Imikhiqizo ye-orthodontic eqinisekiswe yi-CE idlala indima ebalulekile ekunakekelweni kwamazinyo kwesimanje ngokuqinisekisa ukuphepha nekhwalithi. Le mikhiqizo ihlangabezana nezindinganiso eziqinile ze-European Union, iqinisekisa ukuthembeka kwayo kokubili ezigulini nakubachwepheshe. I-EU Medical Device Regulation (MDR) yethule izidingo eziqinile zokuthuthukisa ukuphepha kweziguli. Isibonelo:
- Izinsimbi zamazinyo kumele zibe khona manjekulandelelwa inqubo yabo yokubulala inzalo.
- Odokotela bamazinyo abasebenzisa ubuchwepheshe be-CAD/CAM babhekene nezibopho ezengeziwe zokuthobela imithetho, okuhlanganisa nezinhlelo zokulawula izingozi.
Ukuhambisana nalezi zindinganiso kuvikela iziguli futhi kuqinisekisa ukuthi imitholampilo yamazinyo iyahlangabezana nemithwalo yemfanelo esemthethweni, okukhuthaza ukwethembana kanye nobungcweti kulo mkhakha.
Izinto Ezibalulekile Okufanele Uzicabangele
- Isitifiketi se-CE sibonisa ukuthi imikhiqizo ye-orthodontic iphephile futhi isezingeni eliphezulu.
- Imitholampilo yamazinyo kufanele ihlole amalebula futhi icele amadokhumenti okuqinisekisa isitifiketi se-CE.
- Ukuhlolwa okuvamile kusiza imitholampilo ukuthola izinkinga nokulandela imithetho ye-EU MDR ukuze kugcinwe iziguli ziphephile.
- Ukuthenga kubahlinzeki abathembekile kunciphisa izingozi futhi kuthuthukisa ukunakekelwa kweziguli.
- Ukufundisa abasebenzi ngemithetho ye-EU MDR kusiza wonke umuntu ukuthi azi ukuthi angazigcina kanjani izinto ziphephile futhi zisezingeni eliphezulu.
Iyini Imikhiqizo Ye-Orthodontic Eqinisekiswe yi-CE?
Incazelo kanye nenhloso yesitifiketi se-CE
Isitifiketi se-CE siwuphawu lwekhwalithi nokuphepha okuqashelwa kulo lonke i-European Union. Sisho ukuthi umkhiqizo uhambisana nemithetho ye-EU, okuqinisekisa ukuthi uhlangabezana nezindinganiso zezempilo, ukuphepha, kanye nokuvikelwa kwemvelo. Ngemikhiqizo ye-orthodontic, lesi sitifiketi siqinisekisa ukuthi iphephile ezigulini futhi isebenza kahle ekusetshenzisweni kwayo okuhlosiwe. Imitholampilo yamazinyo ithembele emikhiqizweni ye-orthodontic eqinisekiswe yi-CE ukuze igcine amazinga aphezulu okunakekelwa futhi yakhe ukwethembana neziguli zayo.
Inhloso yesitifiketi se-CE idlulela ngale kokuthobela imithetho. Iphinde ikhuthaze ukuhambisana kwekhwalithi yomkhiqizo emakethe ye-EU. Lokhu kuqinisekisa ukuthi imikhiqizo ye-orthodontic, njengezibiyeli nezintambo, isebenza ngokuthembeka kungakhathaliseki ukuthi yenziwa noma isetshenziswa kuphi.
Inqubo Yokuqinisekisa Isitifiketi se-CE Yemikhiqizo Ye-Orthodontic
Inqubo yokuqinisekiswa kwe-CE yemikhiqizo ye-orthodontic ihilela izinyathelo eziningana ezibalulekile. Abakhiqizi kumele kuqalaqonda izidingo ezithile zemakethe, okuhlanganisa nesidingo sokumaka i-CE e-EU. Kumelwe baqinisekise ukuthi imikhiqizo yabo ihlangabezana nezindinganiso zokuphepha nokusebenza ezibalulekile ezichazwe ku-EU Medical Device Regulation (MDR). Ukubambisana nezinhlangano zokuhlola ezigunyaziwe ezivela eceleni kubalulekile ekuhlolweni okuqinile kokuhambisana komkhiqizo kanye nekhwalithi yawo.
