The Head Of The State Drug Administration Has Called For A Crackdown On Such Practices
Medical network on July 9 - July 6, the state food and drug administration for the meeting, the director of deployment, in 2018 will focus on renovation unlicensed operation of medical equipment, this will be so medical equipment management regulation last year after the storm, and the arrival of the new storm.
Held on the same day, according to understand, is "the national drug regulatory work symposium", it is after the institutional reform, and the newly established internal system of the state food and drug administration for the first time held a one of the most important meeting.
All three heads of the food and drug administration attended the meeting, including the secretary of the party group and deputy director li li, director jiao hong and deputy director xu jinghe.It was also the first time the three bureau leaders made a public appearance.
It can be said that this meeting is of high specifications and important issues. What is deployed in 2018 is the focus of work. Medical device enterprises should timely understand and attach importance to it.
Bureau chief jiao hong made specific arrangements for the work in the second half of the year at the meeting, part of which involved medical devices:
'we need to strengthen supervision and crack down on illegal and illegal activities,' Ms. Jiao said.Strengthen matter afterwards regulation, focusing on vaccines, blood products, injection, risky products such as medical devices implanted class, completes the imported drugs overseas research and development production site inspection, medical instrument drive daily check the complete coverage of "double random", all public examination result.
Implantable medical devices are basically classified into three categories, with high risk requirements and high research and development costs. This year, more regulation will undoubtedly bring new impacts to enterprises.The "double-random" flying test is the "normal" of medical devices in the past two years. It will not be weakened this year, but "full coverage".
Jiao hong said that the crackdown on the operation and use of unlicensed medical devices should continue.As early as June 2016, at that time, CFDA issued the "regulation announcement on medical device circulation", which raised the curtain of medical device industry circulation regulation.
By 2017, many provinces and cities across the country have not stopped, and the crackdown is continuing.But more from circulation to use, that is, hospitals and retail terminal market regulation.
Hospitals and pharmacies, including illegal sales of various sales terminals and the use of medical equipment, are listed as the behaviors of key investigation and punishment.In 2018, the campaign will continue.
In the past, to say the drug safety system for medical institutions use regulation behavior of medical equipment and medical consumables and reagents may strength is not enough, we rarely see drug safety investigate violations of medical institutions use of medical equipment.
But since the beginning of these two years, there has been a significant increase in such news, indicating that the fda is stepping up its responsibilities to monitor the development, production, circulation and use of medical devices throughout the process.
At the meeting, jiao also proposed to establish a medical device adverse event system and promote the construction of electronic submission information system for medical device registration applications.