Understanding Medical Device Labeling Regulations in the US, EU and China

As medical technology advances to a point where the average human lifespan increases, it produces a world in which medical devices are more widely seen in the world. This has brought into focus the need for clear and accurate labeling on medical devices for safe use and user information. In addition, manufacturers need a way to ensure that important information reaches users quickly.

This is especially true when considering the explosion in growth of medical devices used in the home. As the population ages, it becomes more common to see medical devices used by untrained operators. In the event of a product recall, medical device manufacturers cannot merely send a recall to major hospitals, they need to contact consumers directly. This, coupled with the need for easily accessible information for use, has put pressure on manufacturers to provide a centralized registry of medical devices. 

The purpose of this white paper is to explore the current regulations for medical devices as they stand and look toward the trend for increased serialization in the medical device industry, mirroring the same regulations that currently exist for pharmaceuticals.