Class I, Class II, and Class III medical device markings are as follows:
Medical devices are devices, appliances, equipment, materials, or other items that are used for the prevention, diagnosis, treatment, or relief of human disease, injury, or disability. Depending on the risk of the product and regulatory requirements, medical devices can be categorized into Class I, Class II and Class III.
Class I medical devices are medical devices that are sufficiently safe and effective through routine management, such as some simple medical equipment and supplies, such as medical swabs and medical tape. This type of medical device can be sold using ordinary sales channels and does not need to apply for a medical device registration certificate.
Class II medical devices are medium-risk and potentially dangerous medical devices, such as some common medical devices, such as blood pressure monitors, thermometers and so on. This type of medical device needs to pass the registration approval of the drug supervision department and obtain a medical device registration certificate before sale.
Class III medical devices are high-risk and potentially dangerous medical devices, such as some complex medical devices, such as artificial joints, pacemakers and so on. These types of medical devices are subject to the most stringent regulation and approval, and need to apply for a medical device registration certificate and undergo rigorous approval and testing by the drug supervision department.
The categorization of medical devices is based on the different risks and regulatory requirements of the products and aims to ensure the safety and effectiveness of medical devices. Different classes of medical devices are subject to different regulations and standards and require different registration and approval procedures.
The medical device registration certificate is the certificate issued by the drug supervision department after the registration and approval of the medical device, which is necessary for the medical device to be legally marketed and sold. The medical device registration certificate indicates the product's technical specifications, scope of use, manufacturer and other information, and is an important basis for the quality and management of medical devices.
Medical device standards are standards that guide and regulate the design, production, sales, use and maintenance of medical devices. Medical device standards include some standards set by national drug supervision departments and some standards set by industry associations. The production and use of medical devices must comply with the corresponding standard requirements.
The supervision of medical devices refers to the supervision and management of the whole process of research and development, production, sales and use of medical devices by the drug supervision department to ensure the safety and effectiveness of medical devices. The production and use of medical devices must comply with national laws and regulations and relevant standard requirements.
In short, the classification and management of medical devices, registration certificates, standards and supervision are all important measures to ensure the safety and effectiveness of medical devices. It is the responsibility of every medical device manufacturer and user to understand and comply with relevant regulations and standard requirements.