从卫生部注册到医院采购目录，MedBridge 以悉尼—胡志明市双实体运营，为中国器械厂商提供一条完整、可控、直达终端的越南市场通路。
注册自主可控——上市许可持有权不被经销商绑架
医院渠道直达——不止拿证，更进入私立医院采购
From Ministry of Health registration to hospital procurement lists — MedBridge runs on-the-ground operations in Sydney and Ho Chi Minh City, giving device manufacturers one controlled pathway to the Vietnamese market.
Own your registration — market authorisation never held hostage by a distributor
Beyond licensing — direct access to private hospital procurement
数据口径：行业公开报告与主管部门数据；正式上线前逐条标注来源。Figures from public industry and government reporting; itemised sources to be cited before launch.
认知前提
注册、经销、医院准入是三层完全不同的能力。MedBridge 把三个 Access 做在同一个团队里。
The premise
Registration, distribution and hospital access are three different capabilities. MedBridge builds all three inside one team.
分类界定 · 注册申报 · 证件持有权控制
Classification · registration · certificate control
进口清关 · 仓储物流 · 经销体系与价盘
Import · warehousing · distribution and pricing
科室演示 · 采购对接 · 医院供应商准入
Clinical demos · procurement · supplier onboarding
准入通路
依据越南《医疗器械管理法令》（Nghị định 98/2021/NĐ-CP）框架，按产品风险分类规划最短合规路径。
The pathway
Structured under Vietnam's medical device framework (Decree 98/2021/NĐ-CP), with the shortest compliant route mapped to your device's risk class.
按 A/B/C/D 风险分类确定申报或注册路径，编制技术文档，向卫生部及地方主管部门提交并跟进。
Determine the declaration or registration route by A/B/C/D risk class, compile technical files, submit and follow up with MOH and local authorities.
进口许可、标签合规、清关与仓储，胡志明市自有仓配体系承接首批货物落地。
Import licensing, labelling compliance, customs clearance and warehousing through our own Ho Chi Minh City facilities.
匹配区域经销商，设计价盘与商务条款，注册证持有权留在您可控的主体名下。
Regional distributor matching, pricing and commercial terms — with the registration certificate held by an entity you control.
依托集团私立医院合作网络，安排科室演示与采购部门对接，进入医院供应商体系。
Department demonstrations and procurement introductions through the group's private hospital relationships, entering the hospital supplier system.
服务
多数监管顾问止步于注册证。MedBridge 的服务设计围绕一个问题：设备最终有没有摆进诊室。
Services
Most regulatory consultants stop at the certificate. Every MedBridge service is designed around one question: did the device end up in the consultation room?
Nghị định 98/2021 口径下的分类界定、标准声明（A/B类）与上市注册（C/D类），技术文档编译与审评跟进。
Classification under Decree 98/2021, standards declaration (Class A/B) and marketing registration (Class C/D), technical file compilation and review follow-up.
进口许可与标签合规、清关代理、胡志明市保税与常温仓储，冷链方案按品类配置。
Import licensing, labelling compliance, customs brokerage, bonded and ambient warehousing in Ho Chi Minh City; cold chain configured by category.
南部起步的经销商筛选与谈判、价盘设计、回款条款把关；注册持有与商业分销分离，渠道可换、证不旁落。
Distributor screening and negotiation starting from the south, pricing design, payment term safeguards. Registration holding separated from commercial distribution: channels can change, the certificate stays with you.
集团深耕越南私立医疗体系：与头部私立医院及连锁医疗集团的既有供货关系、VPHA（越南私立医疗协会）会员网络、临床专家顾问资源，帮助设备直达科室演示与采购流程。
Built on the group's standing in Vietnam's private healthcare system: active supply relationships with leading private hospitals and hospital groups, VPHA membership network, and clinical advisor resources — taking devices straight to department demos and procurement.
服务品类
全品类均可评估；以下类目具备成熟准入路径，妇幼与生殖类为当前重点切口。
Who we serve
All categories assessed; the following have established pathways. Women's and children's health is our current priority wedge.
妇产 · 新生儿 · 辅助生殖（IVF）设备与耗材
OBGYN · neonatal · assisted reproduction (IVF)
CT · MRI · DR · 超声
CT · MRI · DR · ultrasound
监护仪 · 心电 · ICU 设备
Monitors · ECG · ICU equipment
诊断试剂 · POCT · 实验室设备
Diagnostics · POCT · lab equipment
手术室 · 麻醉 · 医用耗材
Operating room · anaesthesia · consumables
康复设备 · 家用医疗（按渠道另评）
Rehabilitation · home medical (channel assessed separately)
为什么是越南
越南人口过亿、中产快速扩容，私立医院集团处于跑马圈地阶段——新院区、新科室意味着成批的设备采购预算，而约九成器械依赖进口。欧美日设备价格高企，性能达标、价格占优的中国设备正处在最好的替代窗口。
Why Vietnam
A population of 100+ million, a fast-growing middle class, and private hospital groups in land-grab mode: new campuses and new departments mean batch equipment budgets, while roughly ninety percent of devices are imported. With Western and Japanese equipment priced at a premium, capable Chinese devices are in their best substitution window.
