Iimveliso ze-orthodontic eziqinisekiswe yi-CE zidlala indima ebalulekileyo kunyango lwamazinyo lwanamhlanje ngokuqinisekisa ukhuseleko kunye nomgangatho. Ezi mveliso zihlangabezana nemigangatho engqongqo ye-European Union, ziqinisekisa ukuthembeka kwazo kwizigulane kunye noogqirha. UMthetho weZixhobo zonyango we-EU (MDR) uzise iimfuno ezingqongqo zokuphucula ukhuseleko lwezigulane. Umzekelo:
- Izixhobo zamazinyo kufuneka ngoku zibeilandelelwe kwinkqubo yabo yokubulala iintsholongwane.
- Oogqirha bamazinyo abasebenzisa iteknoloji ye-CAD/CAM bajongene neembopheleleko ezongezelelweyo zokuthobela imithetho, kuquka neenkqubo zolawulo lomngcipheko.
Ukuthobela le migangatho kukhusela izigulana kwaye kuqinisekisa ukuba iikliniki zamazinyo ziyahlangabezana neembopheleleko zomthetho, nto leyo ekhuthaza ukuthembana kunye nobungcali kweli candelo.
Izinto ezibalulekileyo ekufuneka ziqwalaselwe
- Isatifikethi se-CE sibonisa ukuba iimveliso ze-orthodontic zikhuselekile kwaye zisemgangathweni ophezulu.
- Iikliniki zamazinyo mazijonge iilebhile kwaye zicele amaxwebhu okuqinisekisa isiqinisekiso se-CE.
- Ukuhlolwa rhoqo kunceda iikliniki zifumane iingxaki kwaye zilandele imithetho ye-EU MDR ukugcina izigulana zikhuselekile.
- Ukuthenga kubathengisi abathembekileyo kunciphisa iingozi kwaye kuphucula ukhathalelo lwezigulane.
- Ukufundisa abasebenzi ngemithetho ye-EU MDR kunceda wonke umntu azi indlela yokugcina izinto zikhuselekile kwaye zisemgangathweni ophezulu.
Zithini iimveliso ze-Orthodontic eziqinisekiswe yi-CE?
Inkcazo kunye nenjongo yeSiqinisekiso se-CE
Isatifikethi se-CE luphawu lomgangatho nokhuseleko oluqatshelwayo kulo lonke iManyano yaseYurophu. Sithetha ukuba imveliso iyahambelana nemigaqo ye-EU, iqinisekisa ukuba iyahlangabezana nemigangatho yempilo, ukhuseleko, kunye nokukhuselwa kwendalo. Kwiimveliso ze-orthodontic, esi siqinisekiso siqinisekisa ukuba zikhuselekile kwizigulana kwaye ziyasebenza ekusetyenzisweni kwazo. Iikliniki zamazinyo zixhomekeke kwiimveliso ze-orthodontic eziqinisekiswe yi-CE ukugcina imigangatho ephezulu yokhathalelo kunye nokwakha ukuthembana kwizigulana zazo.
Injongo yesatifikethi se-CE idlulela ngaphaya kokuthobela imithetho. Ikwakhuthaza ukuhambelana komgangatho wemveliso kwimarike ye-EU. Oku kuqinisekisa ukuba iimveliso ze-orthodontic, ezinje ngeebrakethi kunye neengcingo, zisebenza ngokuthembekileyo nokuba zenziwa okanye zisetyenziswa phi.
Inkqubo yeSatifikethi se-CE seeMveliso ze-Orthodontic
Inkqubo yokuqinisekiswa kwe-CE kwiimveliso ze-orthodontic ibandakanya amanyathelo aliqela abalulekileyo. Abavelisi kufuneka kuqalaukuqonda iimfuno ezithile zemarike, kuquka nesidingo sokumakishwa kwe-CE kwi-EU. Emva koko kufuneka baqinisekise ukuba iimveliso zabo ziyahlangabezana nemigangatho ebalulekileyo yokhuseleko kunye nokusebenza echazwe kwi-EU Medical Device Regulation (MDR). Ukusebenzisana neearhente zovavanyo ezivunyiweyo zamaqela esithathu kubalulekile ukuze kuvavanywe ngokungqongqo ukuthobela imveliso kunye nomgangatho wayo.
