Maijie Life Sciences Secures Vietnam Class C Certification for PRP Preparation Device, Following D-Class Approval for Bone Graft Material

As a high-tech enterprise deeply engaged in the field of regenerative medicine, the dual certification breakthrough achieved by Medgen Life Sciences this time is no accident.On December 4, 2025, its first globally distributed blockbuster product, "Pre-filled Injectable Bone Filling Material," was the first to obtain Vietnam's Class D medical device registration certificate.

The product has been previouslyIn December 2024, it obtained the Class III Medical Device Registration Certificate from China NMPA (Registration No. 20243132567), being the first domestically produced injectable artificial bone material in China.

Following closely,On January 23, 2026, the Platelet-Rich Plasma (PRP) Preparation Device successfully obtained the Vietnam C-Class Registration Certificate. This product has also received the Class III Medical Device Registration Approval from China's NMPA.

Both products have passed the "China compliance + overseas high-risk certification" dual system, laying a solid foundation for Medgen Life Sciences' global multi-regional market access and becoming a key pivot for unlocking the Southeast Asian regenerative medicine market.

The market breakthrough of Medgen Life Sciences stems from its deep technical accumulation and product innovation capabilities.Medgen Life Sciences, supported by two core technology platforms—"Hydroxyapatite Regeneration Product Transformation" and "Biomedical Collagen Crosslinking Technology"—has built a product matrix covering multiple disciplines including orthopedics, sports medicine, dentistry, and medical aesthetics.Both core products launched overseas have demonstrated significant technological differentiation advantages.

The product's raw material is sourced from natural porcine cancellous bone, retaining the complete natural trabecular bone structure. It provides an excellent carrier for cell attachment and proliferation while accurately simulating the microenvironment of human bone, demonstrating superior osteoinductive properties.Its innovative pre-filled form supports direct injection and filling, with excellent extensibility and arbitrary shaping capabilities, significantly reducing operation time. It has demonstrated osteoinductive effects comparable to autologous bone in large animal spinal fusion experiments. Its performance has surpassed many traditional PLA/PLGA/hydroxyapatite artificial bone products and is suitable for filling and repairing bone defects in limbs and spine under low-load conditions.

The product adopts an internationally advanced three-chamber integrated design, combined with proprietary process column technology, ensuring the prepared PRP concentration remains stably within the ideal therapeutic range of 4.3 to 6.8 times.Key components such as the lock core are made from top-grade materials certified by both American FPD and USP standards, increasing flexibility by 50%. This ensures operational safety and stability from the source, meeting the precise treatment needs of medical aesthetics institutions and specialized hospitals.

Medgen Life Sciences Chooses Vietnam as the First Stop in Southeast Asia Due to Precise Market Analysis and Strategic Considerations. As an Important Economy in Southeast Asia, Vietnam Has a Population of Nearly 100 Million, with Strong Demand for Medical Infrastructure Upgrades and a Continuously Expanding Gap in Medical Devices in Fields Such as Orthopedics and Medical Aesthetics.Data shows that Vietnam performs over 500,000 orthopedic surgeries annually, with the bone filler materials market growing at a rate of over 18%.At the same time, the rapid increase in dental implant penetration provides a broad range of application scenarios for regenerative medical products.

More crucially, Vietnam's medical device market has long been monopolized by Western brands like Johnson & Johnson and Medtronic, with similar products priced prohibitively high, making them unaffordable for grassroots patients.Medgen Life Sciences, with its "common technical origin + cost advantage," is able to fill the gap in the mid-to-high-end orthopedic materials market with injectable bone filler materials, while also meeting diversified precision treatment needs with PRP preparation devices, achieving dual breakthroughs in "technological substitution" and "market penetration."Moreover, using Vietnam as a pivot, it can also radiate to ASEAN countries such as Thailand and Malaysia, accumulating compliance experience and brand trust for subsequent regional expansion.

The dual-certification breakthrough of Medgen Life Sciences is not only a crucial step in its own internationalization strategy but also provides a replicable new path for the high-end globalization of China's medical device industry.Compared with the traditional model of "low-end product exports," Medgen Life Sciences has embarked on an advanced path of "core technology innovation + global compliance layout + localized services."

At the technical level, it relies on independently developed core technologies to break the monopoly of Europe and the United States, forming a differentiated competitive advantage; at the compliance level, it builds a dual system of "China NMPA Class III certification + overseas high-risk certification," laying a solid foundation for global multi-regional access; at the market level, it precisely targets the gaps in overseas mid-to-high-end markets, achieving technological substitution with cost-effective products, and changing the traditional impression of "low-end output" for Chinese medical devices.

This "technology + compliance + market" collaborative model provides valuable reference for more Chinese-produced medical enterprises to go global, driving China's medical device industry to leap from "catching up" to "running neck and neck" and "taking the lead."