医疗器械说明书、标签和包装标识管理规定（Provisions on the administration of medical equipment instructions, labels and packaging marks）.doc

医疗器械说明书、标签和包装标识管理规定（Provisions on the administration of medical equipment instructions, labels and packaging marks） Provisions on the administration of medical equipment instructions, labels and packaging marks (promulgated by Decree No. tenth by the State Food and Drug Administration on July 8, 2004 and effective as of the date of promulgation) Article 1 These Regulations are formulated in accordance with the regulations on the supervision and administration of medical devices, in order to regulate the medical equipment manuals, labels and packaging marks and ensure the safety of medical devices. Article second all medical devices sold and used within the territory of the Peoples Republic of China shall, in accordance with the provisions of these regulations, be accompanied by brochures, labels and packaging marks. Products which are simple and easy to use may be omitted according to the provisions of the State Food and drug administration, one item or two items in the three items of the instruction manual, label and packaging mark, as prescribed by the State Administration of food and drug administration. Third users of medical devices should use medical instruments in accordance with the medical device instructions. Fourth medical equipment refers to the instructions made by production enterprises, and is provided with the product to the user, the product is safe and effective to cover the basic information and technical documents to guide the correct installation, commissioning, operation, use and maintenance. A medical device label is a text, description, graphic, and symbol attached to a medical device or package for identifying the characteristics of a product. Medical device packaging mark refers to the written description of the main technical characteristics of medical equipment and graphics and symbols marked on the package. The contents of fifth medical equipment manuals, labels and packaging logos shall be true, complete, accurate, scientific and consis