Ua hāʻawiʻiaʻo ka Membertech Medication i ka Palapala Kū'ē Kū'ē Kū'ē Nui (MDR) i hoʻopukaʻia e Tüvsüd Süd maʻApelila 28, 2022. 'ōhua trmomometer, ʻO ke kiaʻi, ʻO ka pepeiao pepeiaoʻo ka pepeiao, i waho ka wahine i hanaʻia, mismomyer, mustifanction sorol the thermometer, celcties burt pump. ʻO ia kekahi o nāʻoihana mua ma Kina e loaʻa i ka palapala hōʻoia ma lalo o nā koina MDR e pili ana i ka Pūnaewele MDR.
ʻO kaʻoliʻoli o ka olakino kahi mea lapaʻau lapaʻau e pili ana i ka R & D, e hana ana a me ke kūʻaiʻana o nā mea lapaʻau olakino Mai kona hoʻokumuʻana, uaʻikeʻia ka hui me he hui kiʻekiʻe o kaʻenehana a me nāʻoihana kiʻekiʻe a me kahiʻoihana kiʻekiʻe ma Hangzhou. Ua halaʻo ka hauʻoli o ka hauoli me ka iso134885, mssap a me nā'ōnaehana hoʻokele maikaʻi. Loaʻa iā mākou nā huahana i nā NMPA i loaʻa iā US FDPA, US FDA, EU CE, CARD CMDCAS, a me nā papa inoa inoa a me nā hale kūʻai aku. A ua hōʻea mākou i ka hana maʻamau lōʻihi me nāʻoihana kaulana nui me nāʻoihana kaulana loa ma ka home a ma waho aku.
Ke kūkulu nui nei ka EU i kahi mākeke nui e hoʻopau i nā mea kūʻai aku ma waena o nā mea kūʻai aku ma waena o nā kānaka a me nā lawelawe manuahi (e like me nā huahana olakino. Ma ke kahua o nā limahana lapaʻau, ua hoʻomohalaʻia ke komisina oʻEulopa e pili ana i nā papa kuhikuhi EU e pili ana i kēlā me kēiaʻano hana o kēlā
ʻO ka mea e pili ana ka EU MDR i ka hoʻoponoponoʻana i ka mea hoʻoponopono pilikino (MDR) i hoʻopukaʻia e ka EU (EU) Reging (EU) 2017 Ua komo ka MDR i ka ikaika ma Mei 26, 2017 a me ke kuhikuhiʻana i ka papa kuhikuhi ma mua (MDDATER 93 / AEDD
Hoʻohālikelike i nā papa kuhikuhiʻenehana (MDD),ʻoi aku ka maikaʻi o ka MDR i nāʻano loiloi o ka huahana,ʻoi aku ka palekana. He paʻakikī nui hoʻi ia i ka'ōnaehana hoʻokele a me ka hopena palekana palekana.
ʻO ka hoʻokō kūleʻa o ka hōʻoia o MDR e hōʻike ana i nā kūlana kiʻekiʻe a me ka maikaʻi o nā huahana o kaʻoliʻoli a me ka hoʻomaopopoʻana o ka mākekeʻo EU. E lilo i ka hauʻoli olakino e lawe i ka hōʻoia o MDR CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CO CONPE EXPET EXEPN WELLT WELLTY A ME KA PILI ANA I KE KOLOHE ANA.
