What class of medical device does a disposable medical drape belong to?
Nov 15, 2025
Source: Cainiu Health
Dr. Yang Ziqi
Introduction
If medical pads are intended solely for daily care, such as absorbing small amounts of secretions and maintaining dry skin, without any special therapeutic or medical function, and if the product has a simple structure and low risk, they are typically classified as Class I medical devices. Their production and management should comply with the relevant regulations for Class I medical devices, and product registration备案 must be completed prior to market entry.
Generally, medical underpads are classified as Class I or Class II medical devices depending on their intended use and risk level. The specific classification should be determined based on the product's purpose. If in doubt, it is recommended to consult relevant regulatory authorities or professionals in advance. Detailed analysis is as follows:
If a medical underpad is used solely for routine care—such as absorbing minor secretions or maintaining dry skin—without any specific therapeutic function, and if its design is simple and poses low risk, it is typically categorized as a Class I medical device. Manufacturing and management of such products must comply with regulations for Class I medical devices, and product filing is required before market entry.
If a medical underpad is intended for specific clinical applications—such as postoperative wound care, contact with damaged skin or mucous membranes—and requires certain protective properties or adjunctive therapeutic functions, thus posing a relatively higher risk, it is generally classified as a Class II medical device. Such products require pre-market registration and must be manufactured in compliance with stricter quality control standards.
When purchasing medical underpads, choose products sold through正规 channels that carry a medical device registration number or filing certificate. Always review the product instructions to confirm the intended use.
