State Drug Administration Order

Number 15

      The Provisions on the Classification of Medical Device herein released were examined and passed by the State Drug Administration on February 17th, 2000 and go into effect from April 10th, 2000.

Bureau Director: Zheng Xiaoyu

April 5th, 2000

Provisions on the Classification of Medical Device

Article 1 These provisions have been formulated in accordance with the Provisions for the Supervision and Administration of Medical Devices in order to standardize the classification of medical device.

Article 2 "Medical device" as defined by these provisions refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application, the use of which is to achieve the following intended objectives:
    1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;
    2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
    3. Investigation, replacement or modification for anatomy or a physiological process;
    4. Control of conception.

It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means.

Article 3 These provisions are to be used as a guide for the formulation of the List of Classifications for Medical Device and to confirm the registration classification of any new products.

Article 4 The classification of medical device should be based on a combination of three factors: its structural characteristics, the form of its use and the conditions of its use.

The List of Classifications for Medical Device (see appendix) may be used to determine the specific classification for medical device.

Article 5 The factors for determining the classification of medical device

    a. Structural characteristics

There are two categories for this factor: powered device and non-powered device.

    b. Form of use

The form of use falls into the following categories depending on the intended purpose of the devices:
   1. Forms of use for non-active medical device: for channeling or storing medicinal liquids, to effect a change in blood or other bodily liquids, to use as medical dressing, surgical device, reusable surgical device, disposable antiseptic device, implantable device, contraceptive and birth planning device; disinfecting and cleaning device, monitoring device, external diagnostic solution and any other non-active connect or auxiliary device.
   2. Forms of use for active medical device: device for energy treatment, diagnostic monitoring device, device for delivery of body liquids, ionic radiation device, laboratory instruments and device, medical disinfecting device and other electrical device or device assisted by electricity.

    c. Conditions of use

Medical device falls into two categories: device that comes in contact with the body or enters the body and device that does not come into contact with the body, depending on the possibility of bodily injury during use and the effect on treatment results.

  1) Device that makes contacts with the body or enters the body
    a. Duration of device is in use is classified as: transient use, short-term use and long-term use
    b. According to the part of the body coming in contact with the device, device is divided into: device that comes into contact with the skin or body cavity, wound or internal tissue, blood circulatory system or central nervous system.
    c. The possible degree of harm caused by electrical device out of control is classified as: slight injury, moderate injury or serious injury.
   2. Device that does not come in contact with the body

The degree of effect on treatment results is classified as: basically no effect, indirect effect or substantial effect.

Article 6 Principles for determining the classification of medical device
    a. The table for determining classification should be used to determine the classification of medical device.
    b. The classification of medical device should mainly depend on the intended purpose or effect of its use. If the intended purpose is different from the effect for the same product, the classification should be otherwise determined.
    c. If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.
   d. If a device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use.
   e. Software to control the functioning of medical device should fall in the same classification as that of the medical device.
   f. If two different classifications can apply to a medical device, the higher classification shall apply.
g. Products that monitor or affect the main functions of medical device should be classified the same as the device that they monitor or affect.
   h. State Drug Administration may revise the classification of medical device that requires special supervision and administration as required by work need.

Article 7 State Drug Administration is in charge of medical device classification. In cases where the classification cannot be determined from the List of Classifications for Medical Device, Drug Administration of the provincial level will make a pre-determination of the classification in accordance with the Provisions on the Classification of Medical Device. The pre- determination shall be sent to the State Drug Administration for confirmation.

Article 8 Definitions for the below terms used in these provisions
   1. Intended purpose: refers to the result that should be achieved by use of the medical device as specified in the product’s instructions for use, label or advertising material. Risk: possibility that use of the medical device may cause injury to human beings and severity of injury.
   2. Duration:
   3. Transient: Intended for continuous use for less than 24 hours
   4. Short-term: Intended for continuous use for between 24hours and 30 days
   5. Long-term: Intended for continuous use for more than 30 days
   6. Continuous use: The period during which the medical device actually produces an effect according to the intended purpose without stopping
   7. Parts of the body where device is used:
   8. Non-contact device: device that does not directly or indirectly come into contact with patient
   9. Surface contact device: includes device that comes into contact with the following parts of the body:
a. Skin: medical device that only comes into contact with undamaged skin.
   2. Mucosa: medical device that comes in contact with mucosa.
   3. Damaged surface: medical device that comes into contact with wounds or other breached dermis.
   3. Surgically invasive device: An invasive device which that partially or totally penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation, including devices that come into contact with the following:
a. Blood vessels: medical device that acts as a channel into the blood vessel system by piercing the blood vessel or comes into contact with some point in the blood path
   2. Tissue/bone/dentine: device and materials that invades tissue, bone or dental pulp/dentine system
   3. Blood circulation: device that comes into contact with the blood circulatory system
   5. Implantable device: Any device which is totally or partially introduced into the human body or natural body cavity by surgical intervention; intended to remain in place after the procedure for a long period of time or partially remain in place after the procedure for at least 30 days
   6. Active device: any medical device operation of which depends on a source of electrical energy or any other source of power other than that directly generated by the human body or gravity and which acts by converting this energy.
   7. Reusable surgical instruments: instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar surgical procedure without connection to any active medical device and which can be reused after appropriate procedures have been carried out.
   8. Central circulatory system: refers to pulmonary artery, aorta, coronary artery, carotid artery, cerebral artery, cardiac veins, vena cava superior and vena cava inferior involved in blood circulation.
   9. Central nervous system: refers to brain, meninges and spinal cord.

Article 9 Interpretation of these provisions is the responsibility of the SDA.

Article 10 These provisions go into effect April 10, 2000.

Appendix: List of Classifications for Medical Device

Appendix: List of Classifications for Medical Device

Skin /Cavity Opening Wound /Tissue Blood

Circulation / Central Skin/Cavity Opening Wound /Tissue Blood Circulation/Central Skin/Cavity Opening Wound /Tissue Blood Circulation/

Central 1 Liquid drug delivery and preservation device 2 2 3 2 2 3 2 3 3 2 Equipment to alter blood or other body liquids ---- ---- 3 ---- ---- 3 ---- ---- 3 3 Med. Dressing 1 2 2 1 2 2 ---- ---- ---- 4 Surgical Instruments (Inva-sive) 1 2 3 2 2 3 2 3 3 5 Reusable Surgical Instruments 1 1 2 ---- ---- ---- ---- ---- ---- 6 Disposable Aseptic Surgical Device 1 2 3 2 3 3 2 3 3 7 Implant Device ---- ---- ---- ---- ---- ---- 3 3 3 8 Contraceptive Device 2 2 3 2 3 3 3 3 3 9 Disinfect/Cleaning Device 2 2 2 2 2 2 2 2 2 10 Other Non-power Equipment 1 2 3 2 2 3 2 3 3

Notes on use of the table:
    1. This table is the appendix for the provisions on the classification of medical device. A dash (----) indicates that this category does not exist.
    2. The number or symbol in a section is the code number for the section. The codes for the parts of the body may be “1,” “2,” “3,” etc. For example, the code for some piece of surgical device which comes into contact with some tissues of the body for a short time during use and is a non-power device would be AA4-22.  

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