Aphranel® MagiCCrystal CaHA Filler Achieves EU Certification as a Premium Injectable

Aphranel® MagiCCrystal CaHA Filler Achieves EU MDR Certification

Moyom Biotechnology has officially announced that its innovative product, Aphranel® MagiCCrystal CaHA Filler, has successfully obtained certification under the European Union Medical Device Regulation (EU MDR) as of May 18, 2026. This designation solidifies Aphranel® as a premium regenerative injectable within the European market.

Aphranel® MagiCCrystal CaHA Filler stands out as one of the pioneering regenerative calcium hydroxylapatite (CaHA) injectable fillers from the Asia-Pacific region to achieve this certification, attesting to its compliance with the rigorous standards imposed by the EU regulations. These encompass quality management, clinical evaluation, manufacturing practices, safety protocols, and post-market oversight.

The EU MDR, which began implementation in May 2021, replaced the previous Medical Device Directive (MDD) with a stricter regulatory framework for medical devices available throughout Europe. As a result of these new regulations, any medical device lacking appropriate MDR certification by December 31, 2027, will be prohibited from the EU market. This highlights the importance of timely compliance and the challenges faced by manufacturers.

The certification process for Aphranel® took an extensive duration of two years and seven months, navigating through the challenging MDR Class III pathway tailored for high-risk absorbable implantable devices. This pathway demands a thorough assessment that does not allow for equivalence routes or exemptions, marking the significance of Aphranel’s achievement.

In partnership with BSI, the United Kingdom’s recognized Notified Body and the first organization designated for MDR compliance, Moyom Biotechnology has successfully completed the conformity assessment necessary for the certification.

During the initial phase of Aphranel’s global outreach, there were suggestions to adopt a European brand identity for broader acceptance in international markets. However, the founder of Aphranel was resolute in their belief that a globally recognized regenerative aesthetics brand could originate from China, a sentiment that continues to shape the company's long-term global strategies.

In the regenerative medical aesthetics sector, CaHA technologies have been largely dominated by a few international players, with little progression in terms of technological innovation over the past decade. Aphranel, however, has taken a different approach, focusing on proprietary research and development centered around fully biodegradable CaHA materials. This includes advancements in microsphere structural design, validation of degradation pathways, and enhancements in manufacturing processes.

Aphranel maintains a product-centric and sustainable developmental strategy. It has not only been at the forefront of China's first Class III medical device approval for an original CaHA microsphere injectable facial filler but has also continued to refine its biomaterial formulation and conduct long-term safety trials reaching up to 39 months.

The formulation for Aphranel® includes a unique blend of 30% CaHA microspheres and 70% carboxymethyl cellulose (CMC) gel carrier, designed to furnish immediate structural support while promoting collagen restoration through various biostimulatory mechanisms. Core technologies of the product consist of the patented ACD-MT® microsphere structure along with the PCD-ETT® gel technology, promising a balance of stability and gradual biodegradability.

Notably, the CaHA microspheres, designed with an average diameter of 30–35 micrometers, feature a raspberry-shaped porous architecture that aids in tissue integration and collagen regeneration. With a G' value of around 5500 Pa, the formulation offers stable injection properties and a measured degradation process. Furthermore, the composition is free from residual chemical cross-linking agents and metabolizes safely within the body, ensuring long-term tissue compatibility.

In China's premium medical aesthetics market, the Aphranel® CaHA filler is categorized as a high-end product, retailing for approximately RMB 12,800 per 0.5 mL syringe. The concept of “The Poetics of Time” has been introduced, aligning with Aphranel's vision of regenerative aesthetics that emphasize gradual improvement and enduring structural outcomes.

In January 2026, Aphranel showcased its offerings at the prestigious IMCAS Paris 2026 congress, further establishing its academic and professional visibility on an international scale.

For Moyom Biotechnology, this EU MDR certification is a significant milestone that supports global advancements in regenerative aesthetic solutions through innovative biomaterials, extensive clinical research, and international collaborations.