Group 1 - The core viewpoint of the news is that Times Angel Biotechnology Co., Ltd. has received the MDR-CE certification from TÜV Rheinland, marking a significant step in meeting EU medical device regulations and enhancing its market credibility in high-standard overseas markets [1][2] - The MDR-CE certification indicates that Times Angel's products comply with the EU's stringent safety, effectiveness, and compliance requirements for medical devices, which involves a rigorous multi-dimensional review process by a recognized Notified Body [1] - TÜV Rheinland is recognized globally for its authority in medical device certification, and the MDR-CE certification is considered one of the most stringent regulatory frameworks worldwide [1] Group 2 - The CEO of Times Angel stated that the CE certification is a result of the company's long-term investment in product development, quality systems, and compliance capabilities, as well as the strict requirements set by TÜV Rheinland [2] - Since initiating its globalization strategy, Times Angel has prioritized entry into developed markets such as Europe and the United States, necessitating alignment with the highest standards in regulations, data security, product quality, and certification processes [2]
时代天使获TÜV南德首张隐矫产品欧盟MDR-CE证书 全球化战略再进一步