Haiyan Kangyuan Medical Meafaigaluega Co., Ltd. na maua manuia le EU medical Instruments regulations (EU 2017/745, e taʻua o le "MDR") tusi faamaonia i le aso Fepuari 1, 2023, o le numera o le tusi faamaonia o le 6122159CE01, ma le lautele o le faʻamaonia e aofia ai Endotracheal Tubes mo Faʻaaoga Tasi, Sterile Suction Catheter mo le Fa'aoga Tasi, Masks Oxygen mo le Fa'aoga Tasi, Nasal Oxygen Cannulas mo le Fa'aoga Tasi, Guedel Airways mo le Fa'aoga Tasi, Laryngeal Mask Airways, Masks Anesthesia mo le Fa'aoga Tasi, Fa'amama manava mo Fa'aoga Tasi, Ta'amilosaga manava mo Fa'aoga Tasi.

Ua lipotia mai o le EU Medical Instrument Regulation MDR (EU 2017/745) na amata faamamaluina ia Me 25, 2017, e suitulaga i le Medical Instrument Directive MDD (93/42/EEC) ma le Active Implantable Medical Instrument Directive AIMDD (90/385). /EEC), o lo'o fa'amoemoe e fa'atūina se fa'aonaponei ma fa'amamafa faiga fa'atonutonu e puipuia atili ai le soifua maloloina ma le saogalemu o tagata lautele ma gasegase. Faatasi ai ma i latou, ua tuʻuina atu e le MDR ni manaʻoga sili atu mo tagata gaosi mea faigaluega faʻafomaʻi e tusa ai ma le faʻafoega o tulaga lamatia o oloa, faʻatinoga o oloa ma tulaga saogalemu, suʻesuʻega falemaʻi, ma le mataala ma le vaʻavaʻa. Pe a faʻatusatusa i le faʻatonuga a le MDD, o le MDR faʻatonutonu e sili atu le malosi o le vaavaaiga, sili atu ona faigata le faʻamaonia, ma sili atu le gauai atu i le saogalemu ma le aoga o oloa.

Ua maua manuia e le Kangyuan Medical le tusi faamaonia o le MDR i lenei taimi, lea e faʻamaonia atoatoa ai ua ausia e oloa Kangyuan le aloaia o le EU ma maketi faava o malo i tulaga o le puleaina o gaosiga, faʻamautinoaga lelei ma le puleaina o lamatiaga.

Mo Kangyuan Medical, lea na matua aafia i le maketi a Europa mo le silia ma le sefulu tausaga, o le mauaina o le tusi faamaonia MDR o se mea taua. , Amerika Latina ma isi maketi na maua ai le lagolago malosi.