(Bureau Decree No. 15)
Article 1 In order to standardize the classification of medical devices, according to the "Regulations for the Supervision and Administration of Medical Devices", the formulation of these rules.
Article 2 Medical devices are: instruments, equipment, appliances, materials or other items used in the human body alone or in combination, including the required software. The purpose of its use is:
(a) the prevention, diagnosis, treatment, monitoring or alleviation of disease.
(ii) Diagnosis, treatment, guardianship, mitigation or compensation for injury or disability.
(iii) The study, substitution, or regulation of anatomical or physiological processes.
(iv) Pregnancy control.
Their use on the human body surface and in the body is not obtained by pharmacological, immunological or metabolic means, but these means may be involved and play a supporting role.
Article 3 These rules are used to guide the development of the Classification Catalog of Medical Devices and to determine new product registration categories.
Article IV to determine the classification of medical devices, should be based on the structural characteristics of medical devices, medical devices used in the form of medical devices and medical devices used in the situation of the three aspects of a comprehensive determination.
The specific determination of the classification of medical devices can be based on the "Medical Device Classification Determination Table" (see Annex).
Article V Classification of medical devices to determine the basis
(a) the structural characteristics of medical devices
structural characteristics of medical devices are divided into: active medical devices and passive medical devices.
(ii) Forms of use of medical devices
Based on different intended purposes, medical devices are categorized into certain forms of use. Among them:
1. The use of passive devices in the form of: drug delivery and preservation devices; change blood, body fluids devices; medical dressings; surgical instruments; reuse surgical instruments; disposable sterile devices; implantable devices; contraception and family planning devices; disinfection and cleaning devices; nursing devices, in vitro diagnostic reagents, other passive contact or passive auxiliary devices.
2. Active devices are used in the form of: energy therapy devices; diagnostic and monitoring devices; delivery of body fluids devices; ionizing radiation devices; laboratory instruments and equipment, medical disinfection equipment; other active devices or active auxiliary equipment.
(C) the use of medical devices
Based on the use of the possibility of damage to the human body, the impact on the medical effect, the use of medical devices can be divided into contact with or into the human body devices and non-contact human body devices, can be divided into:
1. contact with or into the human body devices
(1) the use of the time limit is divided into: temporary use; short-term use; long-term use. ; long-term use.
(2) The site of contact with the human body is divided into: skin or cavity; trauma or body tissue; blood circulation system or central nervous system.
(3) The degree of damage caused by the loss of control of the active device is divided into: minor injury; injury; serious injury .
2. Non-contact human body devices
The impact on the medical effect, the degree of which is divided into: basically no effect; there is an indirect effect; there is an important effect.
Article VI Implementation of the principles of medical device classification
(1) The implementation of medical device classification should be based on the classification decision table.
(2) medical device classification judgment is mainly based on its intended purpose of use and role. The same product if the purpose of use and role of different ways, the classification should be determined separately.
(C) and other medical devices used in conjunction with the medical device should be classified separately; medical device accessories classification should be separated from its supporting host, according to the annexes are classified separately.
(D) role in several parts of the human body, medical devices, according to the high risk of the form of use, the use of state classification.
(E) control the function of the medical device software and the medical device is classified according to the same category.
(vi) If a medical device can apply two classifications, the highest classification should be taken.
(vii) Products that monitor or influence the primary function of a medical device are classified in the same category as the monitored and influenced device.
(viii) State Drug Administration in accordance with the needs of the work of the need for specialized supervision and management of medical devices can be adjusted to its classification.
Article VII of the State Drug Administration in charge of medical device classification. According to the "Classification of Medical Devices" can not determine the classification of medical devices, by the provincial drug supervision and management departments in accordance with the "Rules for the Classification of Medical Devices" for pre-categorization, and reported to the State Drug Administration for approval.
Article VIII of these rules the meaning of the following terms are:
(a) the intended purpose: refers to the product description, labeling or promotional materials contained in the use of medical devices should be achieved.
(b) Risk: the possibility of the occurrence of the danger of causing harm to the human body and the severity of the harm.
(C) the duration of use:
1. temporary: the device is expected to be used continuously for less than 24 hours;
2. short-term: the device is expected to be used continuously for more than 24 hours within 30 days;
3. long-term: the device is expected to be used continuously for more than 30 days;
4. continuous use of the time: the device according to the intended purpose, the time during which the effect actually occurs without interruption.
