Njengoba isidingo somhlaba wonke samadivayisi ezokwelapha alahlwayo asezingeni eliphezulu siqhubeka nokukhula, izinhlangano ezilawulayo eYurophu nase-United States ziqinisa izidingo zokuthobela imithetho—ikakhulukazi amasirinji nezinto zokuqoqa igazi. Lawa mathuluzi abalulekile ezokwelapha angaphansi kokuhlolwa okukhulu ngenxa yokusetshenziswa kwawo kabanzi ekuxilongeni, ekugomeni nasekunakekeleni iziguli.
Kubakhiqizi, abangenisa impahla kwamanye amazwe, kanye nabasabalalisi, ukuqonda lezi zindinganiso ezishintshayo akukhona nje ukuhlangabezana nezidingo zomthetho—kuyisihluthulelo sokuqinisekisa ukuphepha komkhiqizo, ukuthuthukisa ukufinyelela emakethe, kanye nokwakha ukwethembeka kwesikhathi eside.
Ukugxila Okuqinile Ekuphepheni Nokulandelela
Ku-European Union kanye nase-United States, ukuphepha kweziguli yikona okubangela izinguquko ezintsha zomthetho. Isibonelo, i-EU's Medical Device Regulation (MDR), eyathatha indawo ye-MDD yangaphambilini ngo-2021, igcizelela ukuhlolwa okuphelele kwemitholampilo, ukuhlolwa kwezingozi, kanye nokuqapha ngemuva kwemakethe.
E-US, i-FDA's 21 CFR Part 820 (Quality System Regulation) iyaqhubeka nokusebenza njengesisekelo sezindinganiso zokukhiqiza. Kodwa-ke, izibuyekezo ezizayo ezihambisana ne-ISO 13485 zizogxila kakhulu ekulandeleni nasekubhaleni imibhalo—ikakhulukazi kumadivayisi e-Class II afana namasirinji namapayipi okuqoqwa kwegazi.
Kusho ukuthini lokhu kubahlinzeki? Zonke izigaba zochungechunge lokuhlinzeka—kusukela ekukhetheni izinto zokusetshenziswa kuya ekupakisheni—manje kumele zilandelelwe futhi ziqinisekiswe.
Ukugcizelelwa Kokuhambisana Kwezinto Eziphilayo kanye Nokuqinisekiswa Kokungazali
Njengoba kukhushulwa ukukhathazeka mayelana nokusabela kweziguli kanye nezingozi zokungcola, ukuhlolwa kokuhambisana kwezinto eziphilayo akusadingeki. Abalawuli baseYurophu nabase-US badinga ukuhlolwa okujulile ngaphansi kwezindinganiso ze-ISO 10993 ukuqinisekisa ukuthi izinto ezisetshenziswa kuma-syringe, ama-lancet, nama-tubes ziphephile ukuthintana nabantu.
Ngaphezu kwalokho, izinqubo zokubulala amagciwane (njenge-ethylene oxide noma i-gamma irradiation) kumele zihlangabezane nezimfuneko zokuqinisekiswa ezichazwe ku-ISO 11135 noma ku-ISO 11137, ngokulandelana. Ukuqinisekiswa kokubulala amagciwane kubaluleke kakhulu emikhiqizweni egcwaliswe kusengaphambili noma esetshenziswa ekuqoqweni kwegazi ngqo.
Kubathengi bezokwelapha kanye nabangenisi, lokhu kusho ukuthi ukukhetha abahlinzeki abanganikeza imibiko yokuzala ebhalwe phansi kanye nezinqubo eziqinisekisiwe kubaluleke kakhulu kunanini ngaphambili.
Izinto Ezinakekela Imvelo Nezidingo Zokupakisha Ezisimeme
Eminyakeni yamuva nje, ukusimama kuye kwashintsha kusuka emyalezweni wokumaketha kuya ekulindelweni komthetho. I-EU ikhuthaza ngenkuthalo ukunciphisa amapulasitiki asetshenziswa kanye kanye nezinto eziyingozi emvelweni. Nakuba imikhiqizo yezokwelapha ivame ukukhululwa ekuvinjelweni, kunengcindezi ekhulayo yokusebenzisa izinto ezingasetshenziswa kabusha noma ezisekelwe ku-bio lapho kungenzeka khona.
Ngokufanayo, imakethe yase-US—ikakhulukazi phakathi kwamanethiwekhi amakhulu okuthengwa kwezempilo—iya ngokuya ihlola imikhiqizo ngokusekelwe kulokho ekwenzayo emvelweni. Ukupakisha okunciphisa imfucuza, noma amadivayisi enziwe ngezinto ezingenayo i-BPA kanye ne-DEHP, sekuba yizintandokazi ezijwayelekile.
Kubakhiqizi bezinto zokuqoqa igazi kanye nesirinji, ukuzivumelanisa nalokhu okulindelwe ngeke nje kuhlangabezane nokuhambisana nemithetho—kodwa futhi kuzothuthukisa ukuncintisana.
Ukubaluleka Kokuqopha Ngokunembile Nokuhambisana Nemithetho Ye-UDI
Izinhlangano ezilawulayo zicindezela ukunemba kokulebula. I-EU MDR kanye ne-US FDA zombili zidinga ukuthi imikhiqizo ibe ne-Unique Device Identifiers (UDI) ephrintiwe ngokucacile, izinsuku zokuphelelwa yisikhathi, izinombolo ze-batch, kanye nolimi lwendawo lwezimakethe lapho ithengiswa khona.
Ukwehluleka ukuhlangabezana nalezi zindinganiso kungabangela ukubambezeleka kwentela, ukubuyiselwa emuva, noma ukulahlekelwa ukufinyelela emakethe. Ukukhetha inqubo yokupakisha nokulebula esekela izidingo zomthetho zokulebula kuyisinyathelo esibalulekile ekuqinisekiseni imisebenzi yokungenisa/yokuthumela ngaphandle ebushelelezi.
Ukuzulazula Imithetho Ngokuzethemba
Ukuzulazula endaweni yokulawula eyinkimbinkimbi eYurophu nase-US kudinga okungaphezu nje kokuthobela imithetho eyisisekelo—kudinga ukulungiselela kusengaphambili, ukuqinisekiswa komkhiqizo okuqhubekayo, kanye nokunaka kakhulu izitayela ezintsha.
Kubathengi, abangenisa kwamanye amazwe, kanye nabahlinzeki bezempilo ngokufanayo, ukuhlala unolwazi ngemithetho yakamuva yesirinji kanye nezinto zokuqoqa igazi kubalulekile ekwenzeni izinqumo zokuthola igazi ngokuhlakanipha.
Ufuna ukuqinisekisa ukuthi imikhiqizo yakho yezokwelapha elahlwayo ihlangabezana nezindinganiso zomthetho zomhlaba wonke? Xhumana ne-Sinomed namuhla futhi uhlole ukuthi izixazululo zethu zisekela kanjani imigomo yakho yokuthobela imithetho kanye nekhwalithi.
Isikhathi sokuthunyelwe: Juni-23-2025
