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In 2018, we will focus on rectifying the unlicensed operation of medical devices
On July 6, the State Food and Drug Administration held a meeting and the director deployed that in 2018, it will focus on rectifying the unlicensed operation of medical devices. This will be a new storm that will come after the storm of medical device operation and rectification last year.
It is understood that the "National Drug Regulatory Work Symposium" was held that day, which can be regarded as one of the most important internal system meetings held by the newly established State Drug Administration for the first time after the institutional reform.
All three leaders of the China Food and Drug Administration attended, including Secretary of the Party Leadership Group and Deputy Director Li Li, Director Jiao Hong, and Deputy Director Xu Jinghe. This is also the first public appearance of the three bureau leaders.
It can be said that this meeting has high specifications and important topics. The deployment is the focus of work in 2018. Medical device companies should understand and pay attention to it in a timely manner.
Director Jiao Hong made specific arrangements for the work in the second half of the year at the meeting, some of which involved medical devices:
Jiao Hong said that it is necessary to strengthen supervision and severely crack down on violations of laws and regulations. Strengthen supervision during and after the event, focus on high-risk products such as vaccines, blood products, injections, implantable medical devices, and conduct on-site inspections for overseas R&D and production of imported pharmaceutical and medical devices, promote full coverage of daily inspections, and make inspection results public .
There are basically three types of implantable medical devices, with extremely high risk requirements, and high R&D costs for enterprises. Increased supervision this year will undoubtedly bring new impacts on enterprises. The "double random" unmanned inspection, etc., have been the "normal" for medical devices in the past two years, and this year will not be weakened, but "full coverage."
Jiao Hong said that it is necessary to continue to carry out special rectification actions against unlicensed operation and the operation and use of unlicensed medical devices. As early as June 2016, the then CFDA issued the "Announcement on the Remediation of the Medical Device Circulation Field", which set off the curtain on the remediation of the medical device industry.
By 2017, many provinces and cities across the country did not stop at all, and the rectification continued. But more from the circulation link to the use link, that is, the renovation of hospitals and retail terminal markets.
Hospitals and pharmacies, including various point-of-sales illegal sales and use of medical devices, are all listed as key investigations and punishments. In 2018, this action will continue.
In the past, it can be said that the supervision of the use of medical equipment, medical consumables and reagents by medical institutions by the drug supervision system may not be strong enough, and we have rarely seen news about the illegal use of medical devices by medical institutions in the drug supervision and administration department.
But since the beginning of the past two years, such news has obviously increased, indicating that the drug administration is stepping up its responsibilities to supervise the research and development, production, circulation and use of medical devices throughout the process.
At this meeting, Jiao Hong also proposed to establish a medical device adverse event system and promote the construction of an information system for the electronic submission of medical device registration applications.
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2019-11-21
2019-11-21
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