Njengoba isidingo somhlaba wonke samadivayisi ezokwelapha alahlwayo aqhubeka sikhula, izindikimba ezilawulayo eYurophu nase-United States ziqinisa izimfuneko zokuthobelana—ikakhulukazi amasirinji nezinto ezisetshenziswayo zokuqoqwa kwegazi. Lawa mathuluzi ezokwelapha abalulekile abhekwa kakhulu ngenxa yokusetshenziswa kwawo kabanzi ekuxilongeni, ekugomeni nasekunakekeleni isiguli.
Kubakhiqizi, abangenisa kwamanye amazwe, nabasabalalisi, ukuqonda lawa mazinga athuthukayo akukhona nje ukuhlangabezana nezimfuneko ezingokomthetho—kubalulekile ekuqinisekiseni ukuphepha komkhiqizo, ukuthuthukisa ukufinyelela ezimakethe, nokwakha ukwethembeka kwesikhathi eside.
Ukugxila Okuqinile Kwezokuphepha Nokulandeleka
Kuzo zombili i-European Union nase-United States, ukuphepha kwesiguli kungumshayeli oyinhloko obangela izinguquko ezintsha zokulawula. Isibonelo, i-EU's Medical Device Regulation (MDR), ethathe indawo ngokuphelele ye-MDD yangaphambilini ngo-2021, igcizelela ukuhlolwa komtholampilo okuphelele, ukuhlolwa kobungozi, nokugadwa kwangemva kwemakethe.
E-US, i-FDA's 21 CFR Part 820 (Quality System Regulation) iyaqhubeka nokusebenza njengesisekelo samazinga okukhiqiza. Kodwa-ke, izibuyekezo ezizayo eziqondaniswe ne-ISO 13485 zizogxila kakhulu ekulandeleleni nasekubhalweni—ikakhulukazi kumadivayisi e-Class II njengamasirinji namashubhu okuqoqa igazi.
Kusho ukuthini lokhu kubahlinzeki? Zonke izigaba ze-supply chain—kusuka ekukhethweni kwezinto ezingavuthiwe ukuya ekupakishweni—manje kufanele zilandeleke futhi ziqinisekiseke.
Ukugcizelelwa kokuthi I-Biocompatibility kanye Nesiqiniseko Sokuzala
Ngokukhathazeka okukhulayo mayelana nokusabela kwesiguli kanye nobungozi bokungcola, ukuhlolwa kwe-biocompatibility akusakhethwa. Abalawuli baseYurophu nabase-US badinga ukuhlolwa okujulile ngaphansi kwamazinga e-ISO 10993 ukuze kuqinisekiswe ukuthi izinto ezisetshenziswa kumasirinji, ama-lancets, namashubhu ziphephile ukuthintana nabantu.
Ukwengeza, izinqubo zokuvala inzalo (ezifana ne-ethylene oxide noma i-gamma irradiation) kufanele zihlangabezane nezimfuneko zokuqinisekisa ezishiwo ku-ISO 11135 noma ISO 11137, ngokulandelanayo. Ukuqinisekisa ubunyumba kubaluleke kakhulu emikhiqizweni egcwaliswe ngaphambili noma esetshenziswa ekuqoqweni kwegazi okuqondile.
Kubathengi bezokwelapha nabangenisayo, lokhu kusho ukukhetha abahlinzeki abangahlinzeka ngemibiko ebhaliwe yokungabi namagciwane kanye nezinqubo eziqinisekisiwe kubaluleke kakhulu kunangaphambili.
Izinto Ezisetshenziswayo Zokuqaphela Imvelo Nezimfuneko Zokupakisha Ezisimeme
Eminyakeni yamuva nje, ukusimama kusuke kumlayezo wokumaketha kuya ekulindelweni ngokomthetho. I-EU ikhuthaza ngenkuthalo ukuncishiswa kwamapulasitiki asetshenziswa kanye kanye nezinto ezilimaza imvelo. Nakuba imikhiqizo yezokwelapha ivamise ukukhululeka ekuvinjelweni, kunengcindezi ekhulayo yokusebenzisa izinto ezigaywa kabusha noma ezisekelwe ku-bio noma kuphi lapho kungenzeka khona.
Ngokunjalo, imakethe yase-US—ikakhulukazi phakathi kwamanethiwekhi amakhulu okuthengwa kwempahla yezempilo—iya ngokuya ihlola imikhiqizo ngokususelwa endaweni yayo yemvelo. Ukupakishwa okwehlisa udoti, noma amadivaysi enziwe ngezinto ezibonakalayo ezingenazo i-BPA kanye ne-DEHP, aphenduka izintandokazi ezijwayelekile.
Kubakhiqizi bezinto ezidliwayo zokuqoqwa kwegazi namasirinji, ukuzivumelanisa nalokhu okulindelekile ngeke nje kuhlangabezane nokuhambisana—kodwa kuzothuthukisa ukuncintisana.
Ukubaluleka Kokulebula Okunembile kanye Nokuthobelana ne-UDI
Izindikimba ezilawulayo zephula ukunemba kokulebula. I-EU MDR kanye ne-US FDA zombili zidinga ukuthi imikhiqizo ibe ne-Unique Device Identifiers (UDI) ephrintiwe ngokucacile, amadethi okuphelelwa yisikhathi, izinombolo zenqwaba, nokwenza ulimi kwasendaweni ezimakethe lapho kuthengiswa khona.
Ukwehluleka ukuhlangabezana nalawa mazinga kungase kubangele ukubambezeleka, ukukhumbula, noma ukulahlekelwa ukufinyelela emakethe. Ukukhetha inqubo yokupakisha nokulebula esekela izimfuneko zokulebula ezilawulayo kuyisinyathelo esibalulekile ekuqinisekiseni ukusebenza kahle kokungenisa/ukuthekelisa.
Ukuzulazula Imithetho Ngokuzethemba
Ukuzulazula endaweni eyinkimbinkimbi yokulawula e-Europe nase-US kudinga okungaphezu nje kokuthobela okuyisisekelo—kudinga ukulungiswa okumatasa, ukuqinisekiswa komkhiqizo okuqhubekayo, kanye nokunaka kakhulu izitayela ezivelayo.
Kubathengi, abangenisi, nabahlinzeki bezempilo ngokufanayo, ukuhlala unolwazi mayelana nemithetho yakamuva yamasirinji kanye nezinto ezisetshenziswayo zokuqoqwa kwegazi kubalulekile ukuze wenze izinqumo ezihlakaniphile zokuthola usizo.
Ufuna ukuqinisekisa ukuthi imikhiqizo yakho yezokwelapha elahlayo ihlangabezana nezindinganiso zokulawula zomhlaba wonke? Xhumana ne-Sinomed namuhla futhi uhlole ukuthi izixazululo zethu zisekela kanjani ukuthobela kwakho nezinjongo zekhwalithi.
Isikhathi sokuthumela: Jun-23-2025
