The supervision and administration regulations rules of medical apparatus and instruments has the first big change in 14 years ,the new regulations will be formally implementedin June 1st this year. The new regulations, not only in the "pre IPO"supervision, focusing on regulation of higher risk products, medical devices by classified management according to the risk degree; and in the "market" regulation, additional medical device adverse event monitoring, evaluation and recall system, regulatory tentacles throughout the whole industry chain. And the current regulations of the 16 administrative approval, the revised draft does not add newlicense, and combined with the previous administrative permission to clear out, total 7 items of administrative licensing. In addition tocancel the second type of medical device clinical trial approval,cancel the medical institutions development of medical deviceapproval, cancel the third types of medical equipment mandatory safety certification, reduced third class medical device clinical trialapproval scope.
According to the insiders, the implementation of the new regulations,to "establish the most stringent covering the whole processsupervision system", while the definition of third kinds of instrumentsmore broadly, the government for some products are more than before the power of life and death.
Source: Southern Metropolis Daily
