The state on the implementation of medical equipment according to what classification management
Refer to the international classification, strictly grasp. Use risk is the basis for product classification.
State Food and Drug Administration to develop a "medical device classification rules"
Article 1
To regulate the classification of medical devices, in accordance with the "Medical Device Supervision and Management Regulations" to develop these rules.
Article 2
Medical devices are instruments, equipment, utensils, materials, or other items that are used alone or in combination with the body, including the required software. The purpose of its use is:
(A) the prevention, diagnosis, treatment, monitoring or remission of the disease.
(2) diagnosis, treatment, monitoring, remission or compensation of injury or disability.
(C) research, substitution or regulation of anatomical or physiological processes.
(D) pregnancy control.
Its use in the body surface and the role of the body is not used pharmacological, immunological or metabolic means to obtain, but there may be these means to participate and play a supporting role.
Article 3
These rules are used to guide the development of the Catalog of Medical Device Categories and to identify new product registration categories.
Article 9
These rules are interpreted by the State Drug Administration
Article 10
These Rules shall come into operation on April 10, 2000.
2, non-contact human body equipment
The impact on the medical effect, the degree is divided into: the basic does not affect; have an indirect effect; have an important impact
Article 6
The principle of judging the classification of medical devices
(A) the implementation of medical equipment classification, should be based on classification criteria table.
(2) The classification of medical devices is mainly determined according to its intended use and purpose. The same product if the use of purpose and role in different ways, classification should be judged separately.
(C) medical devices used in conjunction with other medical devices should be classified separately; medical equipment accessories should be separated from their supporting host, according to the attachment of the separate classification.
(D) the role of several parts of the body of medical equipment, according to the use of high risk forms, the use of state classification.
(5) The software that controls the function of the medical device and the medical device are classified according to the same category.
(Vi) If a medical device can be applied to two categories, the highest classification should be taken.
(7) Products that monitor or influence the main functions of medical devices, the classification of which is consistent with the classification of the equipment being monitored and affected.
(8) The State Drug Administration may adjust its classification of medical devices that need special supervision and management according to the needs of the work
