The difference between medical device classification levels

Medical devices have different classification levels in the domestic market to distinguish their risk levels and management requirements. These classification levels are called mechanical font sizes, including mechanical Ⅰ, mechanical Ⅱ and mechanical Ⅲ. Understanding the differences between these machine font sizes is critical for manufacturers, regulators and consumers alike. The following will introduce the differences between Machine I, Machine II and Machine III.

Device Class I: low-risk, proven devices

Class I medical devices are low-risk products. They are usually non-invasive, low-activity devices such as elastic band-aids, examination gloves, etc. The safety and effectiveness of such devices have been proven and they carry relatively low risks. Therefore, Class I medical devices generally do not require clinical trials. Manufacturers are required to provide necessary technical documents and supporting documents when registering or filing to ensure that they comply with relevant technical requirements and standards.

Device Class II: Devices with moderate risk that may require clinical evaluation

Class II medical devices are medium-risk products. They include some invasive devices and some devices with active effects, such as medical vision screening machines, infusion pumps, etc. The safety and effectiveness of such devices need to be verified through clinical evaluation. Clinical evaluation is a process of evaluating the safety and effectiveness of medical devices in actual use. In clinical evaluation, manufacturers may need to provide relevant clinical trial data and other relevant data to prove the safety and effectiveness of their products. In addition, the necessary technical documents and supporting documents shall be provided to meet the technical requirements and standards.

Device Class III: High-risk devices that may require more stringent clinical evaluation

Class III medical devices are high-risk products. These devices are often used to treat, diagnose, or monitor a serious medical condition, or are potentially life-threatening. The safety and effectiveness of Class III devices need to be verified through more rigorous clinical evaluation. Clinical evaluation includes the submission of clinical trials and other relevant data. Clinical trials are studies conducted on patients under controlled conditions to evaluate the safety and effectiveness of a medical device. Manufacturers need to provide detailed clinical trial plans, trial data and other necessary technical documents to meet relevant technical requirements and standards.

The difference in machine font size is of great significance to manufacturers, regulatory agencies and consumers. Manufacturers need to follow corresponding regulations and processes based on the characteristics and risk levels of their products to ensure product compliance and safety. Regulatory agencies will take different regulatory measures based on different levels of devices to protect public health and safety. When consumers choose and use medical devices, they should also understand the meaning of the device font size in order to make informed decisions.

In summary, there are obvious differences in risk levels, clinical evaluation requirements and management requirements between Class I, Class II and Class III medical devices. Understanding these differences is critical for all parties working with medical devices to ensure the safety and effectiveness of medical devices and protect the health and safety of the public.