Ukuhlala unolwazi ngezinguquko zomthetho kungenye isici esibalulekile sale nqubo. Izincwadi zemboni kanye nochwepheshe bezomthetho banikeza ukuqonda okubalulekile mayelana nezikhathi zokuthobela imithetho kanye nezindinganiso ezishintshayo. Uma umkhiqizo udlula zonke izilinganiso, uthola uphawu lwe-CE, okubonisa ukulungela kwawo imakethe ye-EU.
Izibonelo zemikhiqizo ye-Orthodontic eqinisekiswe yi-CE
Imikhiqizo ye-orthodontic eqinisekiswe yi-CE ihlanganisa amathuluzi namadivayisi ahlukahlukene asetshenziswa emitholampilo yamazinyo. Izibonelo zifaka phakathi ama-bracket e-orthodontic, izintambo ze-arch, kanye nama-aligners. Le mikhiqizo ihlolwa ngokuqinile ukuqinisekisa ukuthi ihlangabezana nezindinganiso eziphakeme kakhulu zokuphepha nokusebenza. Isibonelo, ama-bracket e-orthodontic akhiqizwa yizinkampani ezifana ne-Denrotary Medical akhiqizwa kusetshenziswa imishini ethuthukisiwe futhi alandela izinyathelo eziqinile zokulawula ikhwalithi. Lokhu kuqinisekisa ukuthi ochwepheshe bamazinyo bangathembela kule mikhiqizo ukuze banikeze ukwelashwa okusebenzayo nokuphephile ezigulini zabo.
Ukuqonda Izindinganiso ze-EU MDR
Izidingo Eziyinhloko ze-EU MDR Yemikhiqizo Ye-Orthodontic
Umthetho Wedivayisi Yezokwelapha we-EU (MDR), owaziwa ngokusemthethweni ngokuthiI-EU 2017/745, isungula uhlaka oluphelele lokulawula amadivayisi ezokwelapha, okuhlanganisa nemikhiqizo ye-orthodontic. Lo mthetho waba yimpoqo kuwo wonke amazwe e-EU ngoMeyi 2021. Uhlose ukuthuthukisa ukuphepha, ukusekela ukusungula izinto ezintsha, nokuqinisekisa ikhwalithi ehambisanayo.
Izidingo ezibalulekile zifaka:
- Akukho Umthetho Wokuba Umkhulu: Amadivayisi avunyelwe ngaphansi kwe-Medical Device Directive (MDD) yangaphambilini kumele ahlolwe kabusha ukuze ahlangabezane nezindinganiso ze-MDR.
- Isihlonzi Sedivayisi Esiyingqayizivele (i-UDI): Yonke imikhiqizo ye-orthodontic kumele ifake i-UDI ukuze kulandeleke kangcono.
- Ukulawulwa Kokubulala Inzalo: Amathuluzi amazinyo kumele abonise ukuthi alandeleka kahle ezinqubweni zawo zokubulala amagciwane.
Lezi zimfuneko ziqinisekisa ukuthi imikhiqizo ye-orthodontic ihlangabezana nezindinganiso zokuphepha eziqinile kanye nokusebenza kahle, okuvikela iziguli kanye nodokotela ngokufanayo.
Indlela i-EU MDR Eqinisekisa Ngayo Ukuphepha Nokusebenza
I-EU MDR ithuthukisa ukuphepha nokusebenza ngezinyathelo eziqinile zokulawula. Abakhiqizi kumele banikeze ubufakazi bezokwelapha ukuze babonise ukuphepha nokusebenza kahle kwemikhiqizo yabo. Lokhu kuhlanganisa nokubhala phansi yonke imijikelezo yokuphila kwedivayisi.
Lo mthethonqubo uphinde uphoqeleleUhlelo Lokuphatha Ikhwalithi (i-QMS)kanye nohlelo Lokuqapha Ngemva Kwemakethe (PMS). Lezi zinhlelo ziqapha ukusebenza komkhiqizo futhi zibhekane nezingozi ezingaba khona. Isibonelo, imikhiqizo ye-orthodontic kumele ihambisane nezindinganiso ze-ISO 14971:2019 zokuphathwa kwengozi. Ngokudinga lezi zinyathelo, i-EU MDR inciphisa amathuba ezenzakalo ezimbi, njengalezo ezibonwe kumahlazo emishini yezokwelapha edlule.
