Aphranel Officially Obtains EU MDR Certification

ShanghaiJune 3, 2026 /PRNewswire/ — Recently, Moyang Biotechnology announced that its aphranel Youfalan calcium hydroxylapatite (CaHA) microsphere facial injection filler series of 30 specifications has officially received the highest risk level certification under the EU Medical Device Regulation (MDR) from BSI (British Standards Institution).

With this, aphranel Youfalan has become the world’s first Chinese-originated and intelligently manufactured facial injection filler product to obtain MDR certification, and also the first CaHA microsphere facial injection filler product in the Asia-Pacific region to receive this certification.

This certification signifies that aphranel Youfalan fully complies with EU regulatory requirements in terms of safety, efficacy, full lifecycle risk management, and quality system construction, marking that Chinese indigenous innovative medical device companies are participating in global market competition with higher standards.

MDR: The “Passport” for Products Entering the EU Market

The EU Medical Device Regulation (MDR) officially took effect in May 2021, replacing the previous Medical Device Directive (MDD). Compared to MDD, MDR significantly raises the entry threshold for medical devices, imposing stricter requirements on clinical evidence, quality management systems, technical documentation, UDI traceability systems, and post-market surveillance.

After the full implementation of MDR, the transition period for certificates of previously MDD-certified absorbable aesthetic implant products expires on December 31, 2027. Products that have not completed MDR certification by then will no longer be able to circulate compliantly in the EU market.

Against this backdrop, aphranel Youfalan has successfully obtained MDR certification, securing the “European Medical Device Passport.”

From Zero to One: Fulfilling “Long-Termism”

aphranel Youfalan began research and development in 2013, focusing on innovation in CaHA regenerative materials, and received support from China’s national “13th Five-Year Plan” major science and technology project.

After 12 years of R&D accumulation, aphranel Youfalan obtained China’s first NMPA Class III medical device certificate for CaHA microsphere facial injection filler in 2025, selling nearly 150,000 units within a year of launch.

In 2023, aphranel Youfalan officially initiated the MDR certification project. Since the product had no prior MDD certification basis and no directly referable equivalent product certification pathway, aphranel Youfalan had to start from scratch, establishing a quality management system that meets both ISO 13485 standards and all MDR regulatory requirements, and restructuring product technical documentation to comply with the latest regulatory standards.

BSI is one of the founding members of the International Organization for Standardization (ISO) and has long been involved in building global standards systems, promoting timely access to safe and effective medical devices in Europe and global markets. Under BSI’s regulatory review, aphranel Youfalan is not just “meeting standards” but “withstanding scrutiny at the highest global standards.”

MDR certification represents a complete evidence chain for the product, reflecting that the “Time Aesthetics” advocated by aphranel Youfalan is not just a concept but a verifiable evidence-based system, echoing the brand’s “long-termism.” The patented ACD-MT^® microsphere structure, patented PCD-ETT^® gel technology, and clear description of “complete degradation” in aphranel Youfalan products have all become hardcore brand assets validated through international review.

Through solid refinement and breakthroughs from zero to one, aphranel Youfalan demonstrates the foundation of a global high-end brand originating from China.

Europe is Just the First Stop: Advancing Global Market Expansion

In the domestic market, when consumers and doctors choose aphranel Youfalan, they are not only choosing the first CaHA category NMPA Class III facial certificate in China but also the dual assurance of MDR certification. aphranel Youfalan will continue to deepen compliance, academic research, and clinical delivery, making the word “peace of mind” carry more weight.

For the global market, MDR certification will provide momentum for aphranel Youfalan to enter more international markets. Meanwhile, the “Nuo’en Plan” global regenerative aesthetics exchange platform initiated by Moyang Biotechnology has officially launched, aiming to define the world standard of “Time Aesthetics” together with more overseas experts.

Obtaining MDR certification is a new starting point for Moyang Biotechnology’s globalization. aphranel Youfalan will continue to deepen and refine its work in the CaHA track, develop more innovative products, and promote the application and development of Chinese original regenerative aesthetic technology worldwide.