Ngokuqiniswa okwandayo kokulawulwa kwemishini yezokwelapha emhlabeni wonke, izinkampani zaphesheya kwezilwandle ezingena ezimakethe zaseYurophu nezaseMelika azidingi nje ukuhlangabezana nezidingo eziyinkimbinkimbi zokugunyazwa ngaphambi kwemakethe, kodwa futhi zibhekane nokuhlolwa okuqinile kweFlying Inspection (No Notice Inspection) kanye Nokuhlola Kwangemva Kwemakethe (PMS). Kunomehluko omkhulu kungqondongqondo yokulawula, izindlela zokuhlola kanye nezinhlawulo phakathi kwe-US FDA ne-EU MDR/IVDR.
Iyini i-FDA (US Food and Drug Administration) ?
I-FDA ilawula ukuphepha nokusebenza kahle kwemishini yezokwelapha e-United States. Kumadivayisi amaningi, abakhiqizi kufanele bathumele i-510(k) ukuze baqinisekise ukuthi umkhiqizo wabo uphephile, uyasebenza, futhi ulingana kakhulu nedivayisi egunyaziwe ekhona.
Iyini i-MDR (Medical Device Regulation) ?
i-MDR isimiso se-European Union semishini yezokwelapha, esingena esikhundleni se-MDD yangaphambili (I-Medical Device Directive). Inezidingo eziqinile zokuhlolwa komtholampilo, ukubhekwa ngemuva kwemakethe, kanye nemibhalo yezobuchwepheshe ukuze kuqinisekiswe ukuphepha okuphezulu kwesiguli nokuba sobala.
Ukuzulazula kokubili i-FDA ne-MDR kuyinkimbinkimbi—kodwa kubalulekile. Kwa-Joytech, sakhe isistimu yokuthobelana yomhlaba wonke eqinile ukuze sisize ozakwethu bebhizinisi bahlangabezane nalezi zindinganiso ezidingekayo ngokuzethemba. Kungakhathaliseki ukuthi unwebela e-US noma ungena e-EU ngaphansi kwe-MDR, imikhiqizo yethu eqinisekisiwe, imibhalo yezobuchwepheshe, nobungcweti bokulawula kulapha ukuze kukusekele.
Senzenjani ?
Kwa-Joytech, sisungule isisekelo esiqinile sokulawula ukuze sinikeze amandla ozakwethu emhlabeni jikelele. I-Joytech yakhe uhlaka lokuthobela oluphelele nolubheke phambili oluhlangabezana nezidingo zokulawula emhlabeni wonke kuzo zonke izimakethe ezinkulu zezokwelapha.
I-FDA 510(k) Ukusula
I-Joytech kudala isungula ubukhona obuqinile emakethe yase-US, nayo yonke imigqa yethu yomkhiqizo ewumongo kakade i-FDA isisuliwe futhi ihlinzekwa ngenkuthalo kozakwethu bomhlaba. Sakhela phezu kwalesi sisekelo esiqinisekisiwe, siqhubeka nokutshala imali emisha yomkhiqizo nasekuvuseleleni kabusha umthetho ukuze sihlangabezane nezidingo zomtholampilo ezithuthukayo kanye nezidingo zephrojekthi eziqondene nozakwethu.
Ngo-2025, sanweba iphothifoliyo yethu ye-FDA ngezitifiketi ezintsha ezimbalwa:
Iziqapheli zomfutho wegazi ezingenayo i-tubeless - zinikeza ukuphatheka okuthuthukisiwe nolwazi lomsebenzisi.
Iziqapha ze-BP zezingalo ezinkulu zedijithali (DBP‑6186 / 6286B) — ziklanyelwe osayizi bengalo abanwetshiwe (40–56 cm), ngezinketho ze-Bluetooth.
Ama-Compressor nebulizers (NB‑1100 kuya ku-NB‑1103) — I-FDA-isulwe ngaphansi Kwekhodi Yomkhiqizo we-CAF, esekela ukwelashwa okuthembekile kokuphefumula ekhaya noma emitholampilo.
Isitifiketi se-EU MDR
IJoytech iphakathi kwabakhiqizi bokuqala baseShayina ukuthola isitifiketi se-EU MDR ngaphansi komthethonqubo omusha. Ngo- April 2022 , sathola isitifiketi sethu sokuqala se-MDR ku-TÜV SÜD, esihlanganisa imikhiqizo efana namathemometha edijithali, amathemometha e-infrared (indlebe nesiphongo), amaphampu wamabele, neziqapha zomfutho wegazi ezingahlaseli—okumaka ukugunyazwa kwe-MDR yokuqala e-China ezigabeni ezimbalwa ezihlanganisa amathemometha kagesi namaphampu amabele.
