Medical device label: "The most familiar stranger..."

In fact, the labels of medical devices serve as an important medium for presenting information such as the safety, effectiveness, and main technical features of the devices. Failure to standardly label the devices may pose potential risks to the safety of the users, and the relevant production and operation enterprises of the devices may also be subject to penalties as a result.

Regarding the labeling requirements for medical devices, ISO has established various standards to define them, such as ISO15223-1 and ISO20417, while the FDA also has general regulations for the labeling of medical devices.

Definition of labels

All labels and other written, printed or graphic materials:

1. On any item or any container or packaging of the item;
2. At any time after the item is shipped for sale or during the transportation in interstate trade.

Label requirements for sterile instruments

• If only a part of the instrument is sterile, a warning should be indicated;
• If resterilization is not recommended, users should be reminded to pay attention;
• For instruments that need to be disinfected before use, sufficient information should be displayed.

Label requirements for over-the-counter devices

• Requirements for the main display surface;
• Identification statements;
• Declaration of the net quantity of contents.

The declaration of the net quantity of contents should include: weight, size, numerical enumeration form; or combination of numerical enumeration and weight, measurement or size.