#China #Shanghai #Moyom Biotechnology #Aphranel #CaHA Filler

Aphranel® MagiCCrystal CaHA Filler Secures EU MDR Certification

In a notable development for the field of regenerative aesthetics, Moyom Biotechnology has announced that its premium product, Aphranel® MagiCCrystal CaHA Filler, officially received certification under the EU Medical Device Regulation (EU MDR). This certification, which was granted on May 18, 2026, distinguishes Aphranel® as one of the first regenerative injectable calcium hydroxylapatite (CaHA) fillers from the Asia-Pacific region to achieve such recognition.

Meeting Rigorous Standards

The EU MDR certification confirms that Aphranel® adheres to the stringent regulatory requirements set by the European Union, encompassing essential areas such as quality management, clinical evaluation, safety, traceability, and post-market surveillance. The updated Medical Device Regulation has replaced the former Medical Device Directive and introduced significantly stricter compliance mandates for all medical products on the European market. It is worth noting that products without MDR certification will no longer be permitted in the EU market after December 31, 2027.

The certification process was extensive, spanning two years and seven months, and followed the Class III MDR pathway for high-risk absorbable implantable medical devices. Importantly, Moyom Biotechnology completed the conformity assessment process with BSI, a leading UK-based notified body and the first organization designated for MDR compliance worldwide.

A Global Vision

During Aphranel's early global expansion, the company faced advice to adopt a European brand identity for reaching international markets. However, the founder of Aphranel maintained that “a global brand for regenerative aesthetics can emerge from China,” a stance that continues to influence the company's long-term international strategy.

Historically, CaHA technologies in regenerative aesthetic medicine have been led by a limited number of international manufacturers with minimal technological advancements. Aphranel, however, has taken a different path through proprietary research and development focusing on fully biodegradable CaHA materials, enhancing microsphere structural design, de facto degradation pathways validation, and manufacturing optimization.

Strategic Development Philosophy

Aphranel employs a product-focused, long-term development strategy. It has not only achieved China’s first Class III medical approval for an injectable CaHA microsphere facial filler but has also refined the design of its biomaterial formulation. This includes extended safety studies, with clinical follow-ups lasting up to 39 months.

The product’s instruction manual highlights its complete biological degradation in vivo, a feature validated by clinical and regulatory standards. The injectable CaHA facial filler comprises 30% CaHA microspheres and 70% CMC gel carrier, designed to deliver immediate structural support while stimulating collagen regeneration through biostimulatory mechanisms.

Core Technologies

Among its core technologies are patented structures like ACD-MT® CaHA microsphere structure and PCD-ETT® gel technology. The CaHA microspheres are approximately 30-35 μm in size, featuring a raspberry-shaped porous structure intended to promote tissue integration and collagen regeneration, all while providing injection stability with a G'-value of around 5500 Pa. The absence of chemical cross-linkers ensures the material naturally metabolizes calcium ions in the body, enhancing long-term tissue compatibility.

Positioned as a high-end regenerative injectable product in China's aesthetic market, Aphranel® is recommended for sale at 12,800 RMB per 0.5 mL syringe. Adding to its innovative edge, the brand has introduced the concept of the “Poetics of Time,” emphasizing gradual improvement and sustainable structural outcomes in regenerative aesthetics.

Aphranel made its mark at the IMCAS Paris 2026, one of the world’s premier congresses for medical aesthetics, showcasing its commitment to expanding its international academic and professional reach. This EU MDR certification signifies Moyom Biotechnology's contribution to the global advancement of regenerative aesthetics through biomaterial innovation, clinical research, and international collaboration.