Qinghai News Network·Damei Qinghai Client News On March 15, the reporter learned from the Qinghai Provincial Drug Administration that in order to further standardize the registration and management of medical devices in the province, combined with the province’s drug In the special rectification action for safety, the Provincial Drug Administration organized the clean-up and standardization of Class II medical devices.
It is reported that this clean-up and normative work is divided into four stages: self-inspection, rectification, supervision and summary. Focus on checking whether non-medical devices are registered as medical devices, whether they are “high class and low batch”, and whether they meet the requirements of relevant classification and definition documents such as the “Medical Device Classification Rules”. Whether the medical device registration application materials meet the statutory requirements, whether the form is complete, and whether the registration review is carried out in accordance with the technical review requirements. Whether the medical device registration work has established an approval process and is effectively implemented in accordance with the “Regulations for the Approval and Approval of Domestic Class II Medical Device Registration” and other documents, and whether there are local regulations that are inconsistent with laws and regulations.
During this clean-up and standardization work, the Provincial Drug Administration will review the product registration materials one by one, and correct the device registration management work with full coverage and no dead ends. problems in . In view of the problems found, in-depth research and timely rectification are carried out to ensure that the product registration management meets the relevant regulations. At the same time, local regulations that are inconsistent with the requirements of medical device supervision regulations are promptly abolished to ensure fair and just product registration.
[Source: Qinghai News Network]
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