FV、Hoan My、Tam Anh、Phuong Chau 等集团持续新建院区，采购决策链短于公立招标，对新供应商更开放。
FV, Hoan My, Tam Anh and Phuong Chau keep building. Procurement chains are shorter than public tenders and more open to new suppliers.
Nghị định 98/2021 与东盟医疗器械指令（AMDD）对齐，分类规则明确，合规路径可以被规划、被承诺。
Decree 98/2021 aligns with the ASEAN Medical Device Directive. Classification rules are explicit — the compliant route can be planned and committed to.
陆海联运周期短、售后半径近，配合本地仓储可承诺的交付与维保，是欧美厂商难以匹敌的服务半径。
Short land-sea transit, a close after-sales radius, and local warehousing enable delivery and maintenance commitments Western manufacturers struggle to match.
医院渠道 · 集团履历
MedBridge 是 AU SUNSHINE International Group 旗下的医疗器械市场准入品牌。集团自 2022 年起在越南实体运营，医疗渠道履历可查可验。
Hospital network · group track record
MedBridge is the medical device market access brand of AU SUNSHINE International Group, operating on the ground in Vietnam since 2022. Our healthcare channel record is verifiable.
集团与胡志明市国际化私立医院及湄公河区域连锁医疗集团保持在履行中的供货协议，覆盖多家院区。
The group holds performing supply agreements with an international private hospital in Ho Chi Minh City and a multi-hospital group in the Mekong region.
澳大利亚背景的越南私立医疗协会会员企业，并为全国私立医疗发展论坛赞助方，直接触达医院决策层。
An Australian-background member of the Vietnam Private Hospital Association and sponsor of the national private healthcare forum, with direct access to hospital leadership.
集团已在越南完成多个健康产品的注册与公告（công bố），熟悉卫生部审评实操与文档口径。
The group has completed multiple health product registrations and công bố notifications in Vietnam, with working knowledge of MOH review practice and documentation standards.
注：以上为集团层面业绩与资质；具体合作方名称与授权范围，可在商务洽谈中提供验证材料。
Note: credentials above are held at group level; counterparty names and scopes of authorisation can be verified during commercial discussions.
法规动态
Regulatory watch
确立 A/B/C/D 四级风险分类与相应的申报/注册双轨路径，A/B 类标准声明制显著快于 C/D 类注册审评。
Establishes A/B/C/D risk classes and the dual declaration/registration track. Class A/B declarations move significantly faster than C/D registration review.
Nghị định 07/2023 起对部分 C/D 类产品设过渡条款，进口许可与注册衔接窗口需逐品类核对，直接影响上市时间表。
Since Decree 07/2023, transitional provisions apply to certain Class C/D devices. Import licence and registration windows must be checked per category — they set your launch date.
越南已将上市后监督（PMS）与全国器械数据库列为监管重点，进入市场的厂商需提前搭建不良事件报告与追溯能力。
Vietnam has prioritised post-market surveillance and a national device database. Entrants should build adverse-event reporting and traceability capability early.
关于我们
About us
MedBridge 隶属于澳大利亚健康产业集团 AU SUNSHINE International Group（ASIG），集团总部位于悉尼，越南运营中心设于胡志明市富润郡，拥有本地运营团队与仓储物流体系。
集团创始人拥有约十二年跨境健康产业运营经验，曾为多家国际药企与健康品牌担任授权经销与市场运营角色，并将澳洲母婴营养品牌从越南实体注册做到品类头部。这套"注册—进口—渠道—终端"的完整打法，如今复用于医疗器械赛道。
我们只做深度服务：每期并行服务的厂商数量有限，确保每个项目由创始团队直接操盘。
MedBridge belongs to AU SUNSHINE International Group (ASIG), an Australian health industry group headquartered in Sydney with its Vietnam operations centre in Phú Nhuận District, Ho Chi Minh City — local team, warehousing and logistics included.
The group's founder brings around twelve years of cross-border health operations, including authorised distribution roles for international pharmaceutical and consumer health companies, and built an Australian maternal nutrition brand from Vietnamese entity