Ngokuqiniswa okukhulayo kokulawulwa kwedivaysi yezokwelapha komhlaba, izinkampani zaphesheya kwezilwandle ezingena ezimakethe zaseYurophu nezeMelika zidinga ukuhlangabezana hhayi kuphela izidingo zokuvunyelwa kwamakethe zangaphambi kokumaketha, kepha futhi zibhekane nokuhlola okunzima kwezindiza (akukho ukuhlolwa kwesaziso) kanye nokubhekwa kwemakethe (PMS). Kunokwehluka okukhulu ekuziphatheni okulawulayo, izindlela zokuhlola nezinhlawulo phakathi kwe-US FDA ne-EU MDR / IVDR.
Yini i-FDA (I-US Food and Drug Administration) ?
I-FDA ilawula ukuphepha nokusebenza kahle kwamadivayisi wezokwelapha e-United States. Kwamadivayisi amaningi, abakhiqizi kumele balethe i-510 (k) ukufakazela ukuthi umkhiqizo wabo uphephile, uyasebenza futhi ulingana kakhulu nedivayisi evunyelwe evunyelwe.
Yini i-MDR (I-Medical Regulation) ?
i-MDR Ingabe umthetho we-European Union wamadivaysi ezokwelapha, ungene esikhundleni se-MDD yangaphambili (umqondiso wedivayisi yezokwelapha). Inezidingo eziqinile zokuhlolwa kwemitholampilo, ukubhekwa kwemakethe ngemuva kwemibhalo, kanye nemibhalo yezobuchwepheshe ukuqinisekisa ukuphepha okuphezulu kweziguli kanye nokusobala.
Ukuzulazula bobabili i-FDA ne-MDR kuyinkinginkimbi - kepha kubucayi. E-JoyTech, sakha uhlelo lokuthobela umhlaba wonke oluqinile ukusiza abalingani bethu bebhizinisi ukuba bahlangabezane nalezi zindinganiso ezifunwayo ngokuzethemba. Noma ngabe uyanda e-US noma ungena e-EU ngaphansi kwe-MDR, imikhiqizo yethu eqinisekisiwe, imibhalo yobuchwepheshe, kanye nobuchwepheshe bokulawula lapha ukuzokuxhasa.
W hat w e h h ave?
E-JoyTech, sisungule isisekelo esiqinile sokulawula ukunika amandla ozakwethu emhlabeni jikelele. UJoyTech wakhe uhlaka lokuhambisana oluphelele nolusethumpelayo oluhlangabezana nezidingo zomhlaba wonke ezimakethe ezinkulu zezokwelapha.
I-FDA 510 (K) imvume
UJoyTech usenesikhathi eside wasungula ubukhona obuqinile emakethe yase-US, nayo yonke imigqa yethu yomkhiqizo oyisisekelo esevele icushiwe futhi ihlinzekwe ngabalingani bomhlaba jikelele. Ukwakha kulesi sisekelo esiqinisekisiwe, ngokuqhubekayo sitshala imali emikhiqizweni esezingeni lomkhiqizo kanye nokuvuselelwa kokulawulwa ukuze sihlangabezane nokuvela kwezidingo zemitholampilo kanye nezidingo eziqondene nomlingani othile.
Ngo-2025, sandisa iphothifoliyo yethu ye-FDA enezitifiketi ezintsha eziningana:
I-Tubeless Upper ARM PRESTORE PRESTORE PRESTORTER - Ukunikeza ukuthuthukiswa okuthuthukisiwe kanye nesipiliyoni somsebenzisi.
Abaqaphi be-BP Abaqaphi be-BP abakhulu (DBP-6186 / 6286B) - yakhelwe amasayizi we-arm anwetshiwe (40-56 cm), ngezinketho ze-Bluetooth.
I-Compressor Nebulizers (NB-1100 kuya ku-NB-1103) - I-FDA-icoce ngaphansi komkhiqizo we-COCKOKISI, YENZA I-CORPRAPY Ethembekile Esezingeni eliphakeme ekhaya noma emitholampilo.
