Kossel has achieved another milestone in its global expansion: multiple products have obtained market‑access approvals for Indonesia, Singapore and Vietnam. Notably, four product registrations were granted in Indonesia in a single batch, building a comprehensive product portfolio for the ASEAN market and representing a key breakthrough in the company’s Southeast‑Asia internationalization strategy.
Expanding Footprint with Multi‑product Wins across ASEAN
Four Kossel devices — Falspeed® PTA Balloon Dilatation Catheter, Sabelly® NC PTA Balloon Dilatation Catheter, Falexpand® HP PTA Balloon Dilatation Catheter and MiSatin® Hydrophilic Guidewire — have secured medical device registrations from Indonesia’s Ministry of Health for commercial sale in Indonesia.
This is not an isolated market win, but a matrix‑style roll‑out in Indonesia. The portfolio covers compliant, non‑compliant and high‑pressure balloons, complemented by hydrophilic guidewires, delivering a more complete solution for interventional procedures.
Meanwhile, the Falspeed® PTA Balloon Dilatation Catheter has obtained registration approval in Singapore; the Selepump® Inflation Device has completed registration filing in Vietnam.
With approvals secured in Indonesia, Singapore and Vietnam, Kossel has moved beyond single‑country presence toward broad‑based market access. Its overseas product portfolio now spans balloons, guidewires and inflation devices, creating a synergistic multi‑country, multi‑product presence across ASEAN.
Deepening Southeast‑Asia Engagement: Another Step Forward for Global Strategy
Southeast Asia constitutes a key pillar of Kossel’s global roadmap. The company has previously established manufacturing hubs in Europe and Southeast Asia. The recent wave of Indonesian, Singaporean and Vietnamese registrations embodies its “Local Base, Global Reach” strategy for the ASEAN region.
Favorable regulatory developments support Chinese medical‑device exports to ASEAN. The reliance‑pathway scheme is permanently established in Malaysia and Singapore; mutual‑recognition pilot programs have been launched with Thailand. Such mechanisms can substantially shorten registration timelines for Malaysia. Vietnam’s revised Law on Product Quality, effective 1 January 2026, adopts risk‑based classification management with stricter risk stratification and traceability requirements. Indonesia continues to refine graded medical device registration rules and Bahasa Indonesia labelling compliance requirements. Capitalizing on these opportunities. Capitalizing on these opportunities, Kossel pursues global competition by delivering solid product value, robust quality management systems and full regulatory compliance.
Kossel will keep advancing its global layout by strengthening overseas registration and commercialization capabilities across priority markets including Asia, Europe and Latin America. The company will accelerate commercial roll‑out in Southeast Asia and bring high‑quality Chinese‑origin vascular interventional devices to more hospitals and patients, helping raise standards for vascular‑disease diagnosis and treatment in the region.