Laws & Regulations/
Provisions for Medical Device Classification (2000)

(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

Article 1 The Provisions are stipulated in accordance with the Regulation onSupervision and Administration of Medical Device to standardize the classificationof medical devices.

Article 2 "Medical devices" refer to those instruments,equipment, tools, materials and other objects, including the software attachedto them, that are designed to be used either independently or in combination onhuman body. These devices are used for:

1.Prevention, diagnosis, treatment, monitoring or remission of diseases;

2. Diagnosis, treatment, monitoring, remission or compensation of injuryor physical disability;

3.Research, replacement or adjustment of anatomical or physiologicalprocess;

4. Control of pregnancy.

Basically, the effect of these devices on human body is not achievedthrough means of pharmacology, immunology or metabolism; though they might beresorted to in order to bring about certain supplementary effect.

Article 3 The Provisions are meant to direct the formulation of TheCategory of Medical Device Classification as well as to determine the classesof newly registered products.

Article 4 The classification of medical devices should be determined bya combined judgement on three respects: its structural characteristics, form ofoperation as well as conditions for use.

Specifically, their classification can be based on Criteria for MedicalDevice Classification (see appendix).

Article 5 Guidelines for Medical Device Classification

1. The structuralcharacteristics of medical devices

According to theirrespective structural characteristics, medical devices are divided into activeand passive devices.

2. The forms of operation ofmedical devices

Medical devices aredesignated into different forms of operation in accordance with their intendedpurposes.

1) Passive devices in termsof their form of operation can be classified as device used fortransportation and storage of pharmaceutical liquid, device for alteration ofblood, body fluids, medical dressing, surgical instruments;
reusable surgical instruments, disposable aseptic device, implantable device,device for contraception and birth control, device for sterilization andcleaning, patient care device, in vitro diagnostic reagent, as well as otherpassive contacting device or passive supplementary device.

2) Active devices in terms of their form of operation can be classified asdevice for treatment through energy, diagnostic monitoring, body fluids transportationand ionized radiation, laboratory instruments and medical sterilizer; as wellas other active contacting device or active supplementary device.

3. The conditions for use of medical devices:

Medical devices may be divided into contacting or inserted devices andnon-contacting devices based on their conditions for use, which include thepossible injuries they might entail as well as their impact on the medicaltreatment.

1) Contacting or inserteddevices

a. Term of use: temporaryuse, short - term use, long-term use;
b. Particular parts of the human body being contacted:
skin, cavity and tract; trauma or body tissue; blood circulation system orcentral nervous system;
c. The degree of injuries caused by malfunction of active devices:
minor injuries, injuries, serious injuries.

2) Non-contacting Devices

The impact these deviceshave on treatment ranges from: basically no impact, indirect impact,substantial impact.

Article 6 Principles for Medical Device Classification

1. The classification of medical devices should be conducted in accordancewith The Criteria for Medical Device Classification.

2. The criteria for medical device classification are based on theintended purpose and the function of a medical device. To the same product, ifthe intended purpose or form of operation be different, its class shall bedetermined respectively.

3. For the medical device to be used in combination with another, theclassification of each should then be dealt with separately. Accessories tomedical devices should be classified independently from the master devicerespecting its own conditions.

4. For the medical device to be used on several parts of the human body,the classification should be determined on the basis of the risks involved inits intended purposes and form of operation.

5. Software that controls the functions of the medical device should bedesignated to the same class of its associated medical device.

6. If one medical device pertains to two classes at the same time, thehigher one is adopted.

7. Those products that are designed to monitor or affect the majorfunctions of a medical device should be designated to the same class of thedevice being monitored or affected.

8. The State Drug Administration shall readjust as it sees fit theclassification of certain medical devices that call for special administration.

Article 7 The State Drug Administration is competent authority takecharge of the classification of medical devices. In case a medical device failsto be designated according to The Category of Medical Device Classification,its classification then should be based on The Regulation for Medical DeviceClassification at the discretion of the provincial drug administration, theresult of which should be submitted to the State Drug Administration forapproval.

Article 8 The terms used in the provisions are defined as follows:

1. Intended purpose: the desired effect of a medical device that isillustrated in its product specification, label or materials for publicity.

2. Risk: the possible injuries that may be caused by the medical deviceand the seriousness of the injury.

3.Term of use:

1) Temporary Use: the intended term for consecutive use of the device iswithin 24 hours;
2) Short-term Use: the intended term for consecutive use of the device rangesfrom 24 hours to 30 days;
3) Long-term Use: the intended term for consecutive use of the device is morethan 30 days.
4) Term for consecutive use: the actual working time of a device without anystop in accordance with its intended purpose.

4. Parts being operated upon and the device:

1) Non-contacting devices: devices that do not directly or indirectlycontact the body of a patient;
2) Surface contacting devices: including devices contacting the following partsof the human body:

a. skin: devices that only contact the surface of the unwounded skin;

b. mucous membrane: devices that contact the mucous membrane;

c. wounded surface: devices that contact the wounded area or the surfaceof other injured areas.

3) Devices for surgical insertion: devices that are entirely or partlyinserted into the body through the surface of body by surgery contacting thefollowing parts of the human body:

a. blood vessel: inserted devices contacting a point on a blood vessel oras a channel to the blood vessel system.

b. tissue/bone/dentinum: devices and materials that are inserted into thetissue, bones as well as endodontium/dentinum system.

c. blood circulation: devices that contact the blood circulation system.

5.Implantables: devices that are entirely or partly inserted into thecavity or tract of the human body by surgery. These devices either remain inthe body over a long period of time, or partly remain in the body for at least30 days.

6. Active device: any medical device that operates on electric power orother forms of energy excluding those directly generated by human body orgravity.

7. Reusable surgical instruments: devices that are used to conduct suchprocedures during a surgery as excision, boring, sawing, clutching, scraping,clipping, drawing and clamping without having to resort to any active deviceand that can be reused after certain treatment.

8.Central Circulation System: referring to a number of vessels of theblood circulation system including pulmonary artery, aorta, coronary artery,carotid artery, cerebral artery, cardiac vena, upper cavity vena, and lowercavity vena.

9. Central Nervous System: referring to cerebrum, meninx and medullaspinalis.

Article 9 The State Drug Administration is responsible forinterpretation of the provisions.

Article10 TheProvisions shall go into effect as of April 10, 2000.