Whiwhi Tiwhikete EU MDR mō te Uru ki te Mākete Pākehā ngā Pūnaha Whakahauora Raupapa Wanmai Medical DS/VM/DF

I te 28 o Hūrae, 2026, i whiwhi mana ngā mīhini hau DS/VM/DF a Wanmai Medical i te tiwhikete EU MDR, e tohu ana i te otinga angitu o te arotake pakari i raro i ngā ture taputapu hauora hou a te EU mō ngā hua mīhini hau matua a te kamupene. Mā tēnei whakatutukitanga ka hoatu he uruwhenua hou ki te kamupene ki te tomo ki te mākete Pākehā, ā, he tohu anō hoki tēnei i roto i te rautaki whānui o te ao a Wanmai Medical.

Tiwhikete Pūmau

Te whakaatu i te whakataetae o te hua i te ao whānui

Ko te Ture MDR a te EU tētahi o ngā paerewa whakaurunga ture tino pakari i roto i te rāngai taputapu hauora o te ao. Ki te whakatauritea ki te Ture MDD o mua, he nui ake ngā whakaritenga e pā ana ki ngā taunakitanga haumanu mō ngā hua, te whakahaere mōrearea, te whakahaere kounga mō te huringa ora katoa, me te tirotiro i muri i te mākete; he roa te tukanga arotake tiwhikete, he whānui ngā paearu arotake, ā, e mōhiotia whānuitia ana te mana o ana tiwhikete puta noa i te umanga o te ao.

Mā te whiwhi i te tiwhikete MDR e whakaatu ana ko ngā mīhini hauhautanga raupapa DS/VM/DF a Wanmai Medical e whakaatu ana i tō rātou haumaru, whai huatanga, me te mahi hua, e tutuki katoa ana i ngā paerewa hauora pakari o te Kotahitanga o Europi, e āhei ai te hokohoko ture me te tohatoha i ēnei hua puta noa i ngā whenua mema katoa o te EU me te Rohe Ōhanga o Europi. Ehara i te mea he tautoko mana tēnei whakatutukitanga i ngā āheinga R&D a te kamupene, te pūnaha whakahaere whakaputa, me te tohungatanga whakamana haumanu, ā, nā reira ka whakarei ake i te whakataetae whānui o ngā hua a Wanmai i te mākete o te ao, engari kei a ia anō te kaha ki te whakarato i ngā otinga hauhautanga me te tātaritanga kounga teitei mō ngā tūroro o tāwāhi e pā ana ki ngā mate manawa e pā ana ki te moe, me te whakatairanga i te whānui haere o ngā waitohu taputapu hauora Hainamana puta noa i te ao.

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Ngā pakiaka hōhonu me te wheako kua kohia

Mā te mahi toi ka puta he ingoa rongonui puta noa i te ao.

Me ngā tau maha o te tohungatanga ki te rāngai hauora manawa, kua whakatairanga tonu a Wanmai Medical i te kounga me te whakapakari tonu i ngā āheinga hangarau matua o āna hua. I mua, kua whiwhi te kamupene i ngā tiwhikete mana maha i roto i te motu me te ao, tae atu ki te tiwhikete Pūnaha Whakahaere Kounga ISO 13485, te rēhitatanga MHRA i te UK, te tiwhikete MDMA i Saudi Arabia, te tiwhikete ANVISA i Brazil, me te tiwhikete INVIMA i Colombia; ka kaweakehia āna hua ki ngā whenua me ngā rohe maha o te ao, ā, kua whiwhi i te rongonui whānui mai i ngā umanga hauora me ngā kaiwhakamahi mutunga i roto i te motu me te ao.

Ko ia tiwhikete te tohu tino kaha o te whakapau kaha a te hinonga ki te mahi toi, me te whakakaha anō hoki i tōna turanga pakari mō te horapa puta noa i te ao.

Kei te hikoi tonu

Te Whakamana i te Hauora Manawa o te Ao

Mai i tētahi turanga hou, ka tīmata i tētahi haerenga hou, ko te whiwhi i te tiwhikete MDR ehara i te mea he whakamihi anake engari he kawenga anō hoki. I ngā rā kei te heke mai, ka mau tonu a Wanmai Medical ki tana rapunga whakaaro ā-kamupene o te "whakarato hua me ngā ratonga tino pai ki ngā kaiwhakamahi o te ao," ka piki haere tonu te haumi ki te auahatanga R&D, ka piri pono ki ngā ture hauora paerewa teitei o te ao, ka whakapai ake i ngā taputapu tātaritanga me te rongoā manawa he haumaru, he pono, he pai hoki te mahi, ka whakamana i te hauora o te ao me te hangarau Hainamana me te hanga atamai Hainamana, ā, ka tohe tonu ki te kaupapa o te hauora manawa mō te tangata katoa.