2024-03-01 08:39:23
[China Food and Drug Network]Strict prevention at the source, strict management of risks, strict control of risks, Guangdong deploys 2024 medical device production supervision and inspection work
China Food and Drug Network News Recently, the Guangdong Provincial Food and Drug Administration issued the Guangdong Province’s 2024 medical device production supervision and inspection plan, which is based on the principles of risk management and classified and hierarchical management, and adheres to strict source prevention, strict process management, and strict risk control. Strictly inspect key products and insist on not letting go until risks are eliminated; strictly inspect key links and insist on not letting go until hidden dangers are resolved; strictly inspect key enterprises and key areas and insist on not letting go if rectifications are not in place. Guided by the discovery of problems, we must pinpoint key control points and strengthen the surprise, penetration and substantive nature of inspections to create a deterrent effect for supervision and inspections.
It is reported that the inspection work deployed in Guangdong is mainly as follows: First, strictly inspect key products. Focus on supervising high-risk products such as sterile and implantable products, national innovative products, and products that attract high social attention such as medical protection, centralized procurement, and medical cosmetology. We will dig deep into illegal clues and strictly control hidden risks. The second is to strictly investigate key links. Strengthen supervision and inspection of entrusted production registrants and entrusted production enterprises, strengthen targeted inspections of key links and weak points of entrusted production, further consolidate the main responsibilities of enterprises, and standardize entrusted production behavior. The third is to strictly investigate key enterprises and key areas. There will be risk factors such as cross-border transfer of production, resumption of production after suspension, multiple administrative penalties, many problems found in the past, multiple batches, multiple varieties, and multi-year product sampling inspections that failed, frequent complaints and reports, and inadequate investigation and handling of adverse events. Relatively concentrated enterprises will be included in key regulatory targets; supervision and inspection efforts will be intensified to strengthen the implementation of responsibilities in industrial clusters, problem-prone areas, and areas with weak safety supervision. The fourth is to strengthen unannounced inspections. Based on problem orientation, unannounced inspections will be continued to strengthen the investigation and handling of handed-over problem clues and the tracking and implementation of corporate rectifications to ensure that hidden risks are effectively eliminated. The fifth is to improve the risk consultation mechanism. Adhere to a problem-oriented approach, focus on risks, products, enterprises and disposals, regularly organize and carry out medical device quality and safety risk consultations, and further enhance the timeliness, targeting and effectiveness of risk consultations; strengthen classified disposals and strengthen the implementation of responsibilities , strengthen thorough rectification and strengthen compliance construction. The sixth is to carry out follow-up inspection work. Organize follow-up inspections on manufacturing companies that fail to pass the random inspections supervised by the State Food and Drug Administration and the Guangdong Provincial Food and Drug Administration, production companies that are ordered to stop production for rectification and rectification within a time limit by the Provincial Food and Drug Administration’s unannounced inspections, and manufacturers that have newly obtained a medical device production license for more than half a year. . Seventh, severely crack down on violations of laws and regulations. Highlight the key points and focus on illegal activities such as unlicensed production and operation, production and operation of unlicensed products, continue to increase the intensity of case investigation, and severely punish illegal activities in serious cases in accordance with the law; strictly implement “punishment for individuals” and implement the confiscation of illegal income , restriction of employment, inclusion in the list of serious illegal and untrustworthy persons, joint punishment and other measures; disclose punishment information in accordance with the law, increase the exposure of cases, effectively play the role of warning and education, and form a strong deterrent.
The Guangdong Provincial Food and Drug Administration will focus on the 2024 medical device production supervision and inspection plan, conscientiously implement the “four most stringent” requirements, conscientiously implement the spirit of the 2024 National Medical Device Supervision and Administration Work Conference, strictly implement the regulatory responsibilities of the local regulatory authorities, and consolidate the enterprises The main responsibility is to strengthen the whole life cycle quality supervision. (Chen Hairong)
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