Is a sterile medical pad a Class I medical device?
Nov 29, 2025
Source: Cainiu Health
Dr. Li Feng
Introduction
In general, sterile medical pads are classified as medical devices (classified under "器械字号"). Wash hands before use, and after opening the package, avoid touching the side that will contact the wound surface. Replace promptly according to the usage scenario and needs to prevent reduced effectiveness from prolonged use. Unopened products should be stored in a dry, well-ventilated area, avoiding compression and damp environments.
Generally, sterile medical drapes are classified under medical device registration (classified as "械字号"). The detailed analysis is as follows:
Sterile medical drapes are categorized as medical devices primarily because they are directly used in wound care or medical procedures. Their manufacturing process must comply with strict medical standards, with professional testing conducted from raw material selection to sterilization techniques, ensuring no microbial contamination and material safety. These products must undergo clinical validation to confirm their medical efficacy—such as protecting wounds and absorbing exudate—and their ability to reduce infection risks. These health-related characteristics necessitate their regulation within the medical device management framework.
Before use, wash your hands thoroughly. After opening the package, avoid touching the side intended to contact the wound. Replace the drape promptly according to the specific application and needs to prevent reduced effectiveness from prolonged use. Unopened products should be stored in a dry, well-ventilated area, protected from compression and moisture. If opened but not used immediately, any remaining portion must be properly sealed. Do not use if the packaging is damaged or if the product has exceeded its expiration date.
