Nhanganyaya ku
Iyo Chikafu neDrug manejimendi ibazi reUS department rehutano, dzidzo nekugara zvakanaka.Kutaura chokwadi, iyo FDA yakafanana nebazi rezvehutano (rine basa rekubvumidza chikafu chehutano) uye yenyika kutonga kwemishonga (inotarisira kubvumirwa kwemishonga).Iyo inoona nezvemishonga yenyika, chikafu, biological products, cosmetics, veterinary medicine, Yliao equipment uye diagnostic products uye humwe hutungamiri uye kushanda kuchengetedza, kusimudzira nekuvandudza hutano hwenyika, kuve nechokwadi chokuti kutengeswa kwemusika weAmerica. chikafu, mushonga, cosmetics uye Yliao zviridzwa zvekuchengetedza uye kushanda kwemuviri wemunhu.Iyo FDA chiremera chezvinodhaka, agency, veterinary mushonga Bureau, hutano Bureau, hofisi yezvigadzirwa zvebiological, Yliao zviridzwa uye diagnostic zvinhu Bureau uye yenyika toxicology nzvimbo dzekutsvagisa, redunhu basa manejimendi masangano, ayo matanhatu innings (mamwe mabhuku anotiwo matanhatu centre), a muzinda uye nharaunda manejimendi masangano.
Kuwanda kweFDA
Zvigadzirwa zvekurapa
- X-ray diagnostic Yliao chigadzirwa (chakawanda kushandiswa, fluorescent X - ray, CT, nezvimwewo)Kuvhiya uye mamwe laser midziyo uye midziyo ine laser unit-- laser zvigadzirwa zvezvinangwa zvakakosha (kusanganisira kuratidza, kutarisa uye kushandiswa kwekurapa)- uv midziyo yekurapa (uv rambi uye zvigadzirwa zveYliao)Mimwe midziyo yekurapa ye Ultrasound yezvisiri zvemuviri kurapa uye kuongororwa-- microwave diathermy therapy uye microwave blood heater-- ultrasonic physical therapy equipment
ETL certification ine chekuita nezvayo
ETL certification inodiwa kuti iendeswe kunze kuUnited States neCanada.Mucherechedzo weETL unoratidza kuti chigadzirwa chapfuura bvunzo yemvumo yeNRTL muUnited States uye SCC muCanada.Intertek ndeimwe yemasangano mashoma ezvitupa anozivikanwa neOSHA neSCC. Shenzhen anbo ine hukama hwepedyo neintertek, iyo inogona kubatsira zvigadzirwa zvako kuwana ETL certification uye kupa masevhisi akazara.Kuzivikanwa kwechiratidzo cheETL kwakafanana neUL kana CSA chiratidzo uye inosangana neakakodzera miitiro yekuchengetedza.Kuve neETL column zita mureza wechigadzirwa zvinoreva kuti yakasangana nezvinodiwa zvishoma zvezviyero zvekuchengetedzwa kwechigadzirwa. Pamusoro pezvo, chiratidzo cheETL chinoratidzawo kuti saiti yekugadzira yemugadziri inosangana nehumwe huwandu hwezvinodiwa zvakajairwa, uye inoongorora nguva nenguva yekutevera mafekitori ekuongorora kuti ive nechokwadi chekuenderana.ETL yanga iripo kweanopfuura zana. makore.Mavara matatu ETL mapfupi eElectrical Testing Labs akavambwa nemuvambi VaEdison muna 1896.ETL inomiririra hunyanzvi, simba, kuzvimiririra.nt uye yakavhurika chigadzirwa kuyedzwa uye ruzivo rwakapfuma.ETLus certification (isu chete, kwete c): cETL certification (chete c, kwete isu) : cETlus certification (chete c, kwete isu) : cETlus certification (chete c, kwete isu) : cETlus certification (chete c, kwete isu) : cETlus certification (chete c, kwete isu) Kana uine zvese, unowana ka4 pagore.
Zvigadzirwa zvemagetsi zvine ionizing mwaranzi
- TV uye vhidhiyo inoratidzwa muCRT yekuratidzira modhi
Zvigadzirwa zvemagetsi zvine-non-ionizing radiation
Microwave oveni, mwenje wezuva uye zvigadzirwa zvemwenje wezuva (zuva) isina-cellular foni-laser zvigadzirwaKusanganisira laser pointer, laser, laser kuratidza ine laser unit zvigadzirwa (CD player, DVD, cd-rom, laser printers, nezvimwewo), Kuchengeteka uye zvigadzirwa zvekununura-deko rekudzivirira remidziyo yeX-ray (yakadai seX-ray yekuongorora masisitimu, X-ray imaging system, X-ray kuchengetedza yekuongorora system, X-ray luggage inspection system)
Maindasitiri uye zvigadzirwa zvekutsvaga
Laser maturusi nemalaser instrumentsnon-yliao diagnostic X-ray equipment-radiofrequency and microwave products (non-microwave ovens) non-diagnostic and therapeutic ultrasound productsfda ine marudzi maviri emitemo yezvokudya, zvinodhaka, uye midziyo: kubvumirwa uye kuzivisa.
