Recently, the National Health Commission ("NHC") and the National Administration of Traditional Chinese Medicine ("NATCM") have jointly issued the Administrative Measures for Medical Consumables for Medical Institutions (for Trial Implementation) (the "Measures"), with effect from September 1, 2019.
The Measures provide for the definition and classification of medical consumables, and clearly state that whole-process administration will be imposed on work related to medical consumables, including selection, procurement, receiving inspections, storage, distribution, clinical use, monitoring, and evaluation. The Measures state that medical consumables will be subject to unified procurement, adding that clinical use of medical consumables is administered at three different levels, and for this purpose, medical consumables are divided into three classes, i.e. Class I, Class II and Class III. Class I medical consumables are utilized by medical technicians, while Class II medical consumables are used by qualified medical technicians after they have received the necessary training, and Class III medical consumables, as stipulated by relevant administrative provisions on medical technologies, are used by those medical technicians who obtain the qualification to make relevant technical operations. Furthermore, the Measures require that medical consumables usable by medical institutions shall fall in a limited range of varieties, to the limited specifications and in a limited quantity, and the number of enterprises supplying the medical consumables with the same or similar functions should be controlled as well.