This summary of the medical device product classification definition results of a total of 226, of which 36 products are recommended to be managed in accordance with Class III medical devices, 111 products are recommended to be managed in accordance with Class II medical devices, 15 products are recommended to be managed in accordance with Class I medical devices, 17 products are recommended to be defined in accordance with the procedures for determining the management attributes of the combination of drugs and equipment products (this part only gives the initial recommendations for the management of the combination of drugs and equipment, and its (This part only gives preliminary recommendations for management by drug-device combination, and the specific management attributes should be determined according to the relevant requirements for the definition of product attributes of drug-device combination), 14 products are recommended to be determined on a case-by-case basis, and 33 products are recommended not to be managed as medical devices.

The classification and definition results of the following products are based on the existing regulatory policies, the current classification catalog, based on the current stage of scientific knowledge and consensus, based on the information provided by the applicant, and after research and synthesis. The classification and definition results published in the summary do not represent the approval of the safety and effectiveness of its products, and are only used as a reference for the registration or filing of medical device products. The product description and intended use in the results are used to determine the management attributes and categories of the products, and do not represent the complete expression of the content of the relevant product registration or filing. There is no corresponding Class I product category in the Classification Catalog of Medical Devices, and the “classification code” is indicated by “00”, for example, the classification code of “Myofascial Release Water Jet Power System” is 01-00: If the management attributes and management categories are adjusted, the latest release shall prevail.

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