It is understood that the medical device industry Cattle Ultrasound Scanner is brewing on a larger scale decree "replacement"recently,according to an official of Jiangsu Food and Drug Administration revealed that at present there are 30 or so levels of regulatory Decree which developed in the study is expected in the near two years of intensive introduction.
"To introduce legislation involving all aspects of the medical device lifecycle,and corporate marketing systems on the market so there will be a very big impact,the impact is expected to be reflected in the next two years."Officials said.
He revealed that the forthcoming legislation will be fully covered by medical device R & D,production,distribution,use of links,including research and development sectors,including the introduction of high-risk medical devices catalog,additional clinical review process,approved medical device clinical trials organization,particularly the trial of innovative medical devices assessment procedures;production processes,including GMP certification;circulation,including Internet sales,third-party logistics and quality management standards,etc.;use of links,including the development of yellow blacklist,launched a comprehensive electronic monitoring,adverse event monitoring and product recalls.
And drug regulation is different,the domestic regulation of medical devices sterilizers for sale is not in place is widespread,management compartmentalization rough,regulatory information,and are not networked,making it difficult for the quality,price and other strict supervision.Since last year,the state passed a provincial organization focused on high- value consumables and other ways to gradually start bidding on the price of medical supplies,the use of more stringent regulation.
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