Izibuyekezo Zakamuva Emitholampilo Yamazinyo Ethinta I-EU MDR
Izibuyekezo eziningana ku-EU MDR zithinta ngqo imitholampilo yamazinyo. Ushintsho oluvela ku-MDD luye ku-MDR, oluqale ukusebenza ngoMeyi 2021, ludinga ukuthi wonke amadivayisi avunyelwe ngaphambilini ahlolwe kabusha ngoMeyi 2024. Lokhu kuqinisekisa ukuhambisana nezindinganiso zakamuva.
Ukwethulwa kohlelo lwe-UDI kuthuthukisa ukulandeleka komkhiqizo, ikakhulukazi kumadivayisi afakelwa eSigaba III. Ngaphezu kwalokho, odokotela bamazinyo abasebenzisa ubuchwepheshe be-CAD/CAM manje sebehlukaniswa njengabakhiqizi. Kumelwe basebenzise izinhlelo zokuphatha ikhwalithi futhi bahambisane nezibopho ze-MDR.
Isizindalwazi se-EUDAMED simele esinye isibuyekezo esibalulekile. Le nkundla iqoqa futhi icubungule ulwazi mayelana namadivayisi ezokwelapha, ithuthukisa ukucaca kanye nokugeleza kolwazi. Lezi zinguquko zigcizelela ukubaluleka kokuthobela imithetho yemitholampilo yamazinyo esebenzisa i-CE-Certified Orthodontic Products.
Kungani Ukuthobela Imithetho Kubalulekile Emitholampilo Yamazinyo
Izingozi Zokungalandeli i-EU MDR
Ukungalandeli izindinganiso ze-EU MDR kubeka izingozi ezinkulu emitholampilo yamazinyo. Ukwephulwa kwemithetho kungaholela emiphumeleni emibi yezomthetho, okuhlanganisa izinhlawulo, izinhlawulo, noma ngisho nokumiswa kokusebenza. Imitholampilo ingabhekana nomonakalo wedumela, okungaqeda ukwethenjwa kwesiguli futhi kuthinte impumelelo yesikhathi eside. Ngaphezu kwalokho, ukusebenzisa imikhiqizo ye-orthodontic engahambisani nomthetho kwandisa amathuba emicimbi emibi, njengokwehluleka kwedivayisi noma ukulimala kwesiguli, okungaholela ezinkantolo ezibizayo.
Ukwehluleka ukuhlangabezana nezidingo ze-EU MDR kungaphazamisa nokusebenza kwemitholampilo. Isibonelo, ukungabikho kwe-Unique Device Identifier (UDI) emikhiqizweni ye-orthodontic kungavimbela ukulandelelwa, kwenze kube nzima ukuphathwa kwempahla kanye nokunakekelwa kweziguli. Imitholampilo engayinaki ukusebenzisa uhlelo lwe-Quality Management System (QMS) noma uhlelo lwe-Post-Market Surveillance (PMS) ingase ibe nobunzima bokubhekana nezinkinga zokuphepha ngempumelelo, okuyenza ibonakale isengozini yokuhlolwa kwemithetho.
Izinzuzo Zokusebenzisa Imikhiqizo Ye-Orthodontic Eqinisekiswe yi-CE
Ukusebenzisa i-CE-Certified Orthodontic Products kunikeza izinzuzo eziningi emitholampilo yamazinyo. Le mikhiqizo ihlangabezana nezindinganiso zokuphepha eziqinile kanye nokusebenza kahle, iqinisekisa ukwelashwa okuthembekile nokuphumelelayo. Iziguli ziyazuza emiphumeleni ethuthukisiwe, kuyilapho imitholampilo ithola idumela lokunakekelwa kwekhwalithi. Isitifiketi se-CE senza kube lula ukuhambisana nezidingo ze-EU MDR, kunciphisa umthwalo wokuphatha emitholampilo.
Imitholampilo ebeka phambili imikhiqizo eqinisekiswe yi-CE ingenza kube lula ukusebenza kwayo. Isibonelo, ukulandeleka kwale mikhiqizo kuthuthukisa ukuphathwa kwempahla futhi kusekela ukulawulwa kokubulala amagciwane. Lokhu kuqinisekisa ukuthi zonke izinsimbi ziyahlangabezana nezindinganiso zokuhlanzeka, kunciphisa ingozi yokutheleleka. Ngaphezu kwalokho, imikhiqizo eqinisekiswe yi-CE ivame ukuza nemibhalo ephelele, okwenza kube lula ngemitholampilo ukugcina ukuthobela imithetho.
