Hebei: Medical device safety emergencies must be reported within 2 hours

Recently, the Food and Drug Administration of Hebei Province issued the “Emergency Plan for the Emergency of Drugs and Medical Devices in Hebei Province (Trial)”. The promulgation of the emergency plan will guide and standardize the emergency response of drug and medical device safety emergencies in our province, effectively prevent and timely control all kinds of drug and medical device safety emergencies, and minimize the emergency to the public. Health and life safety hazards.

According to the hazard level and scope of the incident, the safety incidents of drugs and medical devices in our province are classified into Grade I (especially significant), Grade II (significant), Grade III (larger) and Grade IV (higher to lowest). general).

The emergency plan requires that the food and drug supervision and administration departments at all levels should establish a monitoring system for the safety emergencies of drugs and medical devices, and strengthen the daily supervision of key varieties and key links, especially the quality and safety of high-risk varieties. Collect drug and medical device safety information and emergency information through adverse drug reaction or medical device adverse event monitoring system, drug abuse monitoring system, complaint reporting system and inspection and detection mechanism to monitor potential drug and medical device safety incident information.

Pharmaceutical production and management enterprises shall report to the local food and drug supervision and administration department, the adverse drug reaction or medical device adverse event monitoring agency immediately after discovering or knowing the drug safety emergencies, and the medical institution shall discover or know the safety of drugs and medical devices. After an emergency occurs, it shall immediately report to the local health and family planning administrative department and report to the local food and drug supervision and administration department. The reporting time must not exceed 2 hours at the latest.

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After receiving the report, the food and drug supervision and administration department of the incident shall report to the local government and the superior food and drug supervision and management department within 2 hours, and immediately go to the scene to investigate and verify the incident.

The food and drug supervision and administration departments at all levels shall analyze the risk factors related to the safety emergencies of drugs and medical devices in the administrative region according to the monitoring information, and the risk factors, risk levels, scope of influence, urgency and possible existence that may endanger public health. The hazard is submitted for analysis and evaluation, and reports to the food and drug supervision and administration department at the next level.

Corresponding to the grading of drug and medical device emergencies, the emergency response of drugs and medical devices emerged from low to high, which are divided into four levels: IV, III, II and I.

When it is approved as a general drug and medical device emergency, the county (urban) food and drug supervision and administration department of the accident occurred to initiate a Class IV response, and report to the district food and drug supervision and administration department and the county (urban) government. In the case, the department related to the incident, such as the health and family planning administration, is notified.

When it is approved as a major drug and medical device emergency, the district-level food and drug administration of the accident will initiate a Level III response, and notify the Provincial Food and Drug Administration, the district/city government, and the health and family planning administration. The department associated with the incident.

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