducted before use.
(V) Illuminate regulatory measures. Medical institutions are required to establish a management information system of medical consumables, covering the selection, procurement, acceptance, warehousing, storage, inventory, claims, delivery, clinical use, quality event report, adverse reaction monitoring, key monitoring, supernormal warnings, and comments, so that the whole life cycle of every medical consumable can be traceable. At the same time, the purchase and sale management of medical consumables will be included in the field of industry construction management, and the investigation and punishment for violations of the “Nine Don’ts” in the management of medical consumables will be intensified.

III. Next Work Plan

To guide local health administration departments and administrative departments of traditional Chinese medicine to strengthen the supervision and regulation on management of medical consumables in medical institutions, and to conduct regular supervision and inspection.