I-JoyTech Medical yanikezwa isitifiketi Sokulawulwa Kwekhwalithi Ye-EU (MDR) ikhishwe nguTüvsüd Süd ngo-Ephreli 28, 2022. Ububanzi besitifiketi buhlanganisa: I-Digital Thermometer, Umfutho wegazi uqapha, I-thermometer endlebeni ye-infrared, ibunzi le-infrared thermometer, i-multifunction ebunzini thermometer , iphampu yebele kagesi, iphampu yebele ngesandla. Ngenye yezinkampani zakuqala eChina ukuthola isitifiketi sokuhambisana ne-CE ngaphansi kwezidingo ezintsha ze-MUTRONETET RETROCE, futhi iyisitifiketi sokuqala se-MDR yama-thermometers asekhaya, ama-thermometer endlebe angenamkhawulo.
I-JoyTech Medical yibhizinisi ledivayisi yezokwelapha eligxile ku-R & D, ukukhiqizwa kwamadivayisi wezokwelapha wokuqapha impilo kanye nokuphathwa kwezifo okungamahlalakhona. Kusukela ukusungulwa kwayo, inkampani iye yaqashelwa njengebhizinisi lobuchwepheshe obuphakeme kakhulu kanye ne-High-Tech R & D Centre Enterprise e-Hangzhou. I-JoyTech Medical idlulise i-ISO13485, MDAP kanye nezinye izinhlelo zokuphathwa kwekhwalithi. Imikhiqizo yethu ithole i-NAMPA yasekhaya, i-US FDA, e-EU CE, eCanada Cmdcas, iJapan PMDA kanye nezinye izitifiketi kanye nokubhalisa, futhi ivunyelwe ukumaketha. Futhi sesifinyelele ukubambisana kwamasu isikhathi eside namabhizinisi amaningi adumile asekhaya nakwamanye amazwe.
I-EU yakha kancane kancane emakethe enkulu ebumbene ukuqeda izithiyo zokuhweba phakathi kwezindawo ezingamalungu futhi iqinisekise ukuhamba kwamahhala kwabantu, izinsizakalo, imali kanye nemikhiqizo (njengamadivaysi ezokwelapha). Emkhakheni wamadivayisi wezokwelapha, iKhomishini YaseYurophu isungule imiyalo emithathu ye-EU ukumiselela uhlelo lokuqala lokugunyazwa lwezwe ngalinye lelungu, ukuze iziqondiso eziphathelene nokumaketha kwemikhiqizo enjalo zingavunyelwa.
I-EU MDR isho umthetho osemthethweni we-Medical Regulation (MLDR) okhishwe yi-EU (I-Medical Regulation (EU) 2017/745), ngokususelwa kwizidingo ze-Article 123 ze-MDR. I-MDR yangena yaba namandla ngoMeyi 26, 2017 futhi yathatha isikhundla ngokusemthethweni kwalowo owayengumqondisi wedivaysi yezokwelapha (MDD 93/42 / EEC) kanye ne-Active Medical Desiteive (AEDD) kusukela ngoMeyi 26, 2020, amadivaysi ezokwelapha angenakufinyeleleka (aimDD 90/385 / EEC).
Uma kuqhathaniswa nesiqondisi sedivayisi yezokwelapha (MDD), i-MDD iqinile ngokwengeziwe ngokulawulwa kobungozi bomkhiqizo, ukusebenza komkhiqizo kanye namazinga okuphepha, ukuhlolwa kwemitholampilo, kanye nokuqapha ngemuva kokuphaphama kanye nokugadwa kwemikhiqizo. Kuyinselele enkulu ohlelweni lokuphathwa kwekhwalithi yomkhiqizi kanye nokusebenza kokuphepha komkhiqizo.
Ukuzuzwa okuphumelelayo kwesitifiketi se-MDR kukhombisa okujwayelekile kanye nekhwalithi yemikhiqizo yezokwelashwa ye-Joytech kanye nokuqashelwa kwemakethe ye-EU. I-JoyTech yezokwelapha izothatha isitifiketi se-MDR CE njengethuba elisha lentuthuko lokukhulisa ukwakheka kwemakethe yomhlaba kanye negalelo embonini yezokwelapha emhlabeni jikelele.