(D) the use of parts and devices:
1. non-contact devices: devices that do not directly or indirectly contact the patient;
2. surface contact devices: including the following parts of the contact with the device:
(1) skin: only contact with the undamaged skin surface of the device;
(2) mucous membranes: mucous membranes in contact with the device;
(3) damaged surface: only contact with the surface of the device;
(4) the use of the device: the use of the device in accordance with the intended purpose of the actual action without interruption. p>(3) Injured surfaces: instruments that come into contact with wounds or other injured body surfaces.
3. Surgical invasive instruments: with the aid of surgical procedures, instruments that invade the body, in whole or in part, through the surface of the body, and the contact includes the following parts of the instrument:
(1) vascular: invasion of blood vessels in contact with a point on the blood path; as a conduit to the vascular system into the instrument;
(2) tissue / bone / dental: invasion of tissue, bone and dental pulp / dental system of instruments and materials;
(3) Circulation: instruments that contact the circulatory system.
(5) Implanted instruments: any instruments that, with the aid of a surgical procedure, are introduced in whole or in part into the human body or a natural cavity; that remain in the body for a prolonged period of time after the surgical procedure has been completed, or that are partially retained in the body for at least 30 days, are considered implanted instruments.
(vi) Active device: any medical device that relies on electrical or other energy sources other than those generated directly by the human body or gravity to perform its function.
(vii) Reusable Surgical Instrument: an instrument that is used in surgery to perform cutting, slashing, drilling, sawing, grasping, scraping, pincering, extracting, clamping, or similar surgical procedures, is not connected to any active instrument, and can be reused through certain processing.
(viii) Central circulatory system: the pulmonary artery, aorta, coronary arteries, carotid arteries, cerebral arteries, cardiac veins, superior vena cava, and inferior vena cava of the human blood circulation.
(ix) Central nervous system: refers to the brain, meninges, and spinal cord.
Article IX These rules shall be interpreted by the State Drug Administration.
Article X These rules shall be implemented from April 10, 2000 onwards.
Attachment: Medical Device Classification Judgment Table
Attachment: Medical Device Classification Judgment Table
Contact or access to the human body Device A
Powered device A form of use Temporary use - 1 Short-term use - 2 Long-term use - 3
Skin/lumen Trauma / Tissue Blood Circulation / Center Skin / Lumen Trauma / Tissue Blood Circulation / Center Skin / Lumen Trauma / Tissue Blood Circulation / Center Skin Skin/lumen Trauma/tissue Blood circulation/center
1 Drug delivery and preservation devices 2 2 3 2 2 3 2 3 3 3 3
2 Devices for altering blood fluids - - 3 - 3 - 3 - 3 - 3 - 3
3 Medical dressings 1 2 2 1 2 2 - - - -
4 Surgical instruments (invasive) 1 2 3 2 2 3 2 3 3 3
5 Reusable surgical instruments 1 1 2 - - - - - -
5 Surgical instruments for reuse 1 1 2 - - - - - - - -
1 Medication delivery and preservation instruments
Active Devices B Forms of Use Minor Injury -1 Injury -2 Severe Injury -3
1 Energy Therapy Devices 2 2 3
2 Diagnostic Monitoring Devices 2 2 3
3 Body Fluid Delivery Devices 2 3 3
4 Ionizing Radiation Devices 2 3 3
5 Other General Active Devices 2 2 -
Non-contact Human Devices B
Passive Devices A Forms of Use Substantially No Impact -1 Indirect Impact -2 Indirectly Significant Impact -3
1 Nursing Care Devices 1 2 -
2 In Vitro Diagnostic Reagents 1 2 3
3 Other Assistive Devices 1 2 -
Active Devices B Forms of Use Substantial No Impact -1 Indirect Impact -2 Indirect Significant Impact -3
1 Laboratory Instrumentation 1 2 -
2 Sterilization Equipment 1 2 -
3 Other Auxiliary Devices 1 2 -
Description of Use:
1. This table is used as an annex to the rules for the classification of medical devices for the classification of specific products. The symbol "-" in the table indicates that there is no such classification.
2. The numbers or symbols in the title column are the code names of this column. The code of the human body parts are available in order: "1", "2", "3" and so on. For example: a passive short-term contact tissue surgical invasive device code name: AA4-22.