Ukuhlala unolwazi ngotshintsho olulawulayo yenye into ebalulekileyo kule nkqubo. Iimpapasho zoshishino kunye neengcali zomthetho zibonelela ngengqiqo ebalulekileyo malunga namaxesha okuthobela imithetho kunye nemigangatho eguqukayo. Nje ukuba imveliso iphumelele zonke iimvavanyo, ifumana uphawu lwe-CE, olubonisa ukulungela kwayo imakethi ye-EU.
Imizekelo yeeMveliso ze-Orthodontic eziQinisekisiweyo yi-CE
Iimveliso ze-orthodontic eziqinisekiswe yi-CE ziquka uluhlu olubanzi lwezixhobo kunye nezixhobo ezisetyenziswa kwiikliniki zamazinyo. Imizekelo ibandakanya iibrakethi ze-orthodontic, ii-archwires, kunye nee-aligners. Ezi mveliso zivavanyelwa nzima ukuqinisekisa ukuba ziyahlangabezana nemigangatho ephezulu yokhuseleko kunye nokusebenza. Umzekelo, iibrakethi ze-orthodontic eziveliswa ziinkampani ezifana neDenrotary Medical zenziwa kusetyenziswa izixhobo eziphambili kwaye zilandela amanyathelo angqongqo okulawula umgangatho. Oku kuqinisekisa ukuba iingcali zamazinyo zinokuthembela kwezi mveliso ukuze zinike unyango olusebenzayo nolukhuselekileyo kwizigulana zazo.
Ukuqonda iMigangatho ye-EU MDR
Iimfuno eziphambili ze-EU MDR kwiimveliso ze-Orthodontic
UMthetho weZixhobo zonyango ze-EU (MDR), owaziwa ngokusemthethweni njengoI-EU 2017/745, iseka isakhelo esibanzi sokulawula izixhobo zonyango, kuquka iimveliso zamazinyo. Lo mthetho waba yimfuneko kuwo onke amazwe e-EU ngoMeyi 2021. Ujolise ekuphuculeni ukhuseleko, ukuxhasa ukuveliswa kwezinto ezintsha, kunye nokuqinisekisa umgangatho ohambelanayo.
Iimfuno eziphambili ziquka:
- Akukho Mthetho Wokuba NgutatomkhuluIzixhobo ezivunyiweyo phantsi koMyalelo weZixhobo zezoNyango (MDD) wangaphambili kufuneka zenze uvavanyo olutsha lokuhambelana nemigangatho ye-MDR.
- Isazisi seSixhobo esiKhethekileyo (i-UDI)Zonke iimveliso ze-orthodontic kufuneka zibe ne-UDI ukuze kuphuculwe ukulandeleka.
- Ulawulo lokubulala iintsholongwaneIzixhobo zamazinyo mazibonise ukuba ziyalandeleka na kwiinkqubo zazo zokubulala iintsholongwane.
Ezi mfuneko ziqinisekisa ukuba iimveliso ze-orthodontic ziyahlangabezana nemigangatho yokhuseleko engqongqo kunye nokusebenza, zikhusela izigulana kunye noogqirha ngokufanayo.
Indlela i-EU MDR eqinisekisa ngayo ukhuseleko kunye nokusebenza
I-EU MDR iphucula ukhuseleko kunye nokusebenza ngokusebenzisa amanyathelo olawulo aqinileyo. Abavelisi kufuneka banike ubungqina bezonyango ukubonisa ukhuseleko kunye nokusebenza kakuhle kweemveliso zabo. Oku kuquka ukubhala phantsi umjikelo wobomi bonke besixhobo.
Lo mgaqo ukwayalela ukubaInkqubo yoLawulo loMgangatho (i-QMS)kunye nenkqubo yoGcino-zimvo emva kweMarike (PMS). Ezi nkqubo zijonga ukusebenza kwemveliso kwaye zijongana neengozi ezinokubakho. Umzekelo, iimveliso ze-orthodontic kufuneka zithobele imigangatho ye-ISO 14971:2019 yolawulo lomngcipheko. Ngokufuna la manyathelo, i-EU MDR inciphisa amathuba okuba kubekho iziganeko ezimbi, ezifana nezo zibonwe kwiingxelo zezixhobo zonyango zangaphambili.
