(a) the structural characteristics of medical devices
the structural characteristics of medical devices are divided into: active medical devices and passive medical devices.
(ii) medical device use form
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 time limit for the use of: 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 tissues; blood circulation system or central nervous system.
(3) The degree of damage caused by the loss of control of the active device is categorized as: minor damage; injury; serious injury.
2. Non-contact with the human body devices
The impact on the medical effect, the degree of which is divided into: basically does not affect; there is an indirect effect; there is an important effect.
Article VI Implementation of medical device classification decision-making principles
(1) Implementation of medical device classification shall 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, 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 Catalog" 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:
(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 risk of injury to the human body and the severity of the injury.
(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 devices that come into contact with the following parts:
(1) skin: only contact with the surface of the skin is undamaged;
(2) mucous membranes: mucous membranes in contact with the device;
(3) damaged surfaces: only contact with the surface of the skin;
(4) the use of parts of the device:
5. the use of the device: the use of the device to prevent the patient from being injured. 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/dentine 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, enter, in whole or in part, into the human body or into a natural cavity; that remain in the body for a long period of time after the surgical procedure has been completed, or that are partially retained in the body for a period of at least 30 days or more, 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, spinal cord.