Imithwalo Yemfanelo Yezomthetho Neyokuziphatha Yemitholampilo Yamazinyo
Imitholampilo yamazinyo inezibopho zomthetho nezokuziphatha zokuhambisana nezindinganiso ze-EU MDR. Ngokomthetho, imitholampilo kumele iqinisekise ukuthi wonke amadivayisi ezokwelapha, okuhlanganisa nemikhiqizo ye-orthodontic, ahlangabezana nezidingo zomthetho. Lokhu kufaka phakathi:ukusebenzisa izilawuli zangaphakathi, ukwenza ukuhlolwa njalo, nokugcina amadokhumenti obuchwepheshe. Imitholampilo kumele futhi iqoke Umuntu Onomthwalo Wokuthobela Umthetho (i-PRRC) ukuze aqaphe ukunamathela kulezi zindinganiso.
Ngokwezimiso zokuziphatha, imitholampilo kumele ibeke phambili ukuphepha nobumfihlo besiguli. Ukugcina ubumfihlo besiguli, ikakhulukazi ngamarekhodi ezempilo kagesi, kubalulekile. Imitholampilo kumele futhi ithole imvume enolwazi yazo zonke izindlela zokwelapha, kusetshenziswa ulimi olucacile noluqondakalayo. Ngokukhuthaza isiko lobuqotho nokungafihli lutho, imitholampilo ingakha ukwethembana neziguli zayo futhi ifake isandla ekuthuthukisweni kokunakekelwa kwamazinyo.
Ukuqinisekisa Ukuthobela Imithetho Emtholampilo Wakho Wamazinyo
Izinyathelo Zokuqinisekisa Isitifiketi se-CE Semikhiqizo
UkuqinisekisaIsitifiketi se-CEUkuhlolwa kwemikhiqizo ye-orthodontic kubalulekile ekuqinisekiseni ukuhambisana nezindinganiso ze-EU MDR. Imitholampilo yamazinyo kufanele iqale ngokuhlola ukulebula komkhiqizo. Uphawu lwe-CE kumele lubonakale kahle, kanye nenombolo yokuhlonza yomzimba owazisiwe ohlole umkhiqizo. Imitholampilo kufanele futhi icele iSimemezelo Sokuhambisana nomenzi. Lo mbhalo uqinisekisa ukuthi umkhiqizo uhlangabezana nazo zonke izidingo zomthetho ezifanele.
Ukubukeza amadokhumenti obuchwepheshe kuyisinyathelo esibalulekile. Umkhiqizo ngamunye kufanele ube nombiko wokuhlolwa kwezokwelapha (i-CER) kanye nobufakazi obusekelayo bokuphepha nokusebenza. Imitholampilo ingabuye ibheke isizindalwazi se-EUDAMED ukuqinisekisa ukubhaliswa komkhiqizo kanye nesimo sokuthobela imithetho. Ukuvuselela njalo lokhu kuhlola kuqinisekisa ukuthi yonke imikhiqizo yamazinyo esetshenziswa emtholampilo ihlala ihambisana nemithetho yamanje.
Ukukhetha Abaphakeli Abanedumela Elihle Bemikhiqizo Ye-Orthodontic
Ukukhetha abahlinzeki abathembekile kubalulekile ekugcineni amazinga aphezulu ekunakekelweni kwamazinyo. Imitholampilo kufanele ibeke phambili abahlinzeki abathobela imithetho yemboni, njengokuthiUkumaka kwe-CE ekuvunyelweni kwe-EU noma i-FDA e-USIzinhlangano zokuhlola ezivela eceleni zidlala indima ebalulekile ekuqinisekiseni ikhwalithi kanye nokuhambisana kwemikhiqizo. Imitholampilo kufanele ibuze ngalezi zitifiketi ngesikhathi senqubo yokukhetha umhlinzeki.
Izinkomba zokusebenza ezibalulekile (ama-KPI) zingasiza ekuhloleni ukuthembeka komhlinzeki. Amamethrikhi afana nokukhiqiza, isikhathi somjikelezo wokukhiqiza, kanye nesikhathi sokushintsha kunikeza ukuqonda ngokusebenza kahle kokukhiqiza kanye nokuguquguquka. Ukubeka amazinga ekhwalithi acacile, njengesilinganiso sokukhubazeka se-Six Sigma noma i-Acceptable Quality Level (AQL), kuqinisekisa ikhwalithi yomkhiqizo ehambisanayo. Ukubambisana nabahlinzeki abahlangabezana nalezi zindinganiso kunciphisa izingozi zokuthobela imithetho futhi kuthuthukisa ukuphepha kwesiguli.
