The creation of any tools that will be used in the diagnosis of patients is known as Medical Device Manufacturing. An equipment can only be termed as medical equipment if it can perform the function of diagnosing sickness and at the same time help in the treatment of the patient. Similarly, the device should not, in any case, interfere with the chemical or natural metabolism of the patient for it to fall under the description of medical device. The CT scanners, x-ray machines and any other tool which is not a drug, are among the notable medical devices. Thevregulations detailing how the medical devices have to made do not currently exist. The various medical regulatory bodies have enacted some recommendation that is necessary for the medical devices manufactures to follow in order to make products that are of better quality.
Depending with the kind of medical help the medical equipment will give to the patients, they are usually subdivided into three categories. The devices in group one comprise of medical devices which are not supposed to offer any life-supporting services to the patients. Similarly, this equipment should not be able to prevent instances of human impairment that may be facing the patient. The equipment, however, should not pose any risk of causing harm or injury to the patients. The devices commonly referred to as general controls, and special controls form the second group of the medical devices. Due to the role the machines in this stage play in helping in sustaining the life of an individual, they are therefore known to be very crucial. In order to prevent the condition of the patient from deteriorating, these machines can be used. The devices classified under the general and special control group require permission to be accessed due to the high risks that they pose when used.
The general controls and premarket approval medical devices fall into the third class. The handling of devices that are found in this group brings along further threats. For any individual or organization to be permitted to use the devices in this class, they should seek the approval of the relevant body mandated to oversee the use of these devices in their countries. One should be granted permit from the top levels of authority in the medical fraternity so as to publicize the medical devices in this category. The life of an individual can be made better and at the same time severely threatened by the use of medical devices in this category.