Uhlaziyo lwakutshanje kwiiKlinikhi zamazinyo ze-EU MDR ezichaphazela i-EU
Uhlaziyo oluninzi kwi-EU MDR luchaphazela ngqo iikliniki zamazinyo. Utshintsho oluvela kwi-MDD ukuya kwi-MDR, oluqale ukusebenza ngoMeyi 2021, lufuna ukuba zonke izixhobo ezivunyiweyo ngaphambili ziphinde zivavanywe ngoMeyi 2024. Oku kuqinisekisa ukuthotyelwa kwemigangatho yamva nje.
Ukuqaliswa kwenkqubo ye-UDI kuphucula ukulandeleka kwemveliso, ngakumbi kwizixhobo ezifakelwayo zeKlasi III. Ukongeza, oogqirha bamazinyo abasebenzisa ubuchwepheshe be-CAD/CAM ngoku bahlelwa njengabavelisi. Kufuneka basebenzise iinkqubo zolawulo lomgangatho kwaye bathobele iimbopheleleko ze-MDR.
Isiseko sedatha se-EUDAMED simele olunye uhlaziyo olubalulekileyo. Eli qonga liqokelela kwaye licubungula ulwazi malunga nezixhobo zonyango, liphucula ukucaca kunye nokuhamba kolwazi. Olu tshintsho lugxininisa ukubaluleka kokuthobela imithetho kwiikliniki zamazinyo ezisebenzisa iiMveliso ze-Orthodontic eziQinisekisiweyo yi-CE.
Kutheni Ukuthobela Imithetho Kubalulekile KwiiKlinikhi Zamazinyo
Iingozi zokungathobeli i-EU MDR
Ukungathobeli imigangatho ye-EU MDR kubeka emngciphekweni omkhulu kwiikliniki zamazinyo. Ukwaphulwa kwemithetho kungakhokelela kwimiphumo emibi yezomthetho, kubandakanya izohlwayo, isohlwayo, okanye nokumiswa kwemisebenzi. Iikliniki zinokujongana nomonakalo wegama, okunokuphelisa ukuthembana kwesigulana kwaye kuchaphazele impumelelo yexesha elide. Ukongeza, ukusebenzisa iimveliso ze-orthodontic ezingathobeliyo kwandisa amathuba eziganeko ezimbi, ezinje ngokusilela kwezixhobo okanye ukwenzakala kwesigulana, okunokubangela ukuba kuhlawuliswe imali eninzi.
Ukungaphumeleli ukuhlangabezana neemfuno ze-EU MDR nako kunokuphazamisa ukusebenza kweklinikhi. Umzekelo, ukungabikho kwe-Unique Device Identifier (UDI) kwiimveliso ze-orthodontic kunokuthintela ukulandeleka, kwenze kube nzima ukulawula impahla kunye nokunyamekela izigulane. Iikliniki ezingayisebenzisiyo inkqubo yoLawulo loMgangatho (QMS) okanye inkqubo yoHlolo lweMarike (PMS) zinokuba nzima ukujongana neenkxalabo zokhuseleko ngokufanelekileyo, nto leyo ebangela ukuba zijongwe ngokufanelekileyo ngumthetho.
Iingenelo zokusebenzisa iimveliso ze-Orthodontic eziqinisekiswe yi-CE
Ukusebenzisa iiMveliso ze-Orthodontic eziQinisekisiweyo yi-CE kunika iingenelo ezininzi kwiikliniki zamazinyo. Ezi mveliso zihlangabezana nemigangatho yokhuseleko engqongqo kunye nokusebenza, ziqinisekisa unyango oluthembekileyo nolusebenzayo. Izigulana ziyazuza kwiziphumo eziphuculweyo, ngelixa iikliniki zifumana udumo lonyango olusemgangathweni. Isiqinisekiso se-CE sikwenza kube lula ukuthobela iimfuno ze-EU MDR, sinciphise umthwalo wolawulo kwiikliniki.
Iiklinikhi ezibeka phambili iimveliso eziqinisekisiweyo ze-CE zinokwenza kube lula ukusebenza kwazo. Umzekelo, ukulandeleka kwezi mveliso kuphucula ulawulo lwezinto ezisetyenzisiweyo kwaye kuxhasa ulawulo lokubulala iintsholongwane. Oku kuqinisekisa ukuba zonke izixhobo ziyahlangabezana nemigangatho yococeko, kunciphisa umngcipheko wosulelo. Ukongeza, iimveliso eziqinisekisiweyo ze-CE zihlala ziza namaxwebhu apheleleyo, okwenza kube lula kwiiklinikhi ukugcina ukuthotyelwa kwemithetho.
