UMT Obtained the First Batch of MDR CE Certificates in China
United Medical Technologies, obtained the emergency filing certificate of disposable medical mask and medical surgical mask on February 29. On May 14, UTM successfully obtained the CFDA class II Registration Certificate of disposable medical mask and medical surgical mask. On May 19, UMT appeared on theName List of Medical Devices and Supplies Companies with Certification/Authorization from other Countries. (commonly known as "white list") of China Chamber of Commerce for the Import and Export of Medical and Health Products, and recently obtained CE certificate on June 15, 2020, which is the first CE certificate under the framework of the new EU regulation MDR.
This means that with the tenet of "profession, focus, innovation and service", the good quality system, as well as safe, efficient and standard production mode have been recognized by EU regulations, and the products can enter the EU market in a more legal and compliant way, contributing to the overseas anti-pandemic situation.
對于MDD而言，MDR是全方位的升級，因此對于醫療器械公司的質(zhì)量體系是一個(gè)挑戰。優(yōu)特醫療在短期內將自身的質(zhì)量體系升級到符合MDR法規要求，并且順利通過(guò)了審核。
這意味著(zhù)優(yōu)特醫療以“專(zhuān)業(yè)、專(zhuān)注、創(chuàng )新、服務(wù)”的宗旨，良好的質(zhì)量體系、安全高效、標準生產(chǎn)的模式獲得了歐盟法規的認可，優(yōu)特醫療的產(chǎn)品能夠更加合法合規地進(jìn)入歐盟市場(chǎng)，為海外疫情貢獻出一份力量。
