Medical devices- Definition and Classification

Medical devices- Definition and Classification


Medical devices has different definitions in different countries but Medical devices is generally referred to as any device and equipment provided by a human manufacturer for the purpose of prevention diagnosis treatment or reduction of pain. All devices and devices that are in good health are in the Medical devices group. In today's world the diversity of Medical devices groups is huge and each has a different application. But in general Medical devices can be categorized into three general categories of prevention diagnosis and treatment.  

Classification of medical devices

The Food and Drug Administration (FDA) has grouped out a list of 1 700 types of Medical devices in 16 medical specialties each of which with regard to safety and effectiveness falls into one of the following three categories:

Class 1 or A

Class 1 are goods that have at least legal control. The level of impact and risk of these devices is minimal on people and they are simpler than other classroom products. For such goods there should be "general controls". General Contains:

  1. Registration and specifications of the manufacturer distributor re-packagers and companies that make changes to the device's symptoms in the US Food and Drug Administration
  2. Register a product that is ready for sale at the US Food and Drug Administration
  3. Production of the device in accordance with the principles of "good production conditions"
  4. Labeling the device according to the rules
  5. Pre-sale announcement if the device is not released from pre-sale announcement

47% of the Medical devices is in this class and 74% of the equipment does not need to provide pre-sale announcements and they are also called 'reserved facilities'. Bandages plastic handkerchiefs and regular scales are in this category.  

Class 2 or B

Class 2 are goods that are not only "general controls" to ensure their quality is not enough and some special controls should be made on them. Few of these devices are exempted from pre-sale notice. These special controls may include special labeling requirements performance standards and after-sales monitoring. Items like a hot water bottle and in some countries mats are placed in this category.  

Class 3 or C

The most sensitive devices with hard-facing controls are in this category. In this category there are goods that the patient's life depends on their proper functioning. These devices have a huge impact on the diagnosis control or treatment of the disease. These tools do not need to be announced before they are sold. The quality assurance of these products is not met with general controls and requires a lot of scientific experiments and research. Items like a barometer a thermometer a heart rate monitor and advanced hospital equipment in this group.