Rules for Classification of Medical Devices 

CFDA Order No.15 2015

Rules for Classification of Medical Devices 

CFDA Order No.15 2015

Rules for Classification of Medical Devices 

CFDA Order No.15 2015

Article 1

The provisions are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices, with a view to standardize the classification of medical devices.

Article 2

The Provisions are meant to direct the formulation of The Category of Medical Device Classification as well as to determine the classification of newly registered products.

Article 3

The meaning of the term in the provision:

1.  Intended use:

Intended use refers to the effect which is set out in the instruction, label or promotional material, obtained by using this medical device.

2.  Passive devices:

Medical device does not rely on electric power or other forms of energy to work. But it can works by those energy which is generated by human body or gravity.

3.  Active devices:

Medical device must operate on electric power or other forms of energy excluding those directly generated by human body or gravity.

4.  Invasion instruments:

Medical devices are entirely or partly inserted into the body through the surface of body by surgery, and contact inner tissues, blood circulation system, central nervous system, etc. They include equipments which used in interventional operation, disposable asepsis surgical instruments and equipments which remain in the body for temporary or short-term. Reusable surgical instruments are not included.

5.  Reusable surgical instruments:

Devices are used to conduct such procedures during a surgery as excision, boring, sawing, clutching, scraping, clipping, drawing and clamping without having to resort to any active device and that can be reused after certain treatment.

6.  Implantable devices:

Devices are entirely or partly inserted into the cavity or tract of the human body by surgery, or used to replace the surface of epidermis or eyes of human body; these devices either remain in the body over a long period of time, or partly remain in the body for at least 30 days.

7.  Contacting devices:

Medical devices can contact human body directly or indirectly, or can be entered into human body.

8.  Using time

    8.1  Time for consecutive use: the actual working time of a device without any stop in accordance with its intended purpose.

    8.2  Temporary use: the intended term for consecutive use of the device is within 24 hours.

    8.3  Short-term use: the intended term for consecutive use of the device ranges from 24 hours to 30 days.

    8.4  Long-term use: the intended term for consecutive use of the device is more than 30 days.

9.  Skin:

The surface of the unwounded skin

10.  Cavity (mouth):

Natural orifice of human such as oral cavity, nasal cavity, esophagus, external auditory canal, rectum, vagina, urethra and so on, and perpetual artificial opening.

11.  Trauma:

The organizational structure integrity is destroyed or function is disordered caused by all inducing factors;

12.  Body tissue:

The inner tissues of human body, includes bones, endodontium or deitine, does not include blood circulation system and central circulation system.

13.  Blood circulation system:

Heart and blood vessel (except capillaries)

14.  Central nervous system

Brain and spinal cord

15.  Independent software:

Independent software refers to the software which runs on the computing platforms has one or more intended use, and can complete its expected purposes without hardware of medical devices. 

16.  Medical devices with measurement and testing function

The medical devices are used to measure parameters of physiology, pathology and anatomy, or quantitative measure the energy and substance what entered and left the body. The measure results shall be quantified, and the accuracy of results will make obvious influence on patients’ safety and health.

17.  Chronic wound

Chronic wound chronically caused by all kind reasons. Such as venous ulcer, aortic ulcer, diabetic ulcer, traumatic ulceration, pressure ulcer and so on.

Article 4

According with the degree of risk, medical devices management is classified as Class I, class II, class III.

The degree of risk is evaluated base on the intended use, structure features, use methods and forms, whether contact with human body or not, and other factors in comprehensively.

Article 5

Medical devices are divided into the following forms of operation according with the factors which impact the degree of risk.

1.  According to the structural characteristics, the medical devices are divided into passive devices and active devices.

2.  According to the factor whether contact with human body or not: the medical devices are divided into contacting devices and non- contacting devices.