Medical product management classification
Giredhi I rudzi urwu rwechigadzirwa ruchava nengozi shoma kumushandisi, dhizaini yacho inowanzo kuve nyore pane kirasi II uye III nhanho, senge 47% enemas Yliao zvigadzirwa ndezvaiyi nhanho, 95% yavo haidi mirairo manejimendi kirasi II. Zvizhinji zveYliao zvigadzirwa ndezvekirasi II, ndezvekirasi II zvigadzirwa zvakaverengerwa 43%, semagetsi wiricheya vakadzi vane pamuviri vanopa nhanho III iyi nhanho yezvigadzirwa zvinowanzo shandiswa kuchengetedza kana hupenyu hwake, mukushandiswa kunogona kukonzera kukuvadza kana kukuvadza kuvanhu. , senge: isa cardiac pacing mazamu maimplants, nezvimwewo, ne 10% yezvigadzirwa zveYliao ndezvechikamu III chekirasi I, 95% iyo ndeyekusunungurwa Yliao equipment management, haidi kubata chiziviso pamberi pezvigadzirwa pamusika. (chiziviso) kana rezinesi (clearance) asi kune vanogadzira muFDA agency kunyoresa zvimiro, inonyora zvigadzirwa zvikuru zverudzi urwu rwekutonga senge artificial stethoscope, mercury thermometer, sit application, nezvimwe.
Nhanganyaya kune FDA certification yeradiation-inoburitsa (isiri-nyukireya) zvigadzirwa zvemagetsi
Mazhinji eakaunzwa kunze kwenyika FDA manejimendi muUnited States FOOD NEDRUG vagadziri vanoziva cosmetics Yliao midziyo yeane chiremera, asi dzimwe nguva vanhu vazhinji vanoregeredza kuburitswa kwemagetsi eradiation (radiation inoburitsa chigadzirwa) ndeimwe yedhipatimendi yakatarwa chigadzirwa FDA standard f kuburitswa. yeradiation sosi yezvigadzirwa zvemagetsi zvechishanu canto yeFEDERAL FOOD DRUG AND COSMETIC ACT (542-531 FEDERAL FOOD, DRUG, AND COSMETIC ACT, inonzi FD&
C) kuburitswa kweanonzi radiation yezvigadzirwa zvemagetsi, kusanganisira TV antenna ine skrini yekushandisa X-ray yekuongorora X-ray michina uye microwave kana laser zvigadzirwa (senge cd-rom uye laser designator (laser pointer)) uye mazhinji e chigadzirwa chemagetsi hachizoonekwe seYliao kuburitsa radiation midziyo, asi kana mugadziri kana muparadzi akati Yliao ishande nechigadzirwa, chigadzirwa uye chinoenderana neFDA nezve Yliao midziyo yakatarwa ye congressional mutemo yakatarwa kuburitsa radiation yezvigadzirwa zvemagetsi nekushandisa zvakadaro. zvigadzirwa, chikonzero chikuru ndechekudzivirira vatengi kukanganisa hutano
Zvigadzirwa zvine hukama neLaser, semuenzaniso, kuChina chikuru chekutengesa kunze zvigadzirwa zvinoda kuenderana neiyo FDA uye zvimwe zvigadzirwa zvine optical drive zvakare mune yakatarwa, senge notebook komputa maererano neCD-rom, iyo FDA maererano saizi yeradiation yakakamurwa kuita zvikamu zvina, vatengi vese kushandisa laser optical drive ine akawanda ndeenjodzi yakaderera yekirasi yekutanga (kirasi 1) pamberi pekutanga drive pini mei, vashandisi vanofanirwa kutevedzera iyo FDA zvinotevera zvinongedzo: 1 wega. Declaration table;
2. Kunyoreswa kwechigadzirwa;
3 bvunzo zviyero;
4. Product Reports;
Mishumo Yegore;
Chirevo chegore chinozotumirwa kuFDA munaGunyana 1 gore rega rega.Kana mushumo wacho usina kugadziriswa nguva dzose, chigadzirwa chichachengetwa netsika panguva yekuregererwa kwetsika.
7 zvinyorwa zvinoenderana;
Zvigadziro pazviratidzo zveyambiro
FDA certification process
1. Kopi yerezinesi rekambani yepamutemo yemunhu panguva yekugadzirira; Kopi yekugadzira (hutsanana) rezinesi uye chitupa chekufanirwa;2.Gamuchira uye upe magwaro eshanduro echiRungu eDMF(gwaro guru remushonga) uye SOP(maitiro akajairwa ekushanda) kumumiririri;3.Ongororo yeDMF zvinhu;FDA inonyatso ongorora uye kuongorora fekitori ipapo kuti ione kana zvinyorwa zveDMF ndezvechokwadi; Kana FDA ikasawana chero kukanganisa kwezvinhu uye ichiona kuti inosangana nezvinodiwa, inozopa zano rekuongorora isati yabvumidzwa.4. FDA inspection.Kana pane kusava nechokwadi, mukuru mukuru achapa fomu 483 (chikumbiro chekugadzirisa).Kana dambudziko rakakura, mukuru wehurumende haazope fomu 483 (5). Mibvunzo isina kujeka kumuchuchisi ichatsanangurwa uye kuratidzwa.
