Ukuhlukaniswa okufanele komkhiqizo wakho wezokwelapha kuyisisekelo sokungena emakethe, Ukwazi ukuthi idivayisi yakho yezokwelapha ihlukaniswa ngezigaba kubaluleke kakhulu ngoba:
-Ukuhlukaniswa komkhiqizo kuzonquma ukuthi yini okudingeka uyenze ngaphambi kokuthi uthengise umkhiqizo wakho ngokusemthethweni.
-Ukuhlelwa kuzokusiza ukuthi uthole izidingo ngesikhathi sesigaba sokuthuthukiswa komkhiqizo, ikakhulukazi izilawuli zokuklama.nokuthi ungene kanjani emakethe yakho.
-Ukuhlukaniswa kuyingxenye ebalulekile ekunqumeni ukuthi uzotshala malini ukuze ufake idivayisi yakho ukuze umakethe ngokusemthethweni futhi ikunikeze umbono ongemuhle wokuthi kuzothatha isikhathi esingakanani.
Ngenxa yalokhu, ngizokunikeza isiqondiso esincane ukuze uqonde kangcono okufanele ukwenze nokuthi ukwenze kanjani.
Okuqukethwe okulandelayo akuwona umhlahlandlela ophelele wokuhanjiswa okulawulwayo, kodwa kufanele kukunikeze isiqondiso esiyisisekelo nesiqondiso sendlela yokukuhlukanisa.
Lapha sizoklelisa “izimakethe ezi-3 eziyinhloko” njengoba ngezansi:
1.US Food & Drug Administration, Center for Devices & Radiological Health (FDA CDRH);I-US FDA ihlukanisa amadivayisi ezokwelapha ngezigaba ezintathu - Ikilasi I, II, noma III - ngokusekelwe ezingozini zabo kanye nezilawuli zokulawula ezidingekayo ukuze kuhlinzekwe isiqiniseko esiphusile sokuphepha nokusebenza kahle.ngokwesibonelo ithemometha yedijithali kanye ne-infrared thermometer zihlukaniswa ngokwesigaba II.
2.Ikhomishana yaseYurophu, ngokusho kwe-Journal esemthethweni ye-European Union Regulation (EU) MDR 2017/745 Annex VIII, ngokususelwe esikhathini sokusetshenziswa, idivayisi ehlaselayo/engahlaseli, esebenzayo noma engasebenzi, amathuluzi akusigaba I, isigaba IIa, Ikilasi IIb kanye nekilasi III.Isibonelo imonitha yomfutho wegazi engaphezulu kwengalo yedijithali nesitayela sesihlakala yiClass IIa.
3.I-China National Medical Products Administration, ngokweMithetho yokuqondisa nokuphathwa kwemishini yezokwelapha(NO. 739 yoMkhandlu Wombuso), ngokusekelwe engcupheni yemishini yezokwelapha, ihlukaniswa ngamaleveli angu-3, isigaba I, isigaba II kanye class III.futhi i-China NMPA ikhiphe uhla lwemibhalo lokuhlukanisa idivayisi yezokwelapha futhi lubuyekezwa ngezikhathi ezithile.Isibonelo i-stethoscope yikilasi I, izinga lokushisa kanye nokuqapha komfutho wegazi kuyikilasi II.
Ngenqubo yokuhlukanisa enemininingwane kanye nendlela yokuhlukanisa amanye amazwe, kufanele sithobele imithetho nesiqondiso esihlobene.
Isikhathi sokuthumela: Feb-13-2023