Who issues the registration inspection report in the documents required for the registration of Class II medical devices?

1, according to the actual characteristics of the product, relevant national standards and industry standards, and referring to the Guiding Principles for the Preparation of Technical Requirements for Medical Device Products, formulate the product technical requirements. The technical requirements of products mainly include the performance indicators and inspection methods of finished medical devices, in which performance indicators refer to the functional and safety indicators of finished products that can be objectively judged and other indicators related to quality control. There is no special standard to refer to other related standards, depending on the specific product.

2. To apply for registration inspection, the applicant shall provide relevant technical data, samples for registration inspection and product technical requirements to the inspection institution.

2. According to the Regulation on the Supervision and Administration of Medical Devices (Order No.680), the product inspection report in the application materials for the registration of Class II medical devices shall be the inspection report issued by the medical device inspection institution. The medical device inspection institution shall have the qualification of medical device inspection, conduct inspection within the inspection scope, and pre-evaluate the technical requirements of the products submitted by the applicant. The pre-assessment opinions shall be sent to the applicant together with the registration inspection report. Medical devices that are not included in the scope of medical device inspection institutions shall be inspected by qualified inspection institutions designated by the corresponding registration and examination and approval departments.