Abasebenzi Abaqeqeshwayo Ngezidingo Zokuthobela Imithetho ye-EU MDR
Ukuqeqesha abasebenzi mayelana nokuthobela imithetho ye-EU MDR kuyindlela esebenzayo yokuqinisekisa ukulandelwa kwemithetho. Imitholampilo kufanele ihlele ama-workshops kanye nezikhathi zokuqeqesha ukuze kufundiswe abasebenzi mayelana nezibuyekezo zakamuva ze-MDR. Izihloko kufanele zifake ukubaluleka kwesitifiketi se-CE, indima ye-Unique Device Identifiers (UDI), kanye nezidingo zokugcina amadokhumenti obuchwepheshe.
Izikhathi zokuqeqesha ezisebenzayo zingathuthukisa nokuqonda kwabasebenzi ngezinqubo zokuthobela imithetho. Isibonelo, abasebenzi bangafunda ukuthi bangaqinisekisa kanjani isitifiketi se-CE, baphathe ukulandelelwa kokubulala inzalo, futhi basebenzise izinhlelo zokulawula izingozi. Ukuqeqeshwa okuvamile akugcini nje ngokuthuthukisa ikhono labasebenzi kodwa futhi kukhuthaza isiko lokuthobela imithetho emtholampilo.
Ukwenza Ukuhlolwa Kokuthobela Imithetho Okuvamile kanye Nokubhala Amadokhumenti
Ukuhlolwa kokuhambisana nomthetho njalo kudlala indima ebalulekile ekuqinisekiseni ukuthi imitholampilo yamazinyo ilandela amazinga e-EU MDR. Lokhu kuhlolwa kusiza ekuboneni izikhala ezinqubweni, ukuqinisekisa izitifiketi zomkhiqizo, nokuqinisekisa ukuthi wonke amadivayisi e-orthodontic ahlangabezana nezidingo zomthetho. Imitholampilo eyenza ukuhlolwa okuvamile ingabhekana nezinkinga ezingaba khona ngaphambi kokuba zikhule zibe yizinkinga zomthetho noma zokuphepha.
Ukuze kwenziwe ukuhlolwa kokuthobela imithetho okuphumelelayo, imitholampilo kufanele ilandele indlela ehlelekile:
- Dala Uhlu Lokuhlola Lokuhlola: Faka izindawo ezibalulekile njengezitifiketi zomkhiqizo, amarekhodi okubulala inzalo, kanye nezingobo zokuqeqeshwa kwabasebenzi.
- Buyekeza Amadokhumenti ObuchwephesheQinisekisa ukuthi yonke imikhiqizo ye-orthodontic inemibiko yokuhlolwa kwezokwelapha (ama-CER) kanye nezimemezelo zokuvumelana.
- Hlola Uhlu LwempahlaQinisekisa ukuthi wonke amadivayisi anophawu lwe-CE futhi ahlangabezana nezidingo zokulandelela, njenge-Unique Device Identifier (UDI).
- Hlola Izinqubo: Hlola izinqubo zokubulala inzalo, izinhlelo zokuphatha ubungozi, kanye nemisebenzi yokuqapha ngemuva kwemakethe.
Ithiphu: Nika isikhulu esizinikele ekulandeleni imithetho ukuqondisa inqubo yokuhlola. Lokhu kuqinisekisa ukuzibophezela kanye nokungaguquguquki ekulondolozeni amazinga okulawula.
Imibhalo ibaluleke ngokulinganayo ekuboniseni ukuthobela imithetho. Imitholampilo kumele igcine amarekhodi anemininingwane okuhlolwa, okuhlanganisa okutholakele, izinyathelo zokulungisa, kanye nezinyathelo zokulandelela. La marekhodi asebenza njengobufakazi ngesikhathi sokuhlolwa yiziphathimandla ezilawulayo. Futhi asiza imitholampilo ukulandelela intuthuko yayo ekuhlangabezaneni nezidingo ze-EU MDR.
