The announce that controls sampling observation outcome about releasing national medical apparatus and instruments (the 3rd)
(2019 the 20th)
Control government to enhance quality of medical apparatus and instruments, use safety of product of safeguard medical apparatus and instruments is effective, supervisory management board of national medicines and chemical reagents organizes pair of γ - cereal ammonia acyl base move is enzymatic determine reagent (box) , medical X ray defends appliance (defend the garment, skirt, scarf) , human body blood and type of haemal composition bag are plastic container (hematic bag) wait for 7 breed in all, among them 25 batches (stage) the product does not accord with a standard to set. Particular case announcement is as follows:
Be notted agree with to combine the product of medical apparatus and instruments that the standard provides by sampling observation project, 6 variety that involve 17 companies 19 batches (stage) . Specific for:
(one) γ - cereal ammonia acyl base move is enzymatic determine reagent (box) 2 enterprises 2 batch product. The 1 batch γ that limited company of technology of content of Zhejiang blessing Kang Sheng produces - move of cereal ammonia acyl is enzymatic determine reagent box (monitor a law continuously) , Zhejiang peaceful the 1 batch γ that content technology limited company produces Sitesheng - move of cereal ammonia acyl is enzymatic (, linear does not accord with a standard to set.
(2) osculatory sex achieves face dressing 2 enterprises 2 batch product. The acerbity salt of 1 batch alga that Henan collects Inc. of rich medical treatment to produce is medical the 1 batch alga that limited company of medical apparatus and instruments produces benefit of family of city of dressing, Guangzhou is acerbity saline dressing, acid-base value experiment does not accord with a standard to set.
(3) without achieve measure tonometer automatically (electronic tonometer) 2 enterprises 2 products. Wuhan an electron tonometer that Inc. of science and technology of medicine of all places hall produces, belt of the biggest sleeve is pressed, but accuracy of repeatability, pressure sensor does not accord with a standard to set; A data that limited company of science and technology of electron of the dispatch in Jiangsu produces is transmitted model electronic tonometer, the color of indicator light does not accord with a standard to set.
(4) dilator of vagina of one-time use asepsis 4 enterprises 5 batch product. Health clean of city of the 2 batch that limited company of development of Kang Minwei material of city of new rural area produces, Nanchang is medical and wholesome the 1 batch that things limited company produces is one-time dilator of use asepsis vagina, allowance of incomplete of annulus oxygen ethane does not accord with a standard to set; Changzhou city annulus health the 1 batch that limited company of medical apparatus and instruments produces is one-time dilator of use asepsis vagina, fight be out of shape ability does not accord with a standard to set; Changzhou city achieves the 1 batch that limited company of medical apparatus and instruments produces beautiful dilator of vagina of one-time use asepsis, structural intensity does not accord with a standard to set.
(5) one-time use medical guaze mask 5 enterprises 6 batch product. Jiangsu province always coulds there be the 2 batch that limited company of medical apparatus and instruments produces are one-time use medical guaze mask, guaze mask belt, bacterium filters efficiency (BFE) do not accord with a standard to set; The 1 batch of production of limited company of science and technology of biology of Zhejiang Yi Lu Bo is one-time use medical the 1 batch that limited company produces Hua Kangwei material of city of guaze mask, new rural area is one-time use medical 1 what limited company of medical apparatus and instruments produces grand of division of province of guaze mask, Henan, the bacterium filters efficiency (BFE) do not accord with a standard to set; The 1 batch of city of new rural area of production of production limited company of easy medical apparatus and instruments is medical guaze mask, microbial index does not accord with a standard to set.
(6) medical X ray defends appliance (defend the garment, skirt, scarf) 2 enterprises 2 batch product. The 1 batch that limited company of Beijing Ba Ruide medical apparatus and instruments produces is medical ray safety glove, material does not accord with a standard to set; The 1 batch that Suzhou Kang Shidun defends limited company of science and technology is produced is medical cutting means enclosure of ray sexual gland, the design does not accord with a standard to set.
Above sampling observation does not accord with standard compasses a system of fixed quotas for grain production to taste particular case, see accessory 1.
2, the product of medical apparatus and instruments that is notted agree with to add up to a standard to set for the project such as label label, manual by sampling observation project, 2 variety that involve 7 companies 7 batches (stage) , specific for:
(one) without achieve measure tonometer automatically (electronic tonometer) 4 enterprises 4 products. Ohmic dragon (Dalian) the electron of an artifice type that deer of an electron tonometer of limited company production, Jiangsu gets Inc. of medical treatment electron to produce electron of tonometer, medical treatment adding up to peaceful (Suzhou) the series of a HL8 that limited company produces limited company of science and technology of electron of the dispatch in tonometer of electron of type of the upper arm, Jiangsu, the label asks not to accord with a standard to set.
(2) medical X ray defends appliance (defend the garment, skirt, scarf) 3 enterprises 3 batch product. The 1 batch of production of limited company of Shandong Shuang Ying medical apparatus and instruments is medical X ray defends series goods (plumbic vest) , the 1 batch of dragon mouth city of production of limited company of contemporary medical apparatus and instruments is medical the ray of 1 batch X that diagnostic X ray defends state of bright of apron, Yantai defends limited company of science and technology is produced defends take, sexual gland, mark does not accord with a standard to set.
Above sampling observation does not accord with standard compasses a system of fixed quotas for grain production to taste particular case, see accessory 2.
3, 5 breed that sampling observation project accords with the product of medical apparatus and instruments that the standard provides to involve 85 companies entirely 126 batches (stage) , see accessory 3.
4, do not accord with a standard to provide a product to what discover in afore-mentioned sampling observation, supervisory management board of national medicines and chemical reagents already asked enterprise seat is provincial supervisory management department of medicines and chemical reagents supervises and urge relevant enterprise according to " medical apparatus and instruments monitors regulation " " recall of medical apparatus and instruments runs way " wait for code the product that regulations asks not to accord with a standard to set to sampling observation undertakes the risk is evaluated, determine recall level according to the serious degree of blemish of medical apparatus and instruments, active recall product publishs recall information. In the meantime, the enterprise should find out a product as soon as possible unqualified reason, make rectify and reform measure and rectify and reform on schedule reach the designated position, about deal with circumstance on May 20, 2019 forward the society is announced, seasonable will relevant circumstance reports to seat provincial medicines and chemical reagents supervises management department.
5, supervisory management department of provincial medicines and chemical reagents answers enterprise seat relevant enterprise undertakes investigating handling, undertake to the enterprise product recall, unqualified reason is investigated, fulfil rectify and reform the circumstance such as measure and public exposure information to undertake supervisory; The product causes harm to perhaps evidence proves the likelihood endangers human body health to human body, should accept suspension lawfully production, manage, use urgent control measure; Need suspends an import, answer to sign up for national medicines and chemical reagents in time to supervise management board to make administration handle a decision. The enterprise did not fulfil afore-mentioned requirements by the requirement, supervisory management department of provincial medicines and chemical reagents should investigate seat gravely lawfully. Concerned information should be made public in time to the society.
6, above fulfils a circumstance each, relevant and provincial medicines and chemical reagents supervises management department to control management board at medicines and chemical reagents of nation of the report before May 30, 2019.
Hereby announce.
Bureau of national medicine inspect on April 28, 2019
Accessory
Accessory 1: Sampling observation of national medical apparatus and instruments does not accord with a standard to provide product list
Accessory 2: Sampling observation of national medical apparatus and instruments (the project such as label label manual) do not accord with a standard to provide product list
Accessory 3: Sampling observation of national medical apparatus and instruments accords with a standard to provide product list
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