WEGO's Helios Sirolimus-Eluting Coronary Stent System Receives Vietnam Marketing Authorization, Marking a Milestone for Chinese Cardiovascular Devices in Southeast Asia

Recently, the Department of Infrastructure and Medical Equipment under the Ministry of Health of Vietnam (IMDA) officially issued the Medical Device Registration Certificate, approving Shenzhen Kinhely Bio-Tech Co., Ltd. under WEGO Group (Kinhely Bio-Tech Co.,Ltd.) ofSirolimus Drug-Eluting Coronary Stent System (Sirolimus Coronary Stent Systems）Marketed in Vietnam. This product is classified by the Vietnamese Ministry of Health asHighest Risk LevelDClass (TBYT Loại D）Implantable medical devices, by Purecert Vietnam subsidiary (CÔNG TY TNHH PUREGLOBAL VIỆT NAM) as the registration holder (MAH), providing end-to-end regulatory registration services. This marks another landmark breakthrough for Chinese cardiovascular interventional devices expanding into the Southeast Asian market.

I. About Weigao Group: A Leading Enterprise in China’s Medical Device Industry

Weigao Group (WEGO) established in1988Headquartered in Weihai City, Shandong Province, WEGO is one of China's largest enterprise groups in the medical device and pharmaceutical industries. After more than thirty years of development, WEGO has evolved into a comprehensive conglomerate with diversified business segments covering clinical care, medical consumables, orthopedics, blood purification, interventional devices, and pharmaceuticals.

?Global Layout: Products are sold globally120Operations span multiple countries and regions, with a business presence in the United States, Germany, Japan, Singapore, and other locations.

?R&D Strength: Established a national-level enterprise technology center, with a cumulative total of3000patents, exceeding100Multiple Products Have Broken Foreign Monopolies

?Industry Position: Recipient of national-level honors including the China Industrial Award, the China Charity Award, the Global Excellence in Performance Enterprise award, the National Advanced Model Enterprise for Implementing Excellence in Performance, and two nominations for the China Quality Award.

II. Certified Products:HeliosSirolimus-Eluting Coronary Stent System

The products that have obtained Vietnamese registration certificates this time areHeliosSirolimus-Eluting Coronary Stent System, is one of the core products in the cardiovascular intervention field of WEGO Group.

?Product Overview

?Product Name：Stent mạch vành phủ thuốc Sirolimus(Sirolimus-Eluting Coronary Stent)

?Trade Name：Helios

?Product Classification: VietnamDClass III (Highest Risk) Implantable Medical Devices

?Manufacturer：Kinhely Bio-Tech Co., Ltd.(Shenzhen Kinhely Bio-Tech Co., Ltd.)

?Model Specifications: CoveringJHLDSeries40multiple specifications and models, covering mainstream diameters (2.25mm-4.0mm) and length (10mm-38mm) Combination

?Technical Features

Drug-eluting stent system via femoral artery or radial artery, percutaneous coronary intervention (PCI) implanted into the narrowed segment of human coronary arteries to support the vessel wall and treat coronary stenosis. After the outer surface of the stent closely apposes the vessel wall, the sirolimus coated on its surface (Sirolimus, also known as rapamycin) for sustained drug release, effectively inhibiting vascular smooth muscle cell and intimal hyperplasia, thereby preventing post-procedural restenosis——This is one of the most common complications after coronary stent implantation.

WEGO possesses independent intellectual property rights in the field of drug-eluting stents. Its products utilize titanium oxide coating technology, combining the advantages of biodegradable coatings and sirolimus to achieve revascularization while significantly enhancing biocompatibility, as well as the long-term safety and efficacy of the product.

III. Registration History:DVietnam's Class High-Risk Devices"The Path to Breakthrough"

As the highest-risk medical devices directly implanted into human blood vessels, drug-eluting coronary stents face extremely stringent regulatory scrutiny for market registration in any global market. Vietnam is no exception.——According to Vietnam's "Decree No.98/2021/NĐ-CPDecree No. and the Amending Decree “No.07/2023/NĐ-CPNo.》,DClass II medical devices must undergoMarketing Authorization Registration(Marketing Authorization Registration)Pathway, subject to comprehensive technical review by the central agencies of the Vietnamese Ministry of Health.

