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

Aphranel® MagiCCrystal CaHA Filler Secures EU MDR Certification

Moyom Biotechnology has made a significant advancement in the field of aesthetic medicine with its premium product, Aphranel® MagiCCrystal CaHA Filler, which has officially acquired certification under the European Medical Device Regulation (EU MDR), effective May 18, 2026. This certification signifies that the product meets the stringent regulatory requirements of the European Union regarding quality management, clinical evaluation, manufacturing standards, safety, traceability, and post-market surveillance.

Aphranel® is one of the first regenerative injectable fillers based on calcium hydroxyapatite (CaHA) in the Asia-Pacific region to obtain such certification directly under the EU MDR regulation, highlighting its premium nature in the market.

The EU's Medical Device Regulation (MDR) replaced the older Medical Device Directive (MDD) in May 2021, imposing more rigorous compliance requirements for medical devices across Europe. As of December 31, 2027, any medical devices that are not MDR certified will no longer be permitted on the EU market, making Aphranel's certification crucial for its continued availability in Europe.

The certification process for Aphranel spanned two years and seven months, navigating through the mandated procedures for class III high-risk resorbable implantable medical devices, without relying on equivalence pathways or exemptions. Moyom Biotechnology collaborated with BSI, the UK's notified body and the first organization designated for MDR globally, to ensure compliance.

Despite recommendations to adopt a European brand identity for global markets, the founder of Aphranel believes in establishing a global regenerative aesthetics brand emerging from China. This perspective has influenced the company's long-term international strategy profoundly.

Traditionally, the CaHA-based regenerative medical aesthetics space has been dominated by a limited number of international manufacturers, with minimal technological advancements over the past decade. Aphranel is breaking the mold by engaging in exclusive R&D activities focusing on fully biodegradable CaHA materials, enhancing microsphere structural design, validation of degradation pathways, and optimizing manufacturing processes.

In addition to securing the first class III medical device authorization in China for an original injectable facial filler based on CaHA microspheres, Aphranel has continued refining the design of its biomaterial formulation while conducting long-term safety studies, demonstrating a commitment to clinical follow-up for up to 39 months.

Instructions for the product indicate complete in vivo biodegradation, validated by clinical and regulatory compliance standards. Aphranel's injectable facial filler comprises 30% CaHA microspheres and 70% carboxymethylcellulose (CMC) gel, providing immediate structural support and stimulating collagen regeneration through biostimulation mechanisms.

Key technologies utilized include the patented ACD-MT® CaHA microsphere structure and PCD-ETT® gel technology. The CaHA microspheres, measuring approximately 30-35 μm, feature a raspberry-like porous structure designed to promote tissue integration and collagen regeneration. The injectable material offers a stability value (G') of about 5500 Pa, ensuring injection stability while still allowing for gradual biodegradation.

Free of residual chemical cross-linking agents, the product's biodegradable material releases calcium ions that are naturally metabolized by the body, enhancing long-term tissue compatibility.

In the high-end medical aesthetics market of China, Aphranel is positioned as a premium regenerative injectable product, priced at approximately 12,800 RMB for a 0.5 ml syringe.

Furthermore, Aphranel has introduced the concept of