3.  According to the structural characteristics and the factor whether contact with human body or not: the use forms of medical devices include:

Passive contacting devices: transportation pharmaceutical liquid, device for alteration of blood, ordinary medical dressing, surgical invasion instruments, reusable surgical instruments, disposable aseptic device, implantable device, device for contraception and birth control, as well as other passive contacting devices.

Passive non-contacting devices: patient care device, device for sterilization and cleaning, as well as other passive non-contacting devices.

Active contacting devices: devices for treatment through energy, diagnostic monitoring devices, body fluids transportation devices, ionized radiation devices, active implant devices, as well as other active contacting devices.

Active non-contacting devices: instruments for clinical detection, independent software, device for sterilization and cleaning, as well as other active non-contacting devices.

4.  Based on the different structural characteristics, the factor whether contact with human body or not, the use forms and other conditions include following situations:

Passive contacting devices: based on use time, the medical devices are divided into temporary use, short-term use, long-term use. The contacting sites are divided into skin and cavity (mouth), trauma or body tissue, blood circulation system or central nervous system.

Passive non-contacting devices: based on their impact on the medical treatment, the medical devices are divided into basically no impact, indirect impact, substantial impact.

Active contacting devices: based on the degree of injuries caused by malfunction, he medical devices are divided into minor injuries, injuries, serious injuries.

Active non-contacting devices: based on their impact on the medical treatment, the medical devices are divided into basically no impact, indirect impact, substantial impact.

Article 6

The classification of medical devices should be conducted in accordance with The Criteria for Medical Device Classification (attached list). The following principles can be combined with in classification:

1.  If one medical device pertains to two classes or more at the same time, the higher one is adopted. Medical devices package which consists of several medical devices, its classification is consistent with the medical device whose classification is the highest in the package.

2.  Accessories to medical devices should be classified based on the comprehensive consideration of its effect on the safety and effectiveness of the main body medical devices. If accessories have important influence on the main body medical devices, then the classification lever of the accessories shall not be lower than the main body medical devices.

3.  Those products that are designed to monitor or affect the major functions of a medical device should be designated to the same class of the device being monitored or affected.

4.  The drug and device combination product whose function based on the device shall be managed as Class III.

5.  The medical devices which can be absorbed by the body shall be managed as Class III.

6.  Active contacting devices which make important influence on treatment shall be managed as Class III.

7.  Medical dressing will be managed as Class III if they confirm with the following situation. Including use for anti-adhesion, artificial skin, the wound which is in the deep dermis or under it, chronic wound, or absorbed completely or partially.

8.  The medical device which is supplied sterile shall not be class lower than Class II.

9.  The orthopedic instruments can dynamical adjust appointed place of member by tension, distraction, tortion, grip pressure, bend and so on though apply an acting force on the body (but not the medical device whose functions are fixation and supporting only, and the temporary orthopaedic medical devices which is used in operation or limbs orthopaedic medical devices which is used in or after operation) shall not be class lower than Class II.

10.  Medical devices with measurement and testing function shall not be class lower than Class II.

11.  If the intended use of medical device is used to treat a disease, then the medical device shall not be class lower than Class II.

12.  The Passive reusable surgical instruments which are used to take out, cut up the tissues or take stone and so on shall be managed as Class II.

Article 7

In vitro diagnostic reagent shall be classed according to relevant regulations.

Article 8

The State Food and Drug Administration shall analyze and evaluate risk changes of products and readjust the classification of certain medical devices based on its production, distribution, use.

Article 9

State Food and Drug Administration can formulate and adjust the catalogue of the medical device classification by organizing expert committees of medical device classification.

Article 10

These provisions shall put in force from Jan 1, 2016, also abolish the Provisions for Medical Device Classification promulgated on Apr 5, 2000 (the former State Food and Drug Administration decree No.15) shall be repealed simultaneously.

Attachment: Decision table of medical device classification

 

 

Attachment

Decision Tables of Medical Classification

NOTE: “1, 2, 3” in the table stand for Class I, Class II, Class III medical device, respectively.

       “—”in the table stand for inexistence.