In response to the urgent need to prevent, control, and mitigate the risks associated with public health emergencies, the State Food and Drug Administration (SFDA) has introduced the "Emergency Approval Procedures for Medical Devices." This initiative was recently issued, and it will come into effect immediately upon its promulgation. The procedures consist of 14 key guidelines aimed at expediting the registration and approval of essential medical equipment during critical times.
The primary objective of these emergency procedures is to ensure that medical devices required for public health crises are reviewed, tested, and approved as quickly as possible. These procedures are based on existing regulations such as the State Council’s Emergency Regulations on Public Health Emergencies, along with the Medical Device Supervision and Management Regulations and the Measures for the Administration of Medical Device Registration.
Under Article 2, when a public health emergency is imminent or has already occurred, food and drug regulatory authorities must follow the principles of unified command, early intervention, rapid response, and scientific evaluation to expedite the approval of necessary medical devices. Article 3 outlines that the SFDA will determine the start and end of the emergency procedure based on the situation's development.
Once the procedure is activated, all levels of food and drug regulatory departments and technical institutions will perform registration tests, quality system assessments, technical reviews, and administrative approvals according to their roles and established procedures.
Article 4 specifies that the procedure applies to situations where no similar products are available in China, or even if similar products exist, they cannot meet the urgent demand. Only medical devices confirmed by the SFDA can qualify for emergency approval.
Article 5 requires applicants to inform the relevant authorities about the product's emergency status and development progress in advance. Regulatory agencies will monitor the development of such devices, conduct early interventions, and provide guidance for the declaration process.
Article 6 mandates that applicants submit summary information and instructions to the SFDA. A special expert group will assess the device within three days and confirm whether it qualifies for emergency approval.
For devices approved under emergency conditions, manufacturers must notify local authorities and obtain necessary licenses. Provincial regulators will process applications promptly, ensuring timely issuance or modification of manufacturing licenses.
Additionally, testing institutions are required to complete registration tests within 24 hours and issue test reports promptly. Quality management system assessments must be conducted within two days of receiving an application, and registration materials will be handled urgently once accepted.
Technical reviews and administrative approvals will be completed within five days for second- and third-type devices, with additional time allocated for more complex cases. These streamlined processes aim to accelerate the availability of critical medical equipment during public health crises.
Overall, the implementation of these emergency procedures ensures a faster, more efficient, and coordinated approach to medical device regulation during times of national urgency.
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