Kusukela lapho, siye saqhubeka nokwandisa iphothifoliyo yethu eqinisekiswe i-MDR minyaka yonke. Ngo -Okthoba 2023 , zonke iziqapheli zomfutho wegazi wesizukulwane esisha namathemometha asethole imvume ye-CE (MDR). Kusukela ngoFebhuwari 2025 , iqoqo lethu lesine lemikhiqizo eqinisekisiwe lihlanganisa:
Lokhu kwanda okuqhubekayo kukhombisa ukuzibophezela okujulile kwe-Joytech ekuthobeleni imithetho, ukusungula izinto ezintsha zomkhiqizo, kanye nokusebenza kahle kokulawula. Umjikelezo wethu wokuphila womkhiqizo ophelele—ukuklama, ukuhlola, ukukhiqiza, ukubhalwa kwemibhalo, nokugadwa kwangemva kwemakethe—kuhlangabezana nezindinganiso eziqinile zaseYurophu, kunikeza ozakwethu amandla ngezisombululo eziqinisekisiwe, ezilungele ukuthengiswa kuyo yonke i-EU.
Amanye Amazinga Okulawula
Izinqubo zethu zokukhiqiza zigunyazwa ngaphansi kwe -ISO 13485 kanye ne -MDSAP , ehlangabezana nezidingo zokulawula zase-US, Canada, Australia, Japan, naseBrazil.
Futhi, imikhiqizo ye-Joytech iphinde ihambisane neziqondiso ze-NMPA (China), RoHS, kanye ne-REACH, ukuphepha kokuhlangana, amazinga emvelo, kanye nemibhalo kulo lonke elase-Asia nase-EU.
Kusho ukuthini Kozakwethu？
Ukusebenza ne-Joytech kusho okungaphezu nje kokuthola umkhiqizo-kusho ukuthola uzakwethu onamasu oqonda ubunzima bokuthobela amazwe ngamazwe.
v Ubungozi obuphansi bokulawula kanye nezindleko - Izitifiketi zethu ezilungele ukuhamba kanye nolwazi lwethu ngokucwaningwa kwamabhuku komhlaba wonke kunciphisa umthwalo ohlelweni lwakho lokubhalisa endaweni.
v Ukufinyelela emakethe okusheshayo - Ngamadivayisi aqinisekiswe ngaphambilini, ungaqalisa ezindaweni oziqondise ngesivinini esikhulu kanye nokubambezeleka okumbalwa.
v Ukwesekwa okwenziwe ngokwezifiso kwezobuchwepheshe nokwelashwa - Kusukela kumadokhumenti ezobuchwepheshe kuye kudatha yomtholampilo, ithimba lethu elilawulayo langaphakathi linikeza ukwesekwa okuklanyelwe ukuhlangabezana nezidingo eziqondene nezwe lakho.
v Ikhwalithi efakazelwe kanye nokulungela ukucwaningwa kwamabhuku - Uhlelo lwethu lwekhwalithi luphumelele ukuhlolwa okuningiliziwe okuvela eceleni, futhi imibhalo yethu ihlale igcinwa ilungele ukuhlolwa, iqinisekisa ukuba sobala nokusebenza kahle.
ISIPHETHO:
Njengoba imithethonqubo ithuthuka, nathi sizoba njalo. I-Joytech izibophezele ekunwebiseni ngokuqhubekayo umgwaqo wayo womhlaba wonke wokuthobela ngezitifiketi ezifana ne -FDA ne -MDR —ukuqinisekisa ukuthi ozakwethu bethu banokufinyelela okungaphazamiseki kumadivayisi ezokwelapha aqinisekisiwe, ekhwalithi ephezulu ezimakethe ezilawulwayo.
Sesivele siphethe izitifiketi ezifundeni ezinkulu zomhlaba wonke, okuhlanganisa iNyakatho Melika, i-EU, i-Asia, nangale kwayo.
Uyafuna ukwazi ukuthi sigunyaziwe yini emakethe yakho?
Ufuna isisombululo se-OEM/ODM esilungele ukulawula?
Xhumana nethimba lethu namuhla ukuze uhlole imininingwane yesitifiketi somkhiqizo, imibhalo yezobuchwepheshe, nezixazululo eziklanyelwe iphrojekthi yakho. Nge-Joytech, ukuthobela kuba inzuzo yakho yokuncintisana.
