Strengthening the supervision of medical devices in many places, equipment companies are facing big challenges

[Pharmaceutical Network Market Analysis] In recent years, China has focused on the actual development of the medical device industry and the public's demand for devices, and is constantly promoting the improvement of the medical device legal and regulatory system to promote the healthy and orderly development of the medical device industry
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Affected by this, in order to further promote the high-quality development of the medical device industry, various regions have successively developed a series of favorable plans and documents, and have also strengthened further supervision of the medical device industry
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For example, in order to strengthen the supervision of online sales enterprises of medical devices and improve the level of quality and safety management, the Market Supervision Bureau of Wuqing District, Tianjin recently launched the 2022 governance action of "online and offline regulations" for medical devices, both online and offline.
In terms of strengthening the investigation and rectification of potential risks of medical devices, to ensure the safety of the people in the jurisdiction when using devices
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So far, the bureau has found that the two companies are suspected of failing to file for the sale of contact lenses on Meituan online in accordance with regulations, and have launched an investigation
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In the next step, the Wuqing District Market Supervision Bureau will continue to adhere to the principles of online and offline linkage, information and product integration, strengthen the supervision and management of online sales of medical devices, and achieve work deployment, online monitoring, and offline inspections.
, The measures have been implemented, and the risk prevention and control and governance of violations of laws and regulations have been strengthened
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In addition, the Jiangxi Provincial Food and Drug Administration recently held the 2022 provincial medical device supervision work conference
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The meeting thoroughly implemented the spirit of the National Medical Device Supervision Work Conference, the National Drug Safety Special Rectification Work Conference, and the Provincial Market Supervision Work Conference, summarized the work in 2021, and deployed key tasks for 2022
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 　　Among them, the meeting made it clear that in 2022, the supervision of medical devices in Jiangxi Province will start with the in-depth development of special rectification actions for medical device safety, strictly prevent and control safety risks, and serve the overall situation of epidemic prevention and control
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Adhere to the strict investigation of cases, highlight the rectification of key enterprises, key varieties, and key regions, increase the research and judgment of risk signals, and investigate various potential risks
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Continue to strengthen the supervision of anti-epidemic equipment; strengthen unannounced inspections, strengthen online sales supervision, and strengthen coordination with public security, Internet information and other departments to form a joint crackdown on illegal acts
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 　　In addition, in order to further standardize the service order of the medical beauty market, ensure the safety of public use of makeup, medication and equipment, and effectively protect the legitimate rights and interests of consumers, on the occasion of the "March 8th" Women's Day, Haiyang Market Supervision Bureau is also in the city.
The internal organization carried out special inspections of medical devices in medical beauty institutions, further strengthened the quality and safety supervision of the use of medical devices in medical beauty institutions, and effectively guaranteed the safety of the people
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 　　From the above point of view, the compliance of medical device manufacturers has ushered in the era of strong supervision
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In response to national policy documents, the supervision of the medical device industry is becoming stricter and more frequent
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In the face of strict supervision, how should medical device companies respond? Industry insiders suggest that enterprises should strictly control the procurement of raw materials, select good suppliers, ensure product quality from the source, and prevent the risk of product quality problems; strictly implement and supervise product release and control procedures
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Check whether the product manual is consistent with the description of the scope of application, use accessories, and operation instructions of the recorded manual
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In a word, in the context of ushering in more aspects of supervision, relevant enterprises must first achieve compliance development
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Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
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