?VietnamDKey Points for Class II/III Medical Device Registration

?Review Agency: Department of Infrastructure and Medical Equipment, Ministry of Health of Vietnam (IMDA/Cục Hạ tầng và Thiết bị y tế）

?Regulatory Basis：Decree 98/2021/NĐ-CP + Decree 07/2023/NĐ-CP + Circular 05/2022/TT-BYT + Circular 44/2025/TT-BYT

?Technical File: Based onASEAN CSDT（Common Submission Dossier Template) Framework Compilation

?Registration Requirements: Must be held by a locally registered holder in Vietnam (MAH) Submit the complete registration dossier, includingISO 13485Certificate, Power of Attorney legalized by the Vietnamese Embassy (LoA) and Free Sales Certificate (FSC), technical documents,IFU, labels, clinical evaluation reports, etc.

?Registration Cycle: Official Cycle18-24months (without reference country approval) or12-18months (subject to approval by reference countries); the actual timeline varies depending on product complexity and the status of supplementary submissions

?Of Particular Note: Vietnam since2025Year11Implemented the new “Article” starting from the month44/2025/TT-BYTNo. [Notice], which further refined the tiered management and approval processes for medical device registration. ThisHeliosThe stent’s registration certificate was approved precisely under the new regulatory framework, marking the PureCert Vietnam team’s in-depth understanding of the latest regulations and their mature localized operational capabilities.

IV. Certificate Sharing

V. Why Choose Vietnam? The Strategic High Ground of the Cardiovascular Intervention Market in Southeast Asia

The Vietnamese market holds significant strategic value for companies in the cardiovascular interventional device sector:

?Demographic Dividend: Vietnam's total population exceeds1With a population of over 100 million, it is the third most populous country in Southeast Asia and has a young demographic structure; however, with changing lifestyles, the incidence of cardiovascular diseases continues to rise.

?High Import Dependence: Vietnam’s medical device market is heavily reliant on imports, particularly for high-risk implantable products, with a very low domestic substitution rate; Chinese cost-effective products hold significant competitive advantages.

?Strong Economic Growth: VietnamGDPMaintained for Consecutive Years6%With the above growth rate, healthcare expenditure continues to rise, driving expanding demand for high-end medical devices.

? ASEANRadiation Effects: As a core member of ASEAN, Vietnam offers more than just access to its domestic market through product registration; it also establishes the regulatory foundation for subsequent expansion into other ASEAN member markets.

?Deepening of China-Vietnam Trade: China has been Vietnam's largest trading partner for many consecutive years, with deepening cooperation between the two countries in the healthcare sector and favorable import policies for medical devices.

VI. PureCert Vietnam: Localized Team+End-to-End Service

This time, Weigao GroupHeliosThe successful certification of the drug-eluting stent once again demonstrates the professional expertise of the PureCert Vietnam team in the registration of high-risk implantable medical devices.

?Pure Diagnostics Vietnam (PUREGLOBAL VIETNAM）is a wholly-owned subsidiary established by PureCert in Vietnam, with its headquarters located in Ho Chi Minh City, possessing the qualifications of a complete local Vietnamese regulatory registrant (MAH) qualifications, is an important partner for Chinese medical device companies to enter the Vietnamese market.

Our Core Competencies in Vietnam:

✅Full Risk Level Coverage——FromALow-risk toDClass III highest-risk implants, with proven practical experience in registration

✅ MAHCertified Services——As the locally registered holder in Vietnam, assume full-cycle legal responsibilities for product registration, importation, and post-market surveillance.

✅Local Team——Familiar withIMDAReview Process and Communication with the Vietnamese Ministry of Health to Efficiently Address Technical Reviews and Requests for Supplementary Information

✅ CSDTDocument Preparation——Proficient inASEAN CSDTTechnical Dossier System: Tailored Regulatory Registration Strategies for Enterprises

✅Legalization Process——Assist in completing administrative procedures such as legalization and certification by the Vietnamese Embassy, sworn translation, etc.

✅Post-Market Compliance Management——Including ongoing compliance services such as adverse event reporting, labeling changes, and certificate maintenance

VII. Final Remarks

Coronary drug-eluting stents are in the field of cardiovascular intervention"Crown Jewel", and it is also one of the product categories subject to the most stringent regulatory review in various countries. This time, WEGO GroupHeliosThe successful regulatory approval of the stent in Vietnam is not only a significant milestone in WEGO Group’s internationalization strategy but also a microcosm of Chinese proprietary high-end implants entering the Southeast Asian market.

PureCert will continue to partner with WEGO Group to deepen its presence in Southeast Asia and global markets, helping more innovative Chinese medical devices benefit patients worldwide.?

If you also have needs for exporting high-risk medical devices to Vietnam or other Southeast Asian markets, please feel free to contact us. PureReg will provide you with one-stop services from market access strategy to registration implementation.