What's Medical device products in the category management category 123?

Medical device products in the category management category 123 category What do you mean, respectively,

Medical device classification rules

The first category to regulate medical devices, according to "Supervision and Regulation of Medical Devices", the enactment of this rule.

The second refers to medical devices: the human body alone or in combination with instruments, equipment, apparatus, material or other
Items, including the necessary software. Purpose of use is:
(A) disease prevention, diagnosis, treatment, monitoring or mitigation.
(B) injury or disability of the diagnosis, treatment, monitoring, mitigation or compensation.
(C) of the anatomical or physiological process of investigation, replacement or adjustment.
(D) of pregnancy control.
For the human body by its not the role of pharmacology, immunology or metabolic means, but it may have this
Some means to participate and play a supporting role.

Article III of the Rules for guidance, "medical device category," the formulation and identification of new product registration category.

Classification of medical devices as defined in Article IV, should be based on structural characteristics of medical devices, medical equipment and medical devices used in the form
Mechanical status of the three aspects of the use of a comprehensive decision.
Determine the specific medical devices can be classified according to "medical device classification decision table" (see annex).

Article Criteria of Medical Device Classification
(A) structural characteristics of medical devices
Structural characteristics of medical devices are divided into: active and passive medical equipment medical equipment.
(B) the form of medical devices
Depending on the intended purpose, the use of medical devices classified as a certain form. Of which:
1. Passive devices use forms: liquid transportation saving devices; change in the blood, body fluids equipment; medical dressings; outside
Science instruments; re-use surgical instruments; disposable sterile instruments; implants; contraception and family planning devices; disinfection clear
Cleaning equipment; care devices, in vitro diagnostic reagents, and other passive devices such as auxiliary contact or passive.
2. Active devices use the form: energy treatment equipment; diagnostic monitoring equipment; transmission fluid device; ionizing radiation
Instruments; laboratory equipment, medical sterilization equipment; other active devices or active auxiliary equipment.
(C) the state of medical devices
According to the use of the possibility of damage to the human body, the effects of medical, medical device usage can be divided into
Contact or enter the human body equipment and non-contact equipment, concrete can be divided into:
1. Contact or enter the body Devices
(1) the use of time is divided into: temporary use; short-term use; long-term use.
(2) into contact with human body parts: skin, or cavity; trauma or body tissue; the blood circulation system or central nervous system
System.
(3) active devices out of control into the extent of damage: minor injuries; injury; serious injury.
2. Non-contact body devices
Effect on the medical, which were divided into: Basic does not affect; have indirect effects; have a major impact.

Implementation of Article VI to determine the principles of classification of medical devices
(A) the implementation of the classification of medical devices should be determined according to the classification table.
(B) Classification of medical devices according to their intended use to determine the main purpose and role. If you use the same product objective
And different mode of action, classification should be determined separately.
(C) medical devices used in conjunction with other medical devices should be classified separately; attachment classification of medical devices
Its support of the host should be separated from the case of a separate category in the Annex.
(D) role in several parts of the human body for medical devices, according to the use of high-risk form, the use of state classification.
(E) control function of medical device software and the medical devices are classified according to the same class.
(F) If a medical device can be applied to two categories, should be taken to the highest classification.
(Vii) monitor or main function of medical device products, and its classification of devices being monitored and classification.
(H) The State Drug Administration of the work requires, in need of special supervision and management of medical devices can be adjusted
The entire classification.

Article VII of the competent State Drug Administration medical device classification. Basis of "medical devices category" not
Can determine the classification of medical devices, by the provincial drug administration department under the "Medical Device Classification Rules" pre-sub-
Class, and report to the State Drug Administration approval.

Article VIII of the Rules the following terms mean:
(A) of the intended objectives: refers to the product description, label or promotional materials enumerated, the use of medical devices should be made
Use.
(B) Risk: the risk of injury caused by the occurrence of human possibility and severity of the injury.
(C) the use of period:
1. Temporary: the continuous use of equipment is expected within 24 hours of time;
2. Short-term: equipment expected within 24 hours of continuous use over time within 30 days;
3. Long-term: the continuous use of equipment is expected to more than 30 days;
4. Continuous use of time: the purpose of equipment as expected, there is no interruption to the actual role of the time.
(D) the use of parts and equipment:
1. Non-contact devices: No direct or indirect contact with the device;
2. Surface contact devices: including parts in contact with the following equipment:
(1) skin: only contact with the skin surface of the device is not damaged;
(2) mucous membranes: mucous membrane contact with the device;
(3) damage the surface: surface wound or other injury in contact with equipment.
3. Invasive surgical instruments: With surgery, instruments penetrated all or part of the body through the surface, the contact includes the following
Parts of the equipment:
(1) vascular: invasive vascular and blood on the road a point of contact; as a pipeline to the vascular system, the input device;
(2) Organizational / bone / dentine: invasive tissue, bone and pulp / dentin system, equipment and materials;
(3) blood circulation: contact with the blood circulation system equipment.
(E) implants: Any use of surgery, all or part of the access device or natural cavity in the body; in
After the surgical procedure to stay in the body, or parts of these devices remain in the body at least 30 days or more, these devices are considered
As is the implants.
(F) Active devices: any electric or other energy dependent and not directly by the energy produced by the human body or gravity to send
Play the function of medical equipment.
(G) re-use surgical instruments: refers to equipment used in surgery to cut, cut, drill, saw, grasping, scraping, clamping,
Pumping, folder, or a similar surgical procedure, not connected to any active devices, the processing by certain devices can be re-used.
(Viii) central circulatory system: refers to the human blood circulation in the pulmonary artery, aorta, coronary, carotid, cerebral
Arteries, cardiac veins, the large vena cava, inferior vena cava large.
(Ix) the central nervous system: refers to the brain, meninges, spinal cord.