From Single Product to Multi-Product Portfolio: Accelerating Global Expansion
Medgen Life Science has announced that its oral bone filling material — PoroGraft® — has successfully passed review by Vietnam's Ministry of Health and obtained Class D medical device registration, the highest risk classification in Vietnam's medical device regulatory system.
This is the third high-end medical device from Medgen to receive approval in Vietnam, following BoneSwift™ injectable bone filling material and the PRP preparation device. This milestone marks the systematic deployment of Medgen's multi-product portfolio in the Southeast Asian market and provides a replicable model for Chinese premium dental devices entering international markets.
Class D Registration: The Most Stringent Approval Standard
Class D registration covers all high-risk products implanted in the human body, requiring rigorous biosafety evaluation, clinical efficacy validation, and GMP quality management system review. This approval not only grants PoroGraft® full market access in Vietnam but also represents international authoritative recognition of China's independently developed oral regenerative material technology, providing global dental patients with additional quality treatment options.
Three Core Advantages
As China's first xenograft bone filling material derived from porcine bone, PoroGraft® leads the oral bone regeneration field with three core advantages:
Natural Biomimetic Structure — Selected porcine cancellous bone retains the natural trabecular three-dimensional interconnected pore architecture, guiding directional bone cell migration.
Superior Osteoconduction — Porosity closely approximates human cancellous bone, promoting rapid vascular and new bone tissue ingrowth to accelerate osseointegration.
Excellent Biocompatibility — Employing rigorous viral inactivation and immunogen removal processes, achieving international-standard biosafety and reducing post-operative rejection risk.
The product is broadly indicated for extraction site preservation, alveolar ridge augmentation, maxillary sinus lift, and peri-implant bone defect repair, meeting the diverse clinical needs of dental implant treatment.
Advancing the Global Strategy
From single-product market entry to multi-product portfolio deployment, Medgen is steadily advancing its global strategic positioning. Using Vietnam as a strategic pivot point, the company is extending its reach to Thailand, Indonesia, the Philippines, and other ASEAN markets, bringing Chinese innovative medical technologies to more international patients. Consecutive approvals through Vietnam's Ministry of Health high-standard review process demonstrate the company's comprehensive capabilities in biomaterial preparation processes, quality control systems, and clinical translation.
Looking ahead, Medgen will continue to uphold its founding mission of "from medicine, for medicine," driving high-quality development through technology innovation and contributing Chinese wisdom and strength to the global field of oral regenerative medicine.