What are the requirements for medical device instructions, labels and packaging identification?
Manuals, labels and package marks of medical devices must be used Chinese text, can be attached to other languages. The use of Chinese shall conform to the language norms commonly used by the state.
A medical device has the name of the commodity, and the name of the commodity may be marked at the same time in the instructions, labels and packaging labels, but it shall be in conformity with the commodity name marked in the registration certificate of the medical device. At the same time the product name and the name of the commodity, should not write, branch, and medical device product name text not greater than two times the product name text. No absolute term for exaggerating or asserting the efficacy of a product shall be used in the commodity name of a medical device, nor shall it be contrary to the provisions of other laws or regulations.
The product name of the medical device shall be clearly marked in the prominent position of the instructions, labels and packaging marks, and shall be in accordance with the product name in the registration certificate of the medical device.
