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95 item of medical instrument standard is integrated ??
On April 6, the state food and drug supervision and administration bureau (CFDA) web site, to implement the standardization issued by the state council on deepening the reform of the circular (guo fa [2015] no. 13) and the state council general office on the notice issued by the mandatory standard streamlined work plan (countries do hair [2016] no. 3) requirements, recently, the bureau deployed to carry out the relevant mandatory standards streamlined work.??
Among them, the streamlined include medical devices mandatory national standards, 95 plan and revising 32; Mandatory industry standards, the 385 plan and revising 79 items. Integration of streamline involves the mandatory national standards 10 cosmetics, 13 and revising plans. According to the report, this work by the general administration of standard of science and technology department in conjunction with the drug registration division, device registration department, drug supervision, equipment and supervision, such as the departments jointly organized, medical equipment management center, cosmetics standard committee of experts, and a number of units in each medical equipment standardization technical committee.?
The work involves different kinds of standards, streamlined task time is tight, high requirements, big workload. Through a batch of "abolished, into a batch, integration of a batch and revised a number of" way of solve overlapping conflicts and other major problems of the compulsory standards. ??
Who set standards for medical devices industry? ??
The CFDA's food and drug verification research institute under the China equipped with medical equipment standard management institute, institute is equipped with active passive medical equipment medical instrument standard room, standard room, in vitro diagnostic standard room and standard system of laboratory, etc.?
Institute's main responsibilities include taking the CFDA medical equipment standard management center of daily work, take medical equipment standards and formulate relevant transactional work, organize and coordinate relevant professional standardization technical committee of medical equipment to carry out the system of medical instrument standard revision work, etc.??
It is understood that standards for medical devices industry usually CFDA directly under the main drafting unit, scattered around medical equipment quality supervision and inspection center, as well as the various provinces and cities "medical instrument examination center" (testing, testing by the court), also includes the enterprise organization, etc.??
Such as in November 2015 CFDA publish a batch of medical device industry standards, shandong xinhua medical instrument co., LTD. Is mainly drafted "sterilization steam quality test method" "medical electrical heating steam generator type" two industry standard, guangzhou daming united rubber products co., LTD mainly drafted "rubber natural rubber latex condom condom use in the quality management guide to GB 7544" industry standards. ??
New gb, a new market opportunities??
chairman of the China council for the promotion of medical apparatus and instruments WeiShaoFeng think, many industry standards is closely related to the enterprise product technology, similar to patents, the industry standard also tend to be as an important means of market competition, enterprises of industry standard makers by setting the industry standard, set the threshold for competitors to enter the market, improve the market access conditions, to get a more favorable competitive environment for himself. ?
He thinks, the enterprise competition is divided into three levels, including product competition, patent/standard competition, brand competition, at present most of the medical equipment enterprise is still in the stage of product competition, relatively junior. This involves the adjustment of 95 national standards for medical devices industry, streamline, some enterprises will lose "access protection", the other part of the enterprise could gain new opportunities. For agents, can focus on the adjusted products that meet the "new gb", even "new gb" drafting unit of the corresponding products, to form a more powerful their own competitive advantage.
