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Laws & Regulations - Medical Devices - Provisions for Medical Device Classification
Provisions for Medical Device Classification
2011/7/13 9:27:45Source: Hits:

(Order No. 15 of SDA)
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.
April 5, 2000

Provisions for Medical Device Classification
Article1 The Provisions are stipulated in accordance with the Regulation on Supervision and Administration of Medical Device to standardize the classification of medical devices.

Article2 "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:
1.Prevention, diagnosis, treatment, monitoring or remission of diseases;
2. Diagnosis, treatment, monitoring, remission or compensation of injury or physical disability;
3.Research, replacement or adjustment of anatomical or physiological process;
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.

Article3 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.

Article 4 The classification of medical devices should be determined by a combined judgement 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).

Article 5 Guidelines for Medical Device Classification
1. The structural characteristics of medical devices
According to their respective structural characteristics, medical devices are divided into active and passive devices.
2. The forms of operation of medical devices
Medical devices are designated into different forms of operation in accordance with their intended purposes.
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.
2) Active devices in terms of their form of operation can be classified as device for treatment through energy, diagnostic monitoring, body fluids transp

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