Hunan Endovascular Device Co., Ltd. (EVT Medical) is pleased to announce that its Ureteral Stent product has officially received the Import Medical Device Marketing Authorization (Izin Edar Alat Kesehatan Impor) issued by the Ministry of Health of the Republic of Indonesia (Kemenkes RI). The certification is valid through April 28, 2030.
This milestone marks another key step in EVT Medical’s regulatory compliance strategy for the Southeast Asian market, laying a solid foundation for the company’s deepened expansion in the region.
1. Authoritative Certification Reinforces Product Compliance
The newly approved ureteral stent is classified by the Indonesian Ministry of Health as a Class C Sterile Non-Electromedical Device, under the Gastroenterology-Urology/Surgical Devices category. It is a core consumable for the treatment of urinary stones, ureteral obstruction, and other urological conditions.
Issued directly by the Indonesian Ministry of Health, the marketing authorization covers all product models and carries a five-year validity period. This certification confirms that the product fully meets the strict regulatory requirements for medical devices in Indonesia. It also reflects EVT Medical’s international standard-level quality control and manufacturing systems, providing authoritative assurance for the product’s legal sale, hospital admission, and clinical use in the Indonesian market.
2. Deep Expertise in Urology Builds Global Competitiveness
As a leading domestic supplier of urological interventional consumables, EVT Medical focuses on developing high-reliability, clinically adapted interventional solutions. The newly approved ureteral stent leverages the company’s mature polymer material technology and precision manufacturing processes. It offers excellent biocompatibility, reliable drainage performance, and user-friendly delivery, effectively meeting clinical needs in scenarios such as ureteral obstruction management and post-stone surgery drainage. This allows EVT Medical to deliver high-quality, made-in-China medical device solutions to patients in Indonesia.
3. Accelerating Southeast Asia Expansion to Grow Global Footprint
Indonesia, as the largest economy in Southeast Asia, represents a high-potential market for EVT Medical’s global strategy. Prior to this approval, several of the company’s urological and gastroenterology products have already completed regulatory registrations in Latin America and other Southeast Asian markets. The Indonesian approval for the ureteral stent further strengthens EVT Medical’s regional compliance portfolio.
Moving forward, EVT Medical will continue advancing international registrations for its full line of urological and interventional products, while deepening partnerships with local distributors and healthcare providers. The company remains committed to bringing compliant, high-quality Chinese medical innovations to clinical settings worldwide.
Hunan Endovascular Device Co., Ltd. (EVT Medical)
April 2026
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