aphranel®优法兰®羟基磷酸钙（CaHA）微球面部注射填充剂正式获得欧盟MDR认证
On May 18, 2026, aphranel®, the regenerative aesthetics brand developed by Moyom Biotechnology, officially obtained European Union Medical Device Regulation (EU MDR) certification for its Calcium Hydroxylapatite (CaHA) Microsphere Injectable Facial Filler.
With this achievement, aphranel® becomes the only CaHA product in the Asia-Pacific region certified under the EU MDR framework, marking an important milestone in the company's international development and regulatory strategy.
Advancing Through One of the World's Most Stringent Regulatory Frameworks
Implemented in May 2021, the EU Medical Device Regulation (MDR) replaced the former Medical Device Directive (MDD) and introduced significantly higher requirements across clinical evaluation, quality management, technical documentation, traceability, manufacturing standards, and post-market surveillance.
Unlike previous regulatory pathways, MDR requires substantially greater levels of clinical evidence, risk management, and lifecycle oversight. Medical devices that fail to obtain MDR certification before the end of the transition period will no longer be permitted to remain on the European market.
To pursue certification, Moyom Biotechnology selected the MDR Class III pathway for high-risk absorbable implantable medical devices. The conformity assessment process was completed in collaboration with BSI, the UK-based Notified Body recognized as the world's first MDR-designated organization.
The certification journey spanned 2 years and 7 months, reflecting the company's commitment to meeting international regulatory standards across every stage of product development, manufacturing, quality management, and post-market compliance.
Built on Long-Term Biomaterial Innovation
As a regenerative aesthetics brand specializing in Calcium Hydroxylapatite (CaHA) biomaterials, aphranel® has consistently pursued a product-led and long-term development strategy.
The company's research focuses on fully biodegradable CaHA materials, integrating microsphere structure design, degradation pathway validation, and manufacturing optimization into a comprehensive biomaterial platform.
aphranel's injectable facial filler utilizes a formulation composed of 30% CaHA microspheres and 70% CMC gel carrier, designed to provide immediate structural support while promoting collagen regeneration through biostimulatory mechanisms.
Its core technologies include:
* ACD-MT® Patented CaHA Microsphere Technology
* PCD-ETT® Patented Gel Technology
The CaHA microspheres measure approximately 30–35 μm and feature a raspberry-shaped porous structure designed to support tissue integration and collagen regeneration.
With a G' value of approximately 5500 Pa, the material is engineered to provide strong structural support and injection stability while maintaining gradual biodegradation characteristics.
The formulation contains no residual chemical cross-linking agents, and the product instructions specify complete in vivo biodegradation.
To date, aphranel® has completed clinical follow-up studies extending up to 39 months, supporting its long-term safety and performance profile.
A Premium Regenerative Injectable Developed in China
aphranel® previously obtained China's first Class III medical device approval for an original CaHA microsphere injectable facial filler.
Today, the product is positioned within China's premium regenerative aesthetics market, with a recommended retail price of RMB 12,800 per 0.5 mL syringe.
The brand's development philosophy is guided by "The Poetics of Time" — an approach that emphasizes regenerative aesthetics, gradual improvement, and long-term structural harmony rather than short-term transformation.
From China to the Global Stage
In January 2026, aphranel® presented its regenerative aesthetics philosophy and biomaterial research at IMCAS Paris 2026, one of the world's leading medical aesthetics congresses.
The company continues to participate in international academic exchanges, clinical collaborations, and professional forums across regions including the Middle East, Europe, Southeast Asia, and Latin America.
For Moyom Biotechnology, the achievement of EU MDR certification represents more than a regulatory milestone. It reflects the company's ongoing commitment to advancing regenerative aesthetics through biomaterial innovation, scientific research, and global collaboration.
As aphranel® continues its international expansion, the company remains focused on delivering regenerative aesthetic solutions grounded in science, safety, and long-term value.