Uxanduva lwezomthetho nolwemigaqo yokuziphatha lweeKlinikhi zamazinyo
Iikliniki zamazinyo zinembopheleleko zomthetho nezokuziphatha zokuthobela imigangatho ye-EU MDR. Ngokomthetho, iikliniki kufuneka ziqinisekise ukuba zonke izixhobo zonyango, kuquka iimveliso ze-orthodontic, ziyahlangabezana neemfuno zomthetho. Oku kuquka:ukuphumeza ulawulo lwangaphakathi, ukuqhuba uphicotho-zincwadi rhoqo, nokugcina amaxwebhu obuchwephesha. Iiklinikhi kufuneka zikwakhethe uMntu onoxanduva lokuThotyelwa kweMithetho yoLawulo (i-PRRC) ukuba ajonge ukuthotyelwa kwale migangatho.
Ngokwemigaqo yokuziphatha, iikliniki kufuneka zibeke phambili ukhuseleko kunye nokugcinwa kwemfihlo kwesigulana. Ukugcina ubumfihlo besigulana, ingakumbi ngeerekhodi zempilo ze-elektroniki, kubalulekile. Iikliniki kufuneka zifumane imvume enolwazi lwazo zonke iindlela zonyango, zisebenzisa ulwimi olucacileyo noluqondakalayo. Ngokukhuthaza inkcubeko yokuthembeka kunye nokungafihlisi, iikliniki zinokukha ukuthembana nezigulana zazo kwaye zinegalelo ekuphuculeni ngokubanzi ukhathalelo lwamazinyo.
Ukuqinisekisa Ukuthobela Imithetho KwiKliniki Yakho Yamazinyo
Amanyathelo okuqinisekisa isiqinisekiso se-CE seemveliso
UkuqinisekisaIsatifikethi se-CEiimveliso zamazinyo zibalulekile ukuqinisekisa ukuthotyelwa kwemigangatho ye-EU MDR. Iikliniki zamazinyo maziqale ngokujonga ilebheli yemveliso. Uphawu lwe-CE kufuneka lubonakale ngokucacileyo, kunye nenombolo yokuchonga yomzimba ochaziweyo ovavanye imveliso. Iikliniki kufuneka zicele neSibhengezo sokuVumelana kumenzi. Olu xwebhu luqinisekisa ukuba imveliso iyahlangabezana nazo zonke iimfuno zomthetho ezifanelekileyo.
Ukuphonononga amaxwebhu obuchwephesha lelinye inyathelo elibalulekileyo. Imveliso nganye kufuneka ibe neNgxelo yoVavanyo lweKlinikhi (i-CER) kunye nobungqina obuxhasayo bokhuseleko kunye nokusebenza. Iiklinikhi zinokujongana nedathabheyisi ye-EUDAMED ukuqinisekisa ukubhaliswa kwemveliso kunye nesimo sokuthobela imithetho. Ukuhlaziya rhoqo olu vavanyo kuqinisekisa ukuba zonke iimveliso zamazinyo ezisetyenziswa ekliniki zihlala zihambelana nemigaqo yangoku.
Ukukhetha Ababoneleli Abahloniphekileyo Beemveliso Ze-Orthodontic
Ukukhetha ababoneleli abathembekileyo kubalulekile ekugcineni imigangatho ephezulu kunyango lwamazinyo. Iiklinikhi kufuneka zibeke phambili ababoneleli abathobela imigaqo yoshishino, efanaUkumakishwa kwe-CE kwimvume ye-EU okanye ye-FDA e-USIiarhente zovavanyo zamaqela esithathu zidlala indima ebalulekileyo ekuqinisekiseni umgangatho kunye nokuthobela kwemveliso. Iiklinikhi kufuneka zibuze ngezi ziqinisekiso ngexesha lenkqubo yokukhetha umthengisi.
Izalathisi zokusebenza eziphambili (ii-KPI) zinokunceda ekuvavanyeni ukuthembeka komthengisi. Imilinganiselo efana nemveliso, ixesha lomjikelo wokuvelisa, kunye nexesha lokutshintsha inika ulwazi ngokusebenza kakuhle kwemveliso kunye nokuguquguquka kwayo. Ukubeka imigangatho ecacileyo yomgangatho, njengezinga leziphene zeSix Sigma okanye iNqanaba loMgangatho oVumelekileyo (i-AQL), kuqinisekisa umgangatho wemveliso ohambelanayo. Ukusebenzisana nababoneleli abahlangabezana nale migangatho kunciphisa umngcipheko wokuthobela imithetho kwaye kuphucula ukhuseleko lwezigulane.
