Labari Mai Daɗi!IVDR CECtakardar shaida ta ACCUGENCE®Pkayayyaki  

A ranar 11 ga Oktoba, tsarin ACCUGENCE Multi-Monitoring System ACCUGENCE® Multi-Monitoring Meter (ACUGENCE Blood Glucose, Ketone da Uric Acid Analysis System, gami da Meter PM900, Blood Glucose Strips SM211, Blood Ketone Strips SM311, Uric Acid Strips SM411, da sauransu)sun sami takardar shaidar IVDR ta Class C.

Ta hanyar samun takardar shaidar IVDR CE da TÜV SÜD ta bayar, hukumar da Tarayyar Turai ta sanar, wacce muhimmin mataki ne mai muhimmanci a ci gaban ACCUGENCE®, kuma alama ce mai girma a cikin tsarin binciken kasuwar e-LinkCare ta ƙasashen waje.

Game da IVDR

Dokar Na'urorin Lafiya ta Tarayyar Turai (IVDR), wacce ta fara aiki a ranar 25 ga Mayu, 2017 kuma aka aiwatar da ita a ranar 26 ga Mayu, 2022, tana da buƙatu masu ƙololuwa da yawa don sake duba fasaha, kimantawa ta asibiti, da kuma kula da kasuwa na na'urorin lafiya na in vitro don tabbatar da aminci, inganci, da ingancin samfuran.

A bisa ƙa'idodin na'urorin likitanci na EU a cikin vitro, samun takardar shaidar IVDR CE sharaɗi ne mai mahimmanci don samun damar samfura zuwa kasuwar EU, watau, samfurin ya sami "visa" don shiga kasuwar Turai.

Gaskiyar cewa samfuranmu na iya samun takardar shaidar IVDR CE yana nuna cewa AIKInmu®Tsarin Kulawa da Yawa ya cika manyan buƙatun kasuwar Tarayyar Turai dangane da ingancin samfura, aminci da inganci, da kuma matakin fasaha, da kumakumamatakin kula da inganci ya kai matsayin ƙasashen duniya.