In response to the urgent need to prevent, control, and eliminate the risks associated with public health emergencies, the State Food and Drug Administration (SFDA) has introduced a set of emergency approval procedures for medical devices. These procedures aim to ensure that essential medical equipment is registered and approved as quickly as possible during critical times. The new "Medical Device Emergency Approval Procedures" were recently issued and will take effect immediately upon publication.
The primary objective of these procedures is to streamline the regulatory process in the face of public health crises, ensuring that necessary medical devices can be made available swiftly. Based on existing regulations such as the State Council's Emergency Regulations on Public Health Emergencies and the Medical Device Supervision and Management Regulations, this framework provides a structured approach to emergency approvals.
Under the procedures, when a public health threat arises or an emergency occurs, the food and drug administration departments are required to implement emergency approvals following principles of unified command, early intervention, efficiency, and scientific evaluation. The SFDA will determine when to activate and terminate the procedure based on the situation and development of the emergency.
Once activated, all relevant authorities and technical institutions must work together to conduct registration tests, quality management system assessments, technical reviews, and administrative approvals according to their respective responsibilities and procedures. This ensures that all steps are carried out efficiently and effectively.
The procedures apply specifically to situations where no similar products are available in China, or even if similar products exist, they cannot meet the urgent needs of the emergency. Only medical devices confirmed by the SFDA are eligible for emergency approval.
Applicants seeking emergency approval must inform the relevant food and drug administration department about the product’s emergency conditions and development status. Authorities will monitor progress, conduct early interventions when needed, perform technical evaluations, and guide manufacturers through the approval process.
For devices under emergency review, applicants must submit summary information and instructions to the SFDA. A special expert group will assess and audit the device within three days, determining whether it qualifies for emergency approval and defining its classification.
Once approved, manufacturers must notify local food and drug administrations, which will then handle licensing and other necessary procedures. For second- and third-type devices, provincial authorities must issue or update manufacturing licenses within five days.
Testing institutions must complete registration tests within 24 hours of receiving samples and provide timely test reports. Quality management system assessments should be conducted within two days of receiving the application, with a report issued promptly.
Emergency applications will be marked as such, with dedicated personnel handling the materials. Technical reviews and administrative approvals must be completed within five days for first-type devices, while second-type devices require five days for technical review and three days for administrative approval. Third-type devices have a ten-day technical review period followed by three days for final approval.
These procedures are now in effect and represent a significant step toward improving the responsiveness of China's medical device regulatory system during public health emergencies.
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