Joytech Medical ye EU Quality Management System Certificate (MDR) sɔrɔ min dira TüVSüD SÜD fɛ awirilikalo tile 28 san 2022. Seereyaw kɔnɔkow ye : nizɛri funteni jateminɛnan, tansiyɔn sɛgɛsɛgɛlikɛlan, tulo sumayɔrɔ infirɛri, ɲɛda funteni jateminɛnan infirɛri, ɲɛda funteni jateminɛnan min bɛ baara caman kɛ , kuran sinji pɔnpe, bolola sinji pɔnpe. O ye Sinuwa jamana ka tɔn fɔlɔ dɔ ye min ye CE sariya labatoli seere sɔrɔ sariya kura MDR wajibiyalenw kɔnɔ, wa a ye MDR seere fɔlɔ ye sokɔnɔna ɛntɛrinɛti funteni jateminɛnanw, tulo sumanikɛlan infirɛriw ani barajuru pɔnpew la.
Joytech Medical ye furakɛli minɛnw baarakɛda ye min sinsinnen bɛ furakɛli minɛnw ɲinini ni u labɛnni, u dilanni n’u feereli kan kɛnɛya kɔlɔsili ni bana basigilenw kunbɛnni kama. Kabini a sigira sen kan, a lakodɔnnen don iko jamana ka seko ni dɔnko baarakɛyɔrɔ ani fɛɛrɛ kɔrɔlen R&D santiri baarakɛyɔrɔ ye Hangzhou. Joytech Medical ye ISO13485, MDSAP ani jogoɲumanya ɲɛnabɔcogo wɛrɛw tɛmɛn. An ka fɛn dilannenw ye NMPA, Ameriki FDA, EU CE, Kanada CMDCAS, Japon PMDA ani seereyaw ni sɛbɛnni wɛrɛw sɔrɔ jamana kɔnɔ, wa u sɔnna ka feere. Wa an sera jɛkafɔ kuntaalajan na ni baarakɛda tɔgɔba caman ye jamana kɔnɔ ani jamana kɔkan.
EU bɛ ka jɔ dɔɔnin dɔɔnin ka kɛ suguba kelen ye walasa ka jago gɛlɛyaw ban jamanadenw ni ɲɔgɔn cɛ ani ka mɔgɔw, baarakɛminɛnw, waribonw ani fɛnw (i n’a fɔ furakɛli minɛnw) ka taa hɔrɔnya la. Furakɛminɛnw siratigɛ la, Erɔpu Komisiɔn ye UE ka cikan saba labɛn walasa ka jamana kelen-kelen bɛɛ ka laseli kɛcogo fɔlɔ bila u nɔ na, walasa sariya minnu ɲɛsinnen bɛ o fɛn suguw feereli ma, olu ka se ka bɛn ɲɔgɔn ma.
EU ka MDR bɛ tali kɛ furakɛli minɛnw sariyasun (MDR) ofisiyali la min bɔra EU fɛ (Dɔgɔtɔrɔso minɛnw sariyasun (UE) 2017/745), min sinsinnen bɛ MDR sariyasen 123nan ka ɲininiw kan. MDR donna baara la san 2017 mɛkalo tile 26, wa a bɛ furakɛli minɛn kɔrɔw ka cikan kɔrɔ (MDD 93/42/EEC) nɔ bila foroba la ka ɲɛsin furakɛli minɛnw baarakɛcogo ma (AEDD) k’a daminɛ mɛkalo tile 26 san 2020 , n’o ye dɔgɔtɔrɔso minɛnw bilali sariya ye (AIMDD 90/385/EEC).
Ni an y’a suma ni furakɛli minɛnw ɲɛfɔli ye (MDD), MDR ka gɛlɛn kosɛbɛ fɛn dilannenw ka faratiw kunbɛnni siratigɛ la, fɛn dilannenw ka baarakɛcogo n’u lakanani sariyaw, kɛnɛyaso jateminɛni, ani fana sugu kɔfɛ kɔlɔsili ani furaw kɔlɔsili. O fana ye gɛlɛyaba ye dilanbaga ka jogoɲini siratigɛ la ani a ka fɛn dilannenw lakanani nafa la.
MDR ka seereyaw sɔrɔli ɲɛtaa bɛ Joytech Medical ka fɛn dilannenw hakɛ n’u jogo ɲuman jira ani UE suguya dɔnni. Joytech Medical bɛna MDR CE seereyaw ta k’a kɛ yiriwali sira kura ye walasa ka diɲɛ suguya labɛncogo juguya ka taa a fɛ ani ka dɛmɛ don diɲɛ furakɛli baara la.
