State Drug Regulatory Director speaks | combating medical devices

Medical Network July 9th On July 6th, the State Food and Drug Administration met, the director deployed, and will focus on rectifying medical devices without license in 2018. This will be a new storm that will come after the medical device management rectification storm last year.

It is understood that the day was held 'National drug The supervision work symposium', which is considered to be one of the most important internal systems of the newly established State Food and Drug Administration after the institutional reform.

The three leaders of the Food and Drug Administration attended the meeting, including the party secretary, deputy director Li Li, director Jiao Hong, deputy director Xu Jinghe. This is the first time the leaders of the three bureaus have publicly unveiled.

It can be said that the meeting has a high specification and an important topic. The deployment is the focus of work in 2018. medical instruments enterprise It should be timely understood and given attention.

At the meeting, the director Jiao Hong made specific arrangements for the work in the second half of the year. Some of the contents involved medical equipment:

Jiao Hong said that it is necessary to strengthen supervision and crack down on illegal and illegal activities. Strengthen post-event supervision, focus on vaccines, blood products, injections, implanted medical devices and other high-risk products, and do on-site inspections of imported drug medical devices overseas R&D and production. Promote daily inspection 'double random' full coverage, inspection results are all public.

Implanted medical devices are basically three types, the risk requirements are extremely high, and the research and development costs of enterprises are also high. This year, it is necessary to increase supervision, which will undoubtedly bring new influence to enterprises. The 'double random' flight inspection is The 'normality' of medical devices in the past two years will not be weakened this year, but rather 'full coverage'.

Jiao Hong said that it is necessary to continue to carry out special rectification actions against unlicensed operation and operation of unlicensed medical devices. As early as June 2016, the then CFDA issued the "Remediation Announcement in the Field of Medical Device Distribution", which set off the circulation of medical device industry. The curtain of rectification.

By 2017, many provinces and cities across the country have not stopped, and the rectification continues. But more from the circulation to the use, that is, hospital And the rectification of the retail terminal market.

hospital, pharmacy Including various sales terminals for illegal sales and the use of medical devices, are listed as the focus of investigation. 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 supervision systems is not enough. We rarely see the news that medical institutions in violation of the regulations use medical equipment.

However, since the beginning of these two years, this kind of news has become more and more obvious, indicating that the drug supervisor is stepping up its duties, and the whole process supervises the research and development, production, circulation and use of medical devices.

At this meeting, Jiao Hong also proposed to establish a system of medical device adverse events, and promote the construction of electronic device submission information system for medical device registration applications.