Medical devices are typically classified into three classes based on the risk associated with them. This classification was originally provided by the US Food and Drug Administration (US FDA), and similar classifications are followed by major Asian countries such as Japan and China.
These classifications signify the level of control required to ensure the safety and effectiveness of the device. Consequently, manufacturers of the different classes need to adhere to different levels of regulations and norms, i.e., stringent regulations for higher class of medical devices.
Medical devices can be broadly divided into medical consumables and medical equipment. The products in these categories range from consumables such as surgical gloves to high-end imaging equipment such as Magnetic Resonance Imaging (MRI) machines.
Medical devices may also be categorized on the basis of their core function. Some of these functions are as follows: Diagnostic equipment: Medical imaging machines to aid diagnosis – ultrasound, MRI, CAT-scans, PET, and X-ray machines Therapeutic equipment: Infusion pumps, medical lasers, and LASIK surgical machines. To maintain a patient’s bodily functions – medical ventilators, heart-lung machines, ECMO, and dialysis machines Medical monitors: To measure a patient’s medical state, such as vital signs, ECG, EEG, blood pressure, and dissolved gases in the blood Medical laboratory equipment: Blood, urine, and gene analyzers.