Isatifikethi se-UKCA sibhekisela kwimigangatho yesatifikethi ekufuneka ihlangabezane nayo xa kuthengiswa izixhobo zonyango kwiimarike zase-UK.Ngokwemigaqo yaseBritani, ukususela ngoJanuwari 1, 2023, izixhobo zonyango ezithengiswa e-UK kufuneka zihambelane neemfuno zesatifikethi se-UKCA, ezithatha indawo yesatifikethi se-CE sangaphambili.Ukufumana isatifikethi se-UKCA kufuna ukuthotyelwa kwemimiselo kunye nemigangatho karhulumente waseBrithani kunye nee-arhente ezifanelekileyo, kunye nesicelo esihambelanayo kunye nenkqubo yokuhlaziya.
Yintoni isiqinisekiso se-UK Conformity Assessment (UKCA)?
Ukuqinisekiswa kwe-UKCA yinkqubo yokuthotyelwa kwezixhobo zonyango ukufumana ukufikelela kwiimarike e-United Kingdom (UK).E-UK, ukuqaliswa kwamanqaku e-UKCA kwathatha indawo ye-CE yangaphambili.Esi siqinisekiso sibalulekile ukuqinisekisa ukuba isixhobo sakho sonyango siyahambelana neemfuno ze-UK Medical Device Regulation (UK MDR).
Zeziphi izixhobo zonyango ezifuna isatifikethi se-UKCA?
Ngokomgaqo, zonke izixhobo zonyango ezinamanqanaba aphezulu okuhlelwa kufuneka zithengiswe kwimarike yase-UK kufuneka zifumane isatifikethi se-UKCA.Oku kubandakanya iimveliso ezisanda kuqaliswa kunye neemveliso esele zivunyiwe.
Izixhobo zonyango ezifuna isatifikethi se-UKCA zibandakanya kodwa azikhawulelwanga: izixhobo zonyango loxinzelelo, i-defibrillators, iimpompo zokufakelwa, i-pacemakers, izixhobo ze-laser zonyango, izixhobo ze-X-ray, njl. Nangona kunjalo, iimfuno ezithile zinokwahluka ngokusekelwe kwizinto ezifana nokuhlelwa kunye nenjongo. yesixhobo.Kucetyiswa ukuba udibane nearhente yeziqinisekiso zobungcali okanye isebe elifanelekileyo ukuze ufumane ulwazi oluchanekileyo.
Ngubani endifanele ndijonge kwisatifikethi se-UKCA?
Ukufumana isatifikethi se-UKCA sezixhobo zonyango, abavelisi kufuneka banikezele umbutho wesithathu obizwa ngokuba yi-UK Approved Body ukwenza uvavanyo lokuthotyelwa kunye nesatifikethi esihlangabezana neemfuno ze-UKCA.
Ngawaphi amanyathelo afunekayo kwisiqinisekiso se-UKCA?
Inkqubo yokuqinisekiswa kwe-UKCA ibandakanya ukuhlelwa kwemveliso, ukuphononongwa koxwebhu lobugcisa, uvavanyo lwenkqubo yomgangatho kunye nesatifikethi sokugqibela.Zonke iimfuno ezifanelekileyo kufuneka zifezekiswe ukubonisa ukuthotyelwa.
Qinisekisa umda wemveliso: Qinisekisa ukuba imveliso yakho ifuna isatifikethi se-UKCA kunye nobubanzi obufunekayo besatifikethi.
Ukulungiswa kwamaxwebhu kunye novavanyo: Lungiselela amaxwebhu obugcisa bemveliso kwaye wenze uvavanyo oluyimfuneko kunye novavanyo lwemveliso ukuqinisekisa ukuthotyelwa kwemigangatho yezobugcisa ye-EU efanelekileyo.
Nikeza iqumrhu lezatifiketi: Khetha iqumrhu lezatifiketi ezivunyiweyo e-UK kwaye uliphathise ukuba livavanye kwaye liqinisekise iimveliso zakho.
Yenza uphononongo: Iqumrhu lezatifiketi liya kuqhuba uvandlakanyo lwemveliso, kubandakanywa uphononongo lwamaxwebhu kunye novavanyo olunokwenzeka kwisiza.
Ukukhutshwa kwesatifikethi: Ukuba imveliso ihlangabezana neemfuno, iqumrhu lokuqinisekisa liya kukhupha isatifikethi se-UKCA.
Ngawaphi amanqaku exesha ekufuneka uwahoye ukuze ufumane isatifikethi se-UKCA?
Urhulumente wase-Bhritane wenze amalungiselelo enguqu kwisatifikethi se-UKCA.Kwizixhobo zonyango, lo mhla wokugqibela wandiswa kwakhona ngoJulayi 2023. Ixesha lokuqinisekisa lixhomekeke kuhlelo lwesixhobo sonyango kunye nohlobo lwesatifikethi se-EU.
Oku kuthetha ukuba abavelisi bezixhobo zonyango banokubeka iimveliso zabo kwimarike yase-UK besebenzisa zombini i-UKCA kunye nokumakishwa kwe-CE ngaphambi komhla ochaziweyo.Kuyacetyiswa ukuba ufake isicelo sesatifikethi se-UKCA kwangethuba ukuze uqinisekise ufikelelo ngexesha elifanelekileyo kwaye uphephe ukulibaziseka.
Ixesha lokuposa: Dec-28-2023