If the manufacturer has carried out risk management according to YY/T0316 “Application of Medical Device Risk Management for Medical Devices”, can its risk management documents directly meet the risk management requirements of GB9706.1-2020?
YY/T0316 provides a process for identifying hazards (sources) associated with medical devices, estimating and evaluating associated risks, controlling those risks, and monitoring the effectiveness of controls. YY/T0316 provides a framework for manufacturers to manage risks associated with medical devices. It does not specify a specific hazard (source) or hazard situation or an acceptable level of risk.
GB9706.1-2020 not only stipulates that the risk management process shall meet the relevant requirements of YY/T0316, but also requires the risk management process to determine whether the standard requirements take into account all hazards (sources) of ME equipment or system; How particular tests are applied to particular ME devices or systems; When there are no specific acceptable criteria for a specific hazard (source) or hazard situation, the acceptable level of risk should be established and the remaining risk should be evaluated; the acceptability of alternative risk control strategies should be evaluated.
Therefore, if the manufacturer carries out risk management in accordance with YY/T0316 “Application of Medical Device Risk Management for Medical Devices”, it does not mean that its risk management documents directly meet the requirements of GB9706.1-2020 for risk management, and it needs to be further checked according to the requirements of GB9706.1-2020.
How does the manufacturer determine the basic performance of the device?
First of all, the manufacturer needs to confirm whether the equipment has applicable special safety standards. If there are applicable special safety standards, the manufacturer needs to check whether the special safety standards specify the basic performance. If the special safety standards specify the basic performance for this type of equipment, the basic performance identified by the manufacturer should at least include the basic performance specified in the special safety standards. In addition to the basic performance specified in the specific safety standard, the manufacturer can identify more basic performance through the risk management process.
If no specific safety standard applies to the equipment, or the basic performance is not specified in the specific safety standard, the manufacturer determines through the risk management process which performance is the basic performance or determines that the equipment does not have the basic performance. Basic performance: The performance of clinical functions not related to basic safety, the loss or reduction of which would result in unacceptable risk more than the manufacturer’s prescribed limits.
Under what circumstances does it not need to provide key component data?
If the failure of any component of the equipment does not lead to a dangerous situation, it is considered that there is no key component in the equipment, and therefore it is not necessary to provide the key component information.
When is it not necessary to provide documentation for programmable Medical Electrical systems (PEMS)?
If the programmable medical electrical system (PEMS) is not expected to be connected to the IT- network, and the programmable electronic subsystem (PESS) does not provide the functions or risk management necessary for basic safety or performance to indicate that the failure of any PESS does not pose an unacceptable risk, then the requirements in Chapter 14 of GB9706.1-2020 do not apply, in which case the manufacturer does not need to provide programmable medical electrical system (PEMS) documentation during testing.
If the certificate and specifications of the switching power supply are already provided, do you need to provide the test report of the switching power supply?
Sometimes the certificate and specification of switching power supply cannot provide the required information in the testing process, while the testing report of switching power supply can supplement the information not reflected in the certificate and specification. If the manufacturer can provide the testing report of switching power supply, the communication time between the equipment manufacturer and the switching power supplier in the testing process can be effectively reduced. In order to speed up the process of detection.
If the lithium battery meets the requirements of GB31241, is it also required to meet the requirements of GB/T 28164?
The lithium battery must meet the requirements of GB/T 28164, which is the minimum requirement specified in GB9706.1-2020. Therefore, the lithium battery must meet the requirements specified in GB9706.1-2020 regardless of whether the lithium battery meets the requirements of GB31241 or other lithium battery standards (such as the UL standard).
In addition, the lithium battery pack is often used in the equipment now, and the lithium battery pack is usually composed of several single cell and protection circuit board. In this case, the whole lithium battery pack should meet the requirements of GB/T28164, and only the single cell in line with GB/T28164 is not enough, which should be noted.
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