The Guiding Principles for Medical Devices' Conditional Approval for Marketing is issued by the State Food and Drug Administration
Recently, the State Drug Administration issued the "Guiding Principles for Conditional Approval of Medical Devices" (hereinafter referred to as the "Principle"). The Principles define the scope, principles, basic requirements, and communication mechanisms for the medical device's conditional approval for listing, and regulate the preclinical research, clinical trials, conditionalities, and post-marketing monitoring of such medical devices.
The Principles point out that for medical devices that have been approved for marketing with conditions, the data collected before the listing should be able to prove that the medical device has shown efficacy and can reasonably predict or judge its clinical value. The balance between the data collected before the listing and the comprehensive assessment of the product's risk and benefit.
The "Principle" requires that from the demonstration of conditional approval for listing, the establishment of the attached conditions, and the collection of post-marketing data, the conditional approval for listing of medical devices for clinical trials has flexibility, but must not reduce product safety and effectiveness Sex comprehensive evaluation requirements. During the application process for the application for product registration and after the listing is conditionally approved, the applicant and registrant shall continue to conduct clinical trials and complete other research work and requirements in accordance with the established clinical trial scheme. Applicants and registrants can also submit communication applications to technical review institutions for major technical issues, major safety issues, clinical trial protocols, and the completion of conditions attached to registration certificates.
The "Principle" emphasizes that medical device registrants should complete the requirements for listing approval conditions listed in the remarks column of the product registration certificate within the prescribed time limit, and prompt product risks in product labels and instructions.
After the medical devices are approved for sale with conditions, the Principles have also made clear specifications for post-market monitoring of such products, requiring the monitoring of adverse events to be strengthened. When the relevant evidence shows that the risk of the product outweighs the benefits, or the re-evaluation cannot prove the safety and effectiveness of the product, the registrant should promptly apply for cancellation of the registration certificate.
As a medical device automation assembly equipment manufacturer, Dongguan Nanfang Lijin Machinery Co., Ltd. has been paying attention to the release of national policies, industry trends and other 澳门现金娱乐网投. If such reproduced 澳门现金娱乐网投 violates your rights, please 澳门现金娱乐网投 in time. We Will be removed from the shelf in time.
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