Shanghai, December 2025 — The clear aligner solutions from Angelalign Technology Inc. (“Angel Aligner”) received the MDR certification from TÜV SÜD, a leading notified body in medical device industry.
The certification marks Angel Aligner’s achievement of Class IIa MDR certification and CE marking, reflecting a significant advancement in product quality, safety, and regulatory standards, and demonstrating the company’s continued investment in clinical evidence and robust quality systems.
Issued under the EU Medical Device Regulation (MDR), one of the most stringent medical device regulatory frameworks worldwide, the CE certificate is granted only after a comprehensive, multi-round assessment. The evaluation covers multiple dimensions, including product technology, clinical evaluation, quality management systems, and post-market surveillance, reflecting the high regulatory threshold required for market access.
Mr. Fox Hu, Angel Align Inc’s CEO, noted that the certification reflects the Company’s long-term focus on innovation, quality management, and regulatory compliance. Since launching its globalization strategy, Angel Aligner has prioritized entry into developed markets such as Europe and North America, benchmarking against international best practices while adapting to local clinical workflows and professional standards.
Through a highly localized approach, Angel Aligner continues to optimize its products and services for orthodontists worldwide. After more than two years of global expansion, its business has grown rapidly, with non-China cases accounting for over 50% of total case volume in the first half of this year, and operations spanning more than 60 countries.
“Safety is always the core of medical devices,” said Ms. Irene Chen, Vice President of Medical and Health Services, Greater China, TÜV SÜD. “Angel Aligner’s decision to pursue certification under MDR reflects a strong commitment to patient safety and product excellence.”
The MDR-CE certification strengthens Angel Aligner’s competitive position in the global clear Aligner market and underscores the Company’s commitment to safety, quality, and sustainable globally growth.