Uhlelo lokuthobela imithetho olubhalwe kahle alugcini nje ngokuqinisekisa ukunamathela emthethweni kodwa futhi lwakha ukwethembana neziguli. Imitholampilo ebeka phambili ukucaca kanye nokuzibophezela ikhuthaza idumela lokunakekelwa kwekhwalithi. Ngokuhlanganisa ukuhlolwa okuvamile kanye nemibhalo ephelele ekusebenzeni kwayo, imitholampilo yamazinyo ingabhekana ngokuzethemba nobunzima bokuthobela imithetho ye-EU MDR.
Imikhiqizo ye-Orthodontic Eqinisekiswe yi-CE idlala indima ebalulekile ekuqinisekiseni ukuphepha kwesiguli kanye nokugcina ukuthobela imithetho. Le mikhiqizo ihlangabezana nezindinganiso eziqinile ze-EU MDR, ezigcina ikhwalithi kanye nokuthembeka kokunakekelwa kwamazinyo. Ngokulandela le mithetho, imitholampilo yamazinyo ingavikela iziguli zayo futhi ikhuthaze ukwethenjwa kwezinsizakalo zayo. Ukubeka phambili ukuthobela imithetho akugcini nje ngokugcwalisa izibopho zomthetho kodwa futhi kubonisa ukuzibophezela ekwenzeni kahle kobungcweti. Imitholampilo eyamukela le mikhuba inikela ekwelashweni kwe-orthodontic okuphephile, okusebenzayo futhi ibeka uphawu lwekhwalithi embonini.
Imibuzo Evame Ukubuzwa
Lisho ukuthini uphawu lwe-CE emikhiqizweni ye-orthodontic?
IUphawu lwe-CEikhombisa ukuthi umkhiqizo uhambisana nezindinganiso zokuphepha, impilo, kanye nezemvelo ze-EU. Iqinisekisa imitholampilo yamazinyo kanye neziguli ukuthi umkhiqizo uhlangabezana nezimfuneko zomthetho eziqinile futhi usebenza njengoba kuhlosiwe.
Ithiphu: Qinisekisa njalo uphawu lwe-CE kanye nemibhalo ehambisana nalo ngaphambi kokuthenga imikhiqizo ye-orthodontic.
Imitholampilo yamazinyo ingaqinisekisa kanjani ukuthi iyahambisana ne-EU MDR?
Imitholampilo yamazinyo ingaqinisekisa ukuthobela imithetho ngokuqinisekisa isitifiketi se-CE, ukugcina amadokhumenti afanele, nokwenza ukuhlolwa okuvamile. Ukuqeqesha abasebenzi ngezidingo ze-EU MDR nokukhetha abahlinzeki abathembekile nakho kudlala indima ebalulekile ekuhlangabezaneni nezindinganiso zomthetho.
Ingabe imikhiqizo eqinisekiswe yi-CE iyimpoqo emitholampilo yamazinyo e-EU?
Yebo, imikhiqizo eqinisekiswe yi-CE iyimpoqo emitholampilo yamazinyo e-EU. Le mikhiqizo ihlangabezana nezindinganiso zokuphepha eziqinile kanye nokusebenza ezichazwe ku-EU MDR, okuqinisekisa ukuphepha kweziguli kanye nokuthobela imithetho.
Iyini i-Unique Device Identifier (UDI), futhi kungani ibalulekile?
I-UDI iyikhodi eyingqayizivele enikezwe amadivayisi ezokwelapha ukuze kulandelelwe. Isiza imitholampilo ukulandelela imikhiqizo kuyo yonke impilo yayo, iqinisekisa ukuphathwa kahle kwempahla kanye nokuphepha kweziguli.
Inothi: Uhlelo lwe-UDI luyimfuneko ebalulekile ngaphansi kwe-EU MDR.
Imitholampilo yamazinyo kufanele yenze kangaki ukuhlolwa kokuthobela imithetho?
Imitholampilo yamazinyo kufanele yenze ukuhlolwa kokuthobela imithetho okungenani njalo ngonyaka. Ukuhlolwa okuvamile kusiza ekuboneni izikhala, ukuqinisekisa izitifiketi zomkhiqizo, nokuqinisekisa ukunamathela ezindinganisweni ze-EU MDR. Ukubuyekezwa okuvamile kunciphisa izingozi futhi kugcine ukunakekelwa kwekhwalithi ephezulu.
Isikhumbuzi se-Emoji:
Isikhathi sokuthunyelwe: Mashi-29-2025