Isitifiketi se-UKCA sisho izindinganiso zesitifiketi okudingeka zihlangatshezwe lapho kuthengiswa imishini yezokwelapha emakethe yase-UK. Ngokwemithetho yaseBrithani, kusukela ngoJanuwari 1, 2023, imishini yezokwelapha ethengiswa e-UK kufanele ihambisane nezidingo zesitifiketi se-UKCA, esikhundleni sesitifiketi sangaphambilini se-CE. Ukuthola isitifiketi se-UKCA kudinga ukuhambisana nemithethonqubo namazinga kahulumeni waseBrithani nama-ejensi afanelekile, kanye nenqubo yokufaka isicelo kanye nokubuyekeza okuhambisanayo.
Siyini isitifiketi se-UK Conformity Assessment (UKCA)?
Isitifiketi se-UKCA yinqubo yokuthobelana yamadivayisi ezokwelapha ukuze athole ukufinyelela emakethe e-United Kingdom (UK). E-UK, ukwethulwa kwe-UKCA mark kuthathe indawo ye-CE yangaphambilini. Lesi sitifiketi sibalulekile ukuze uqinisekise ukuthi idivayisi yakho yezokwelapha ithobelana nezidingo ze-UK Medical Device Regulation (UK MDR).
Yiziphi izisetshenziswa zezokwelapha ezidinga isitifiketi se-UKCA?
Empeleni, wonke amadivaysi ezokwelapha anamazinga aphezulu okuhlukaniswa azothengiswa emakethe yase-UK adinga ukuthola isitifiketi se-UKCA. Lokhu kuhlanganisa imikhiqizo esanda kwethulwa kanye nemikhiqizo esivele igunyaziwe.
Imishini yezokwelapha edinga isitifiketi se-UKCA ihlanganisa kodwa ayikhawulelwe kulokhu: okokusebenza kokwelapha ngokucindezela, ama-defibrillator, amaphampu afakwayo, ama-pacemaker, okokusebenza kwelaser yezokwelapha, okokusebenza kwe-X-ray, njll. Nokho, izidingo ezithile zingase zihluke ngokusekelwe ezicini ezifana nokuhlukaniswa nenjongo. kwedivayisi. Kunconywa ukuthi uthintane ne-ejensi yezitifiketi eziqeqeshiwe noma umnyango ofanelekile ukuze uthole ulwazi olunembe kakhudlwana.
Ubani okufanele ngimbheke ukuze ngithole isitifiketi se-UKCA?
Ukuze bathole isitifiketi se-UKCA semishini yezokwelapha, abakhiqizi badinga ukuphathisa inhlangano yezinkampani zangaphandle ebizwa ngokuthi i-UK Approved Body ukuthi yenze ukuhlola ukuthobelana nesitifiketi esihlangabezana nezimfuneko ze-UKCA.
Yiziphi izinyathelo ezidingekayo ukuze uthole isitifiketi se-UKCA?
Inqubo yesitifiketi se-UKCA ihlanganisa ukuhlukaniswa komkhiqizo, ukubuyekezwa kwedokhumenti yobuchwepheshe, ukuhlolwa kwesistimu yekhwalithi kanye nesitifiketi sokugcina. Zonke izidingo ezifanele kufanele kuhlangatshezwane nazo ukuze kuboniswe ukuhambisana.
Nquma ububanzi bomkhiqizo: Thola ukuthi ingabe umkhiqizo wakho udinga isitifiketi se-UKCA kanye nobubanzi obudingekayo besitifiketi.
Ukulungiswa kwamadokhumenti nokuhlola: Lungiselela imibhalo yezobuchwepheshe yomkhiqizo futhi wenze ukuhlolwa okudingekayo nokuhlolwa komkhiqizo ukuze uqinisekise ukuthobelana nezindinganiso zobuchwepheshe ze-EU.
Nikeza indikimba yezitifiketi: Khetha inhlangano yezitifiketi egunyazwe e-UK futhi uyiphathise ukuthi ihlole futhi iqinisekise imikhiqizo yakho.
Yenza ukuhlola: Inhlangano enikeza izitifiketi izohlola umkhiqizo, okuhlanganisa nokubuyekezwa kwemibhalo kanye nokuhlola okungenzeka endaweni.
Ukukhishwa kwesitifiketi: Uma umkhiqizo uhlangabezana nezidingo, indikimba yezitifiketi izokhipha isitifiketi se-UKCA.
Yimaphi amaphuzu esikhathi okudingeka uwanake ukuze uthole isitifiketi se-UKCA?
Uhulumeni waseBrithani usebenzise izinhlelo zesikhashana zokuthola isitifiketi se-UKCA. Kumadivayisi ezokwelapha, lo mnqamulajuqu waphinda welulwa ngoJulayi 2023. Isikhathi sokuqinisekisa sincike ekuhlukaniseni idivayisi yezokwelapha kanye nohlobo lwesitifiketi se-EU.
Lokhu kusho ukuthi abakhiqizi bemishini yezokwelapha bangabeka imikhiqizo yabo emakethe yase-UK besebenzisa kokubili izimpawu ze-UKCA ne-CE ngaphambi kosuku olushiwo. Kutuswa ukuthi ufake isicelo sesitifiketi se-UKCA kusenesikhathi ukuze uqinisekise ukufinyelela ezimakethe ngesikhathi futhi ugweme ukubambezeleka.
Isikhathi sokuthumela: Dec-28-2023