Dual Certifications Demonstrate Core Technical Strength
Medgen Life Science (Shenzhen) Co., Ltd. has announced that its independently developed Platelet-Rich Plasma (PRP) preparation device has successfully obtained Class C medical device registration in Vietnam. This follows the product's earlier approval under China's NMPA as a Class III medical device.
This milestone marks Medgen's PRP preparation device gaining official market access in Southeast Asia, opening a new chapter in the internationalization of Chinese regenerative medical technology.
Rigorous Approval Process, High-Standard Recognition
Vietnam implements a strict risk-based classification management system for medical devices, with Class C representing a high-risk category that demands rigorous approval processes and extremely high standards. The successful approval of Medgen's PRP preparation device demonstrates that its safety, efficacy, and quality management systems have met Vietnam's stringent regulatory requirements, aligned with international standards.
Core Product Advantages
The device features an internationally advanced triple-chamber integrated design combined with proprietary processing technology, ensuring PRP concentration stability within the optimal therapeutic range of 4.3x to 6.8x. For product reliability, critical components (such as the locking core) utilize premium materials with dual US FPD and USP certification, providing a 50% improvement in flexibility and ensuring operational safety and stability at the source.
Strategic Southeast Asian Positioning
Medgen's choice of Vietnam as its first Southeast Asian market entry point reflects a clear regional strategy. As a major economy in Southeast Asia, Vietnam's medical device market holds enormous potential, and this approval lays a solid foundation for broader Southeast Asian market expansion.
This represents not only a critical step in Medgen's internationalization strategy but also an important milestone for the Chinese medical device industry going global — driving the entire industry toward higher-end, more standardized, and more internationalized development, and elevating China's position in the global medical device value chain.
Looking ahead, Medgen will continue to leverage its core technology innovations, deepen its presence in regenerative medicine, and advance its global compliance strategy. The company will steadily pursue market access and application of its products and innovative solutions in additional target markets, committed to building an international network spanning R&D, manufacturing, clinical practice, and service — bringing advanced Chinese regenerative medical technologies to the benefit of patients and clinicians worldwide.