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Drug Administration medical device companies held in Beijing on behalf of the forum
It is reported that recently , the State Food and Drug Administration regulation of medical devices company in Beijing organized a Medical Device manufacturing enterprises forum. At the meeting, the Secretary for extensive medical device regulatory participants listened to medical device companies around the views of the representatives , the two sides had in-depth exchanges and discussions .
At the forum, medical device regulatory Food and Drug Administration Division of the leaders on the agency adjusted Yixie regulatory ideas were introduced. Waist Administration 2020, in preparation Yixie supervision in three steps , first in 2013 and 2015, the risk of wind control as a priority, and the people on the high-risk Yixie reflect outstanding issues and to focus on solutions ; 2016 2018, will be the construction of information technology as a key to achieve national Yixie interconnection and regulatory information flow ; 2019 to 2020, to establish a sound regulatory system , improve the quality of supervision team , establish a sound regulatory system and establish Yixie international standards and regulatory system .
At the forum, participants Yixie business representatives also put forward their views and suggestions. First, the Internet sales of fake and shoddy medical products more, and many do not have the qualifications Yixie sales outlets , there is illegal behavior , business representatives suggested Yixie Administration to strengthen the supervision of network marketing efforts . Second, in Yixie tender , local companies are required to provide medical evidence is not illegal , and various qualification certificates , business representatives hope Drug Administration to take advantage of information technology platform , regularly updated business intelligence documents and did not violate laws proof , so do not re- submit a cumbersome paper dielectric material . Third , business representatives also called for the introduction of new amendments as soon as possible Yixie regulatory ordinance development of the industry to play a regulatory role in ensuring the healthy development of the industry Yixie . In addition , the delegates also proposed development of the industry Yixie some common problems, such as , for violations of law Yixie enterprises to increase penalties , to establish a market launch of the system , to strengthen the training of employees in Yixie ; improve operating Yixie enterprise access conditions , strengthen the monitoring of adverse events Yixie network construction and so on.