Medical device instructions and labeling is to reflect the basic information of the carrier of medical devices, carrying the installation, commissioning, operation, use, maintenance and repair of medical devices, user safety warnings and other information, directly related to the use of medical devices, safety and effectiveness. Therefore, to strengthen the management of medical device instructions and labels, standardize its content is to guide the rational use of medical devices, reduce the risk of using medical devices is one of the important measures. 2004 July, the former State Food and Drug Administration issued the "Medical Device Instructions, Labels and Packaging Marking Regulations" (Bureau Decree No. 10). In March this year, the newly revised Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650) was promulgated, and in accordance with the requirements of the newly revised regulations, the State Food and Drug Administration revised the original Decree No. 10 to form the Regulations for the Administration of Instructions and Labeling of Medical Devices. The new regulations refer to the international practice, the "packaging mark" and "labeling" merged into "labeling", clear medical device labeling refers to the medical device or its packaging attached to the product characteristics and indicate the safety and security of the product. It is clear that medical device labeling refers to the text description, graphics and symbols attached to the medical device or its packaging for identifying the product characteristics and indicating safety warnings and other information, avoiding the cross confusion between the terms. For the reuse of medical devices, the use of medical devices that have a destructive or negative impact on the environment and medical devices with radiation or radiation and other specific medical devices, the new regulations combined with the supervision of the actual, clear management requirements, such as reuse of medical devices should be specified in the instructions for reuse of the process, including cleaning, disinfection, packaging and sterilization methods and the number of times that can be reused or other restrictions conditions, etc., making the requirements of the manual more rigorous and detailed and targeted. The new regulations also increase the requirements for the personal use of consumers, and make it clear that medical devices used by consumers should have special instructions for safe use, which effectively guarantees the control of the risk of personal use of medical devices. For the instructions and labels used in terminology and color symbols, the new regulations have also been standardized, such as medical device instructions and labels on the name of the disease, nomenclature, diagnosis and treatment process and results of the expression, should be used in the national unity of the special vocabulary issued or standardized; unit of measurement should be consistent with the provisions of relevant national standards; medical device instructions and labels used in the symbols or identification colors should be conform to the provisions of relevant national standards, etc. The new regulations clearly stipulate that each minimum sales unit should be accompanied by a manual, and enterprises can determine the location of the manual according to the final sales status of the product sales link, which solves the problem of obtaining manuals in the actual supervision of the supervisory authorities and the use of the user. For the registered medical device registration changes, the new regulations for the instructions and labeling changes, it is clearly stipulated that the applicant to obtain the change of documents, based on the change of documents to modify the instructions and labeling, so that the requirements are more scientific and reasonable, in line with the reality. Due to the implementation of the first class of medical devices for the record management, the new regulations reflect the spirit of combination of strict and wide, the corresponding provisions are also different, such as medical devices have been filed, filing information on the table registration content, filing the technical requirements of the product as well as instructions for other changes in the content of the record, the filer can modify the instructions and labeling of the relevant content.