Ukuqeqeshwa kwe-Hitec Medical MDR – Incazelo Yemibandela ye-MDR

Idivayisi yezokwelapha

Kubhekiselwa kunoma iyiphi ithuluzi, okokusebenza, into esetshenziswayo, isofthiwe, okokufakelwa, i-reagent, impahla, noma enye into esetshenziswa kuphela noma ihlanganiswe ngumkhiqizi ngenhloso eyodwa noma ngaphezulu yezokwelapha ethile emzimbeni womuntu:

• Ukuxilongwa, ukuvimbela, ukuqapha, ukubikezela, ukubikezela, ukwelashwa noma ukuxolelwa kwezifo;
• Ukuxilongwa, ukuqapha, ukwelashwa, impumuzo, kanye nesinxephezelo sokulimala noma ukukhubazeka;
• Ucwaningo, ukufaka esikhundleni, kanye nokulawulwa kwezinqubo ze-anatomical, physiological, noma pathological pathological;
• Nikeza ulwazi ngokuhlolwa kwe-in vitro kwamasampula avela emzimbeni womuntu, okuhlanganisa izitho, igazi, nezicubu ezinikelwe;
• Ukusetshenziswa kwayo ngokuyinhloko kutholwa ngokomzimba nangezinye izindlela, hhayi nge-pharmacology, i-immunology, noma i-metabolism, noma nakuba lezi zindlela zihilelekile, zidlala indima yokusiza kuphela;
• Amadivayisi anezinjongo zokulawula noma zokusekela
• Isetshenziselwa ngokukhethekile ukuhlanza, ukubulala amagciwane, noma amathuluzi okubulala amagciwane.

Idivayisi esebenzayo

Noma iyiphi idivayisi esebenza njengomthombo wamandla ngaphandle kokuthembela emzimbeni womuntu noma amandla adonsela phansi, futhi isebenza ngokushintsha ukuminyana kwamandla noma ukuguqula amandla.Amadivayisi asetshenziselwa ukudlulisa amandla, izinto, noma ezinye izinto phakathi kwamadivayisi asebenzayo neziguli ngaphandle kwanoma yiziphi izinguquko ezibalulekile ngeke abhekwe njengamadivayisi asebenzayo.

Idivayisi ehlaselayo

Noma iyiphi idivayisi engena emzimbeni womuntu ngokusebenzisa imigudu yemvelo noma izindawo.

Iphakethe lenqubo

Inhlanganisela yemikhiqizo ehlanganiswe ndawonye futhi imakethwe ngezinjongo ezithile zezokwelapha.

Umkhiqizi

Umuntu wemvelo noma osemthethweni okhiqiza noma olungisa ngokugcwele idivayisi noma idivayisi eklanywe, ekhiqiziwe, noma evuselelwe ngokuphelele futhi ethengisa idivayisi ngaphansi kwegama layo noma uphawu lokuhweba.

Ukulungisa ngokugcwele

Ngokusekelwe encazelweni yomkhiqizi, kubhekiselwa ekulungisweni kabusha okuphelele kwamadivayisi afakwe emakethe noma asetshenziswa, noma ukusetshenziswa kwamadivayisi asetshenzisiwe ukuze kukhiqizwe amadivayisi amasha athobela lo mthetho futhi anikeze amadivayisi avuselelwe isikhathi esisha sokuphila. 

Ummeleli Ogunyaziwe

Noma yimuphi umuntu wemvelo noma osemthethweni oshiwo ngaphakathi kwe-EU othola futhi amukele ukugunyazwa okubhaliwe kumkhiqizi ongaphandle kwe-EU ukuthi athathele umkhiqizi zonke izinyathelo ngokuhambisana nezibopho ezibekwe yilo Mthethonqubo kumkhiqizi.

Umngenisi

Noma yimuphi umuntu wemvelo noma osemthethweni okhonjwe ngaphakathi kwe-European Union obeka amadivayisi asuka emazweni esithathu emakethe ye-EU.

Abasabalalisi

Noma yimuphi umuntu wemvelo noma osemthethweni kumnikezeli wempahla, ngaphandle komkhiqizi noma umngenisi, angabeka idivayisi emakethe ize iqale ukusetshenziswa.

I-Unique Device Identification (UDI)

Uchungechunge lwezinhlamvu zezinombolo noma ze-alphanumeric ezidalwe ngokuhlonzwa kwedivayisi okuqashelwa umhlaba wonke kanye namazinga okufaka amakhodi, okuvumela ukukhonjwa okucacile kwamadivayisi athile emakethe.