A total of 366 medical device product classification and definition results are summarized this time, including 73 products recommended to be managed according to Class III medical devices, 148 products recommended to be managed according to Class II medical devices, 33 products recommended to be managed according to Class I medical devices, and 19 products that are recommended to define management attributes according to the judgment procedures of drug-device combination products (this part only gives preliminary suggestions for management according to the drug-device combination management, and the determination of its specific management attributes should be determined according to the relevant requirements for the definition of drug-device combination product attributes). 30 products are recommended according to the specific situation, 56 products are not recommended as medical device management, and 7 products are not recommended to be managed as medical devices alone.

The classification and definition results of the following products are based on the existing regulatory policies, the current classification catalog, based on the current scientific cognition and consensus, and based on the information provided by the applicant. The summary and publication of the classification definition results do not represent the recognition of the safety and efficacy 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 product and do not represent a complete representation of the relevant product registration or filing content. In the 'Medical Device Classification Catalogue', there is no corresponding 'classification code' of the first-level product category indicated by '00', such as the classification code of 'ophthalmic adhesives': 16-00. If there are any adjustments to the management attributes and management categories, the latest release shall prevail.

1. Products recommended to be managed according to Class III medical devices (73)

2. Products recommended to be managed according to Class II medical devices (148)

3. Products recommended to be managed according to Class I medical devices (33)

4. It is recommended to define the management attributes according to the judgment procedure of the drug and device combination product (19)

5. Recommended products according to specific circumstances (30 pieces)