In this article, let's talk about the classification of medical equipment for hospital beds. Bed is one of the most common equipment in hospitals, but many people may not know that it actually belongs to the category of medical devices. However, do hospital beds belong to Class I or Class II medical devices? Why do some hospital beds require registration and filing, while others do not? This is actually related to the function, structure, and relevant regulatory requirements of the hospital bed. Let's go into detail below.
Ordinary hospital beds belong to a category of medical equipment
Ordinary hospital beds, which are manually operated beds with simple structures and no electric function, are usually classified as Class I medical devices. According to the Classification Catalogue of Medical Devices, Class I medical devices refer to products with low risk that can be ensured to be safe and effective through routine management. For example, ordinary medical examination gloves and band aids belong to this category. Manual hospital beds do not involve complex power systems, and their main function is to provide patients with lying down and basic care, so they only need to meet basic production standards, such as material safety and structural stability.
The production and sales of this type of hospital bed are relatively simple. Enterprises only need to file with regulatory authorities, submit basic information such as product names, technical parameters, and production qualifications, without going through complex registration and approval processes. However, even ordinary hospital beds must comply with national industry standards, such as the bed size, load-bearing capacity, and other requirements mentioned in the draft for comments on "Manual Hospital Beds".
Electric hospital beds belong to Class II medical devices
If the hospital bed has electric functions, such as automatic adjustment of the height of the backboard and leg board, or electric driven movement function, then its risk level will be increased. According to the Classification Catalogue of Medical Devices, this type of electric hospital bed belongs to the second category of medical devices, which requires control over its safety and effectiveness.
The registration process for Class II medical devices is much stricter than that for Class I. Enterprises need to submit detailed information to provincial drug regulatory departments, including product technical requirements, clinical evaluation reports, risk analysis documents, etc. For example, the registration materials for electric hospital beds must specify the product's structural composition (such as bed frame, drive components, control module), intended use (applicable to which patient groups), and provide electrical safety and electromagnetic compatibility testing reports. In addition, if the enterprise entrusts other manufacturers to produce, it also needs to provide additional production qualification certificates from the entrusted party.
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