The opinions on the issuance and supplement of device products mainly involve the following aspects
1. Some product research materials are not provided or incomplete: This is the most common supplementary opinion, including the lack of all application materials in a certain aspect, or the lack of expression of key contents in a certain material. Specific opinions, such as no clear description of product application scope and product structure composition, no clear distinction between models and specifications, no clear function of components and characteristics different from other similar products, no clear determination basis and theoretical basis of relevant performance indicators, no statement on software version naming rules, etc., and no typical model statement of tested models, Failed to submit packaging verification data, etc. In addition, some of the application materials provided by the applicant are in foreign languages, and there is no Chinese version.
2. The application materials do not meet the requirements of normative documents: if the product technical requirements do not meet the guiding principles for the preparation of technical requirements for medical devices, the submitted instructions do not contain the contents required by Article 10 of the regulations on the administration of instructions and labels for medical devices, and the relevant materials required by the guiding principles for the technical review of medical device software registration are not submitted, Relevant materials required by the guiding principles for technical review of network security registration of medical devices and product biocompatibility research materials were not submitted.
3. The description of product information is inconsistent in multiple data: for example, classification code, model and specification, scope of application, production address, etc. are inconsistent in research data, test report and clinical evaluation data. In particular, there are many problems related to the production address. For example, it is impossible to judge whether the sample production address is the declared production address, the declared production address is inconsistent with the address in the submitted plant lease contract or manual, and the time of product verification data is earlier than the time of house lease at the production address.
4. Common problems of management category and registration unit: if the enterprise does not confirm whether the declared products belong to medical devices, does not specify whether the declared products are managed according to class II medical devices, or does not provide classification basis. In terms of registration units, if there are large differences between multiple models and specifications, the failure of the enterprise to submit can be used as the reason for the same registration unit.
5. Problems in the inspection report: if the registered inspection report does not contain all the contents to be tested in the product technical requirements, the GB 9706.15, YY 0709 and other standards in the declaration of conformity have not been tested, the product technical requirements adopt national standards, but the cover of the report is not stamped with the qualification identification mark CMA seal, and there is no declaration of inspection ability.
6. Clinical evaluation data: first, path selection. For example, the declared product does not belong to the catalogue of in vitro diagnostic reagents exempted from clinical trials or the information provided by the enterprise is not enough to make a judgment. The declared product belongs to the catalogue of medical devices exempted from clinical trials. Second, problems related to products of the same variety, such as improper selection of products of the same variety, failure to provide authorization documents for the use of non-public materials of products of the same variety, or inability to judge whether the supporting materials provided belong to devices of the same variety.
In vitro diagnostic reagent product supplement opinions
It mainly involves the following aspects:
1. Some product research data are not provided or incomplete: for example, the main production process is incomplete, the preparation method of calibration products is unclear, the traceability data of calibration products, the assignment data of quality control products, the complete reference interval research data, the relevant marketing situation of similar products, and the test basis sealed by the testing organization are not submitted.
2. Clinical evaluation data: if there is a difference between the declared product and the description in the catalogue of in vitro diagnostic reagents exempted from clinical trials, the clinical trial data of the declared product shall be supplemented.