Abasebenzi boQeqesho kwiiMfuno zokuThotyelwa kweMithetho ye-EU MDR
Uqeqesho lwabasebenzi malunga nokuthobela i-EU MDR yindlela esebenzayo yokuqinisekisa ukuthotyelwa kwemigaqo. Iiklinikhi kufuneka zilungiselele iiworkshops kunye neeseshoni zoqeqesho ukufundisa abasebenzi malunga nohlaziyo lwamva nje lwe-MDR. Izihloko kufuneka zibandakanye ukubaluleka kwesatifikethi se-CE, indima ye-Unique Device Identifiers (UDI), kunye neemfuno zokugcina amaxwebhu obuchwephesha.
Iiseshoni zoqeqesho ezisebenzayo zinokuphucula ukuqonda kwabasebenzi ngeenkqubo zokuthobela imithetho. Umzekelo, abasebenzi banokufunda indlela yokuqinisekisa isiqinisekiso se-CE, ukulawula ukulandeleka kokubulala iintsholongwane, kunye nokusebenzisa iinkqubo zolawulo lomngcipheko. Uqeqesho oluqhelekileyo alugcini nje ngokuphucula ubuchule babasebenzi kodwa lukwakhuthaza nenkcubeko yokuthobela imithetho kwiklinikhi.
Ukwenza uPhicotho oluQhelekileyo lokuthobela imithetho kunye noXwebhu
Ukuhlolwa rhoqo kokuthobela imithetho kudlala indima ebalulekileyo ekuqinisekiseni ukuba iikliniki zamazinyo ziyahambelana nemigangatho ye-EU MDR. Olu kuhlolwa lunceda ekuchongeni izikhewu kwiinkqubo, ukuqinisekisa iziqinisekiso zemveliso, nokuqinisekisa ukuba zonke izixhobo zamazinyo ziyahlangabezana neemfuno zomthetho. Iikliniki ezenza uhlolo oluqhelekileyo zinokujongana nemiba enokubakho ngaphambi kokuba ikhule ibe yinkxalabo yezomthetho okanye yokhuseleko.
Ukuze kwenziwe uphicotho olusebenzayo lokuthobela imithetho, iikliniki kufuneka zilandele indlela ecwangcisiweyo:
- Yenza Uluhlu Lokuhlola Uhlolo: Bandakanya iindawo ezibalulekileyo ezifana neziqinisekiso zemveliso, iirekhodi zokubulala iintsholongwane, kunye neengxelo zoqeqesho lwabasebenzi.
- Uhlolo lweeMxwebhu zoBugcisa: Qinisekisa ukuba zonke iimveliso ze-orthodontic zineeNgxelo zoVavanyo lweKliniki (ii-CER) ezihlaziyiweyo kunye neeSibhengezo zokuThotyelwa kweMithetho.
- Hlola uluhlu lwezinto ezikhoyoQinisekisa ukuba zonke izixhobo zinophawu lwe-CE kwaye ziyahlangabezana neemfuno zokulandeleka, njenge-Unique Device Identifier (UDI).
- Vavanya iiNkqubo: Ukuvavanya iinkqubo zokubulala iintsholongwane, iinkqubo zolawulo lomngcipheko, kunye nemisebenzi yokujonga emva kwemarike.
Ingcebiso: Nika igosa elizinikeleyo lokuthobela imithetho ukuba lijonge inkqubo yophicotho-zincwadi. Oku kuqinisekisa uxanduva kunye nokuhambelana kokugcina imigangatho yolawulo.
Uxwebhu lubaluleke ngokulinganayo ekuboniseni ukuthobela imithetho. Iikliniki kufuneka zigcine iirekhodi ezineenkcukacha zophicotho-zincwadi, kuquka iziphumo, amanyathelo okulungisa, kunye namanyathelo okulandela. Ezi rekhodi zisebenza njengobungqina ngexesha lokuhlolwa ziigunya zolawulo. Zikwanceda iikliniki ukuba zilandelele inkqubela yazo ekuhlangabezaneni neemfuno ze-EU MDR.
