China specific local type testing requirements for IVD, passive and active devices.
Medical electronic instruments involve data transmission. For example, temperature data can be transmitted through WIFI (without patient information). Is it necessary to add “network security” performance indicators and inspection methods according to the software technical review guidelines?
It is now basically clear that if medical electronic instruments (i.e. hardware) have the function of transmitting data externally, in specific forms such as USB, RS232, WIFI Bluetooth, etc., they need to be inspected in accordance with the corresponding indicators described in the “Guiding Principles for Medical Device Network Security Technical Review” should be formulated based on the actual situation.
When an active product changes and a new model is added, is it necessary to conduct testing?
If the registrant wants to apply for a change in registration to add a product model, he should first confirm whether the model being applied for and the original model can be used as the same registration unit. Only if they belong can he apply for change and addition. In the absence of new mandatory standards, the judgment should be based on the principle of typical model determination. If the original model can represent a new model, there is no need to inspect the new model; if the inspection report of the original model If some of the items can represent new models, this part does not need to be inspected repeatedly. For other items not covered, an inspection report for the new model should be provided. If a new mandatory standard is involved, an inspection report showing that the new model can comply with the new standard needs to be provided. If the original model can represent the new model, an inspection report proving that the original model meets the new standard can also be submitted.
After the product is registered and submitted for inspection, but before the registration certificate is issued, if the design of the product changes, what should be done?
If a registered inspection report is not obtained and the product undergoes major changes in design, structure or performance parameters, it should be submitted for inspection again as a new product, and the original inspection business and inspection tasks are recommended to be terminated. Assuming that a registered inspection report has been obtained and the design, structure or performance of the product changes, it should be submitted for inspection as an independent business; if the change does not affect the structure and performance of the product, a change in specification model can be reported.
If the key components are from two different manufacturers (such as transformers), do they need to send the transformers separately for inspection or do they need to assemble the finished products separately and then send them for inspection?
If the key components are at the same location and used from two different manufacturers, in principle, one product can be submitted for inspection, and then the two key components are installed on the equipment for EMC assessment respectively, but this may involve some or all of the project requirements. It is generally not recommended to conduct repeated testing, and of course, specific analysis of specific circumstances is required.
Should changes to key components be subject to change filing or change registration? How to evaluate and choose the path?
The change of key components mainly depends on whether it causes changes in the electrical structure, such as changing the power cord and changing the supplier of fuses. These will not cause changes in the electrical structure and only require a change filing. If there are changes in the electrical structure, such as the replacement of transformers and switching power supplies, which are directly related to the degree of protection of electrical isolation, a change registration inspection should be performed at this time.
What is the significance of formulating the chemical properties of products according to product technical requirements?
By testing chemical performance indicators, producers can check raw materials, control various additives added during the production process, improve the structural composition of the product, and improve the production process. Other relevant parties can also intuitively and quickly evaluate and monitor products through chemical performance indicators. Therefore, product technical requirements should consider and improve the formulation of chemical properties.
Are there any industry standards or national standards for the accuracy testing methods of calibrators and quality control products?
For the performance indicators of quality control products, it is recommended to refer to YY/T 1652-2019 General Technical Requirements for Quality Control Materials for In Vitro Diagnostic Reagents or YY/T 1662-2019 Quality Control Materials for Biochemical Analyzers. For suggestions on formulating the performance of calibrators, refer to YY/T 1549-2017 Technical Guidelines for Research on Calibrants and Quality Control Materials for Biochemical Analyzers or In Vitro Diagnostic Reagents.
In the absence of international/national standards, industry standards and working calibration products, and there are no products of the same type on the market, how should product accuracy indicators be established?
Comparison or recovery detection methods can be used.
How to determine product performance indicators when there are no relevant standards?
Technical requirement indicators shall first refer to special standards and corresponding technical guiding principles, followed by similar standards, guiding principles and certified similar products, and then self-formulate and select general standards for large categories of methodologies. The specific performance range limits in the technical requirements are related to the performance of the product. You can refer to the series of EP documents to formulate and verify indicators for precision performance, linear performance, precision performance, clinical biochemical interference, etc. C2J-A2 biological reference interval Definition and determination, definition and determination of C28-A3 medical laboratory reference interval, etc. .
