ʻO nā mea hana Kina i hoʻokuʻu ʻia - ma lalo o ke kaomi mau ʻana mai nā mea hou MDR EU, hoʻonui ʻia ka nānā ʻana o FDA, a me ka koi ʻana i nā loiloi mea hoʻolaha - ua hoʻolilo nui i nā ʻōnaehana maikaʻi, nā lako kikoʻī, a me nā palapala hōʻoia honua i nā makahiki i hala. ʻO ka hopena, he mākeke bifurcated: nā hale kūʻai kūʻai e hana ana i nā huahana i hoʻokaʻawale ʻole ʻia ma kekahi ʻaoʻao, a me nā hoa hana OEM kūpono maoli e hana ana i nā ʻōnaehana maikaʻi like me nā mea hana ʻaelike Western ma kekahi.