Isitifiketi se-EU MDR
UJoyTech uphakathi kwabakhiqizi bokuqala baseChina ukufeza isitifiketi se-EU MDR ngaphansi komthetho omusha. Ngo- Ephreli 2022 , sathola isitifiketi sethu sokuqala se-MDR kusuka ku-TÜV SÜD, ukumboza imikhiqizo efana nama-thermometers edijithali, ama-thermometers we-infrared (izindlebe (izindlebe ezingenakuhlasela umfutho wegazi . e-China izigaba eziningana nezithuthi zesifuba
Kusukela lapho, sesiqhubekile nokukhulisa iphothifoliyo yethu eqinisekisiwe ye-MDR. Ngo -Okthoba 2023 , bonke abaqaphi bengcindezi yegazi lesizukulwane esisha nama-thermometer bakwamukelwe imvume yeCE (MDR). Kusukela ngoFebhuwari 2025 , i-batch yethu yesine yemikhiqizo eqinisekisiwe ifaka:
Lokhu kunwetshwa okuqhubekayo kukhombisa ukuzibophezela okujulile kukaJoytech ekuthobeleni, ukusungulwa komkhiqizo, kanye nokuhleleka okuhle. Ukuqanjwa komkhiqizo okugcwele komkhiqizo wokuphila komkhiqizo, ukuvivinya, ukukhiqiza, amadokhumenti, kanye nokubhekwa kwamamakethe aseYurophu kakhulu, ukunika amandla abalingani bethu ngezixazululo eziqinisekisiwe, ezilungele ukuya ezimakethe kulo lonke elase-EU.
Ezinye Izindinganiso Zokulawula
Izinqubo zethu zokukhiqiza ziqinisekiswe ngaphansi kwe ISO 13485 neMdasa - , zihlangabezana nezidingo zokulawula ze-US, eCanada, Australia, Japan, naseBrazil.
Futhi, imikhiqizo ye-JoyTech nayo ivumelana ne-NMPPA (China), i-ROHS, futhi ifinyelele imiyalo, ukuphepha kokuphepha, ukuphepha kwezemvelo, kanye namazinga amadokhumenti kulo lonke elase-Asia ne-EU.
Kusho ukuthini kubalingani bethu？
Ukusebenza nge-JoyTech kusho okungaphezu kokudonsa umkhiqizo - kusho ukuthola umlingani onamasu aqonda ubunzima bokutholwa kwamanye amazwe.
v Izingozi eziphansi zokulawula nezindleko - Izitifiketi zethu ezilungele ukuya ku-GO kanye nesipiliyoni ngokuhlolwa kwamabhuku okuhlola komhlaba kunciphisa umthwalo kwinqubo yakho yokubhalisa yendawo.
v Ukufinyelela kwemakethe okusheshayo - ngamadivayisi aqinisekisiwe aqinisekisiwe, ungaqala ezifundeni zakho ezihlosiwe ngejubane elikhulu nokubambezeleka okumbalwa.
v ukwesekwa okwenziwe ngokwezifiso kwezobuchwepheshe nokwelashwa - kusuka emibhalweni yezobuchwepheshe kuya kwimininingwane yezokwelapha, iqembu lethu lokulawula endlini linikeza ukwesekwa okuhambisana nokuhlangabezana nezidingo zakho eziqondene nezwe.
v Ukulungela okufakazelwe kanye nokufundwa kwamabhuku - uhlelo lwethu lwekhwalithi ludlulise ukucwaningwa kwamabhuku okuphakathi kwamaqembu amaningi, futhi amadokhumenti ethu ahlala egcinwa e-Audit - aqinisekisa ukuthi sobala kanye nokusebenza kahle.
Isiphelo:
Njengoba imithethonqubo ivela, ngakho-ke thina. UJoyTech uzibophezele ukunwebeka ngokuqhubekayo ukunwebeka komgwaqo wawo wokuhambisana nomhlaba wonke onjenge- FDA ne -MDR - Ukubambisana nabalingani bethu banokuphazamiseka kwamadivayisi wezokwelapha aqinisekisiwe ezimakethe ezilawulwayo.
Sesivele sibambe izitifiketi ezifundeni ezinkulu zomhlaba wonke, kufaka phakathi iNyakatho Melika, i-EU, e-Asia, nangale kwalokho.
Ufuna ukwazi ukuthi siqinisekiswa emakethe yakho?
Ufuna isixazululo esilungele i-OEM / ODM solution?
Xhuma nethimba lethu namuhla ukuhlola imininingwane yesitifiketi somkhiqizo, imibhalo yezobuchwepheshe, kanye nezisombululo ezenziwe ngephrojekthi yakho. NgeJoyTech, ukuthobela kuba yinzuzo yakho yokuncintisana.
