New rule to target medical tool safety
<p><span word="Download">Download</span></p><p><span word="A">A</span> <span word="new">new</span> <span word="regulation">regulation</span> <span word="governing">governing</span> <span word="the">the</span> <span word="supervision">supervision</span> <span word="and">and</span> <span word="management">management</span> <span word="of">of</span> <span word="medical">medical</span> <span word="equipment">equipment</span> <span word="has">has</span> <span word="been">been</span> <span word="unveiled">unveiled</span> <span word="to">to</span> <span word="ensure">ensure</span> <span word="safety">safety</span> <span word="and">and</span> <span word="effectiveness">effectiveness</span> <span word="and">and</span> <span word="encourage">encourage</span> <span word="innovation">innovation</span>.</p><p><span word="The">The</span> <span word="rule">rule</span>, <span word="which">which</span> <span word="will">will</span> <span word="take">take</span> <span word="effect">effect</span> <span word="on">on</span> <span word="June">June</span> 1, <span word="is">is</span> <span word="an">an</span> <span word="amendment">amendment</span> <span word="of">of</span> <span word="a">a</span> <span word="regulation">regulation</span> <span word="first">first</span> <span word="enacted">enacted</span> <span word="in">in</span> 2000. <span word="An">An</span> <span word="executive">executive</span> <span word="meeting">meeting</span> <span word="of">of</span> <span word="the">the</span> <span word="State">State</span> <span word="Council">Council</span>, <span word="led">led</span> <span word="by">by</span> <span word="Premier">Premier</span> <span word="Li">Li</span> <span word="Keqiang">Keqiang</span>, <span word="endorsed">endorsed</span> <span word="the">the</span> <span word="latest">latest</span> <span word="version">version</span> <span word="in">in</span> <span word="February">February</span>.</p><p>"<span word="Safe">Safe</span> <span word="and">and</span> <span word="effective">effective</span> <span word="medical">medical</span> <span word="equipment">equipment</span> <span word="has">has</span> <span word="a">a</span> <span word="direct">direct</span> <span word="bearing">bearing</span> <span word="on">on</span> <span word="public">public</span> <span word="health">health</span> <span word="and">and</span> <span word="social">social</span> <span word="stability">stability</span>," <span word="said">said</span> <span word="Jiao">Jiao</span> <span word="Hong">Hong</span>, <span word="food">food</span> <span word="and">and</span> <span word="drug">drug</span> <span word="safety">safety</span> <span word="chief">chief</span> <span word="of">of</span> <span word="the">the</span> <span word="China">China</span> <span word="Food">Food</span> <span word="and">and</span> <span word="Drug">Drug</span> <span word="Administration">Administration</span>. "<span word="The">The</span> <span word="new">new</span> <span word="rule">rule</span> <span word="will">will</span> <span word="enhance">enhance</span> <span word="routine">routine</span> <span word="oversight">oversight</span> <span word="of">of</span> <span word="equipment">equipment</span> <span word="in">in</span> <span word="the">the</span> <span word="market">market</span>."</p><p><span word="The">The</span> <span word="old">old</span> <span word="version">version</span> <span word="of">of</span> <span word="the">the</span> <span word="regulation">regulation</span> <span word="could">could</span> "<span word="no">no</span> <span word="longer">longer</span> <span word="adapt">adapt</span> <span word="to">to</span> <span word="new">new</span> <span word="situations">situations</span>," <span word="she">she</span> <span word="said">said</span>, <span word="citing">citing</span> <span word="unsatisfactory">unsatisfactory</span> <span word="classification">classification</span> <span word="of">of</span> <span word="equipment">equipment</span>, <span word="insufficient">insufficient</span> <span word="oversight">oversight</span> <span word="and">and</span> <span word="unspecified">unspecified</span> <span word="legal">legal</span> <span word="accountability">accountability</span>, <span word="among">among</span> <span word="other">other</span> <span word="problems">problems</span>.</p><p><span word="When">When</span> <span word="the">the</span> <span word="new">new</span> <span word="rules">rules</span> <span word="take">take</span> <span word="effect">effect</span>, <span word="regulation">regulation</span> <span word="of">of</span> <span word="medical">medical</span> <span word="equipment">equipment</span> <span word="will">will</span> <span word="be">be</span> <span word="divided">divided</span> <span word="into">into</span> <span word="three">three</span> <span word="categories">categories</span> <span word="according">according</span> <span word="to">to</span> <span word="the">the</span> <span word="health">health</span> <span word="risks">risks</span> <span word="they">they</span> <span word="might">might</span> <span word="pose">pose</span> <span word="for">for</span> <span word="customers">customers</span>.</p><p>"<span word="Those">Those</span> <span word="deemed">deemed</span> <span word="high">high</span>-<span word="risk">risk</span> <span word="are">are</span> <span word="expected">expected</span> <span word="to">to</span> <span word="be">be</span> <span word="regulated">regulated</span> <span word="more">more</span> <span word="strictly">strictly</span>," <span word="said">said</span> <span word="Tong">Tong</span> <span word="Min">Min</span>, <span word="head">head</span> <span word="of">of</span> <span word="the">the</span> <span word="medical">medical</span> <span word="equipment">equipment</span> <span word="supervision">supervision</span> <span word="and">and</span> <span word="management">management</span> <span word="department">department</span> <span word="of">of</span> <span word="the">the</span> <span word="administration">administration</span>.</p><p><span word="To">To</span> <span word="better">better</span> <span word="facilitate">facilitate</span> <span word="the">the</span> <span word="regulation">regulation</span>, <span word="the">the</span> <span word="top">top</span> <span word="drug">drug</span> <span word="authority">authority</span> <span word="will">will</span> <span word="set">set</span> <span word="up">up</span> <span word="a">a</span> <span word="monitoring">monitoring</span> <span word="system">system</span> <span word="to">to</span> <span word="track">track</span> <span word="adverse">adverse</span> <span word="events">events</span> <span word="caused">caused</span> <span word="by">by</span> <span word="medical">medical</span> <span word="equipment">equipment</span>, <span word="along">along</span> <span word="with">with</span> <span word="a">a</span> <span word="reappraisal">reappraisal</span> <span word="mechanism">mechanism</span> <span word="and">and</span> <span word="a">a</span> <span word="recall">recall</span> <span word="system">system</span> <span word="for">for</span> <span word="defective">defective</span> <span word="equipment">equipment</span>.</p>
页:
[1]