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China Food and Drug Administration
(Order No. 15)
The Provisions for Medical Device Classification were passed by the State Drug Administration at the administration affairs meeting on February 17 of 2000, are hereby promulgated and shall go into effect as of April 10, 2000.
Officer: Zheng Xiaoyu
April 5, 2000
Provisions for Medical Device Classification
| | 国家药品监督管理局令
（第１５号）
《医疗器械分类规则》于２０００年２月１７日经国家药品监督管理局局务会审议通过，现予发布。自２０００年４月１０日起施行。
局长：郑筱萸
二０００年四月五日
医疗器械分类规则
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Article 1 The Provisions are stipulated in accordance with the Regulation on Supervision and Administration of Medical Device to standardize the classification of medical devices.
| | 第一条 为规范医疗器械分类，根据《医疗器械监督管理条例》，制定本规则。
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Article 2 "Medical devices" refer to those instruments, equipment, tools, materials and other objects, including the software attached to them, that are designed to be used either independently or in combination on human body. These devices are used for:
| | 第二条 医疗器械是指：单独或者组合使用于人体的仪器、设备、器具、材料或者其它物品，包括所需的软件。其使用目的是：
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1.Prevention, diagnosis, treatment, monitoring or remission of diseases;
| | （一）疾病的预防、诊断、治疗、监护或者缓解。
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2. Diagnosis, treatment, monitoring, remission or compensation of injury or physical disability;
| | （二）损伤或残疾的诊断、治疗、监护、缓解或者补偿。
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3.Research, replacement or adjustment of anatomical or physiological process;
| | （三）解剖或生理过程的研究、替代或者调节。
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4. Control of pregnancy.
Basically, the effect of these devices on human body is not achieved through means of pharmacology, immunology or metabolism; though they might be resorted to in order to bring about certain supplementary effect.
| | （四）妊娠控制。
其用于人体体表及体内的作用不是用药理学、免疫学或代谢的手段获得，但可能有这些手段参与并起一定辅助作用。
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Article 3 The Provisions are meant to direct the formulation of The Category of Medical Device Classification as well as to determine the classes of newly registered products.
| | 第三条 本规则用于指导《医疗器械分类目录》的制定和确定新的产品注册类别。
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Article 4 The classification of medical devices should be determined by a combined judgment on three respects: its structural characteristics, form of operation as well as conditions for use.
Specifically, their classification can be based on Criteria for Medical Device Classification (see appendix).
| | 第四条 确定医疗器械分类，应依据医疗器械的结构特征、医疗器械使用形式和医疗器械使用状况三方面的情况进行综合判定。
医疗器械分类的具体判定可以依据《医疗器械分类判定表》（见附件）进行。
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Article 5 Guidelines for Medical Device Classification1. The structural characteristics of medical devices. According to their respective structural characteristics, medical devices are divided into active and passive devices.
| | 第五条 医疗器械分类判定的依据：
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2. The forms of operation of medical devices. Medical devices are designated into different forms of operation in accordance with their intended purposes.
| | （一）医疗器械结构特征
医疗器械的结构特征分为：有源医疗器械和无源医疗器械。
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1) Passive devices in terms of their form of operation can be classified as device used for transportation and storage of pharmaceutical liquid, device for alteration of blood, body fluids, medical dressing, surgical instruments; reusable surgical instruments, disposable aseptic device, implantable device, device for contraception and birth control, device for sterilization and cleaning, patient care device, in vitro diagnostic reagent, as well as other passive contacting device or passive supplementary device.
| | （二）医疗器械使用形式
根据不同的预期目的，将医疗器械归入一定的使用形式。其中：
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2) Active devices in terms of their form of operation can be classified as device for treatment through energy, diagnostic monitoring, body fluids transportation and ionized radiation, laboratory instruments and medical sterilizer; as well as other active contacting device or active supplementary device.
| | １．无源器械的使用形式有：药液输送保存器械；改变血液、体液器械；医用敷料；外科器械；重复使用外科器械；一次性无菌器械；植入器械；避孕和计划生育器械；消毒清洁器械；护理器械、体外诊断试剂、其它无源接触或无源辅助器械等。
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3. The conditions for use of medical devices:
．．．．．． | | ２．有源器械的使用形式有：能量治疗器械；诊断监护器械；输送体液器械；电离辐射器械；实验室仪器设备、医疗消毒设备；其它有源器械或有源辅助设备等。
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