#China #Shanghai #Aphranel #CaHA Filler #MagiCCrystal

Aphranel® MagiCCrystal Achieves EU MDR Certification

Moyom Biotechnology has reached a significant milestone with its premium regenerative aesthetics product, Aphranel® MagiCCrystal CaHA Filler, officially receiving the EU MDR certification on May 18, 2026. This certification positions Aphranel among the forefront of injectable regenerative fillers within the Asia-Pacific region, being one of the first to obtain this status directly under the EU Medical Device Regulation (EU MDR).

The certification signifies that Aphranel meets the rigorous quality management, clinical evaluation, manufacturing standards, safety, traceability, and post-market surveillance regulations mandated by the European Union. Since the EU MDR was implemented in May 2021, stricter compliance has been enforced for medical devices, meaning that any device lacking MDR certification after December 31, 2027, will be barred from the EU market.

The journey to certification took approximately two years and seven months using the Class III pathway, specifically designed for high-risk absorbable implantable medical devices. Notably, the process was conducted with the collaboration of BSI, a UK-based notified body recognized as the first organization designated by the MDR globally.

During its initial global expansion, Moyom Biotechnology was advised to adopt a European brand identity for international markets. However, the founder emphasized a different vision: “We believe that a global regenerative aesthetics brand can emerge from China.” This vision continues to influence the company’s long-term international strategy.

Historically, the field of calcium hydroxyapatite (CaHA) regenerative aesthetics has been led by a limited number of international manufacturers, with few significant technological advancements in the past decade. Aphranel stands out by focusing on in-house R&D, centering on fully biodegradable CaHA materials, improving microbead structural design, validating degradation pathways, and enhancing manufacturing processes.

Aphranel's long-term development strategy prioritizes product excellence. Following the first Class III approval in China for a newly designed CaHA injectable facial filler, the company has refined its biomaterial formulation further and conducted long-term safety studies, resulting in clinical follow-up data that spans up to 39 months. The product instructions confirm a complete in vivo biodegradation, compliant with clinical and regulatory standards.

Formulated with 30% CaHA microspheres and 70% CMC carrier gel, the Aphranel injectable offers immediate structural support while promoting collagen regeneration through bio-stimulating mechanisms. Key technologies driving this innovation include the patented ACD-MT® microsphere structure and PCD-ETT® gel technology. The CaHA microspheres, measuring approximately 30-35 μm, feature a raspberry-like porous structure that facilitates tissue integration and collagen regeneration. Notably, the material has an approximate G' value of 5,500 Pa, ensuring injection stability while supporting gradual biodegradation.

Crucially, the product is free from residual crosslinking chemical agents. As the material biodegrades, calcium ions are naturally metabolized within the body, promoting long-term tissue compatibility.

In China’s high-end medical aesthetics market, Aphranel positions itself as a premium regenerative injectable, with a recommended retail price of 12,800 RMB for a 0.5 ml syringe. The brand has also introduced a concept called “The Poetics of Time,” emphasizing its commitment to regenerative aesthetics, gradual improvement, and long-lasting structural results.

In January 2026, Aphranel showcased its innovations at IMCAS Paris 2026, one of the leading global congresses in aesthetic medicine, thus elevating its international academic and professional presence. Achieving MDR certification marks a pivotal advancement for Moyom Biotechnology in the global evolution of regenerative aesthetics through biomaterials innovation, clinical research, and international collaboration.