Inkqubo yokuthobela imithetho ebhalwe kakuhle ayiqinisekisi nje kuphela ukuthotyelwa komthetho kodwa ikwakha ukuthembana nezigulane. Iikliniki ezibeka phambili ukungafihlisi kunye noxanduva zikhuthaza udumo lokhathalelo olusemgangathweni. Ngokudibanisa uphicotho-zincwadi oluqhelekileyo kunye namaxwebhu apheleleyo kwimisebenzi yazo, iikliniki zamazinyo zinokuhamba ngokuzithemba kwiingxaki zokuthobela i-EU MDR.
Iimveliso ze-Orthodontic eziQinisekisiweyo yi-CE zidlala indima ebalulekileyo ekuqinisekiseni ukhuseleko lwezigulane kunye nokugcina ukuthotyelwa kwemithetho. Ezi mveliso zihlangabezana nemigangatho engqongqo ye-EU MDR, egcina umgangatho kunye nokuthembeka kokhathalelo lwamazinyo. Ngokulandela le migaqo, iikliniki zamazinyo zinokukhusela izigulana zazo kwaye zikhuthaze ukuthembana kwiinkonzo zazo. Ukubeka phambili ukuthotyelwa kwemithetho akupheleli nje ekuzalisekiseni iimbopheleleko zomthetho kodwa kubonisa nokuzibophelela ekugqweseni kobungcali. Iikliniki ezamkela ezi ndlela zenza igalelo kunyango olukhuselekileyo nolusebenzayo ngakumbi lwe-orthodontic kwaye zibeka umlinganiselo womgangatho kushishino.
FAQ
Ithetha ukuthini uphawu lwe-CE kwiimveliso ze-orthodontic?
IUphawu lwe-CEibonisa ukuba imveliso ihambelana nemigangatho yokhuseleko, impilo, kunye nokusingqongileyo ye-EU. Iqinisekisa iikliniki zamazinyo kunye nezigulana ukuba imveliso ihlangabezana neemfuno ezingqongqo zomthetho kwaye isebenza njengoko bekucetyiwe.
Ingcebiso: Soloko uqinisekisa uphawu lwe-CE kunye namaxwebhu ahamba nayo phambi kokuba uthenge iimveliso ze-orthodontic.
Iikliniki zamazinyo zingaqinisekisa njani ukuba ziyathotyelwa i-EU MDR?
Iiklinikhi zamazinyo zinokuqinisekisa ukuthotyelwa kwemithetho ngokuqinisekisa isiqinisekiso se-CE, ukugcina amaxwebhu afanelekileyo, kunye nokwenza uhlolo rhoqo. Uqeqesho lwabasebenzi kwiimfuno ze-EU MDR kunye nokukhetha ababoneleli abathembekileyo nako kudlala indima ebalulekileyo ekuhlangabezaneni nemigangatho yolawulo.
Ngaba iimveliso eziqinisekiswe yi-CE ziyimfuneko kwiikliniki zamazinyo e-EU?
Ewe, iimveliso eziqinisekisiweyo yi-CE ziyimfuneko kwiikliniki zamazinyo kwi-EU. Ezi mveliso zihlangabezana nemigangatho yokhuseleko kunye nokusebenza echazwe kwi-EU MDR, ukuqinisekisa ukhuseleko lwezigulane kunye nokuthotyelwa komthetho.
Yintoni i-Unique Device Identifier (UDI), kwaye kutheni ibalulekile?
I-UDI yikhowudi eyahlukileyo enikwe izixhobo zonyango ukuze zilandelelwe. Inceda iiklinikhi ukuba zilandelele iimveliso kulo lonke ixesha lazo lobomi, iqinisekisa ulawulo olufanelekileyo lwezinto ezisetyenzisiweyo kunye nokhuseleko lwezigulane.
PhawulaInkqubo ye-UDI yimfuneko ephambili phantsi kwe-EU MDR.
Iiklinikhi zamazinyo kufuneka zenze kangaphi uhlolo lokuthobela imithetho?
Iiklinikhi zamazinyo kufuneka zenze uphicotho lokuthobela imithetho ubuncinane rhoqo ngonyaka. Uhlolo oluqhelekileyo lunceda ekuchongeni izikhewu, ukuqinisekisa iziqinisekiso zemveliso, nokuqinisekisa ukuthotyelwa kwemigangatho ye-EU MDR. Uhlolo oluqhubekayo lunciphisa iingozi kwaye lugcina ukhathalelo olusemgangathweni ophezulu.
Isikhumbuzo se-Emoji:
Ixesha leposi: Matshi-29-2025