The China Food and Drug Administration (CFDA) develops and administers regulations under authority granted by laws passed by State Council that apply to food, drug, cosmetics products and medical device. Labeling and packaging regulations pertaining to medical device are set forth in the <Provisions on the Administration of Manuals, Labels and Package Insert of Medical Devices>.
CFDA defines “label” as a display of written, printed, symbolic or graphic matter upon the medical device or package to identify the characteristic, safety, warning and other information of the product.
CFDA defines “manual/package insert” as a technical document formulated by device registrant or recorder and supplied to customers, including the basic safety and effectiveness information of the product and used for the guidance of correct installation, debugging, operation and maintaining.
The medical device labeling and packaging must be scientific, authentic, intact, accurate and consistent with the properties of the product. For imported medical devices, the device labeling and packaging shall be in Chinese, the foreign language can be used if necessary.