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Instruction and labeling
撰稿：lzk更新日期：2020-10-21
The instruction for use, label and package of medical devices shall comply with requirements that are laid out in the “Regulations on the Instructions for Use, Label, and Packaging of Medical Devices (SFDA Order No. 10)”, including prohibitions on the use of certain claims and expressions relating to product efficacy, superiority, and endorsements. Under SFDA Order No. 10, the instructions for use, label, and packaging of medical devices must be in Chinese, although another language may be appended.24 Instructions for use must be submitted for review by the SFDA with the device’s registration application and may not be modified or changed without SFDA’s approval. The registration number of a medical device shall be marked on the product itself and the external package according to the provisions of the drug regulatory authority under the State Council.
For more information please contact 86-755-83997910 or email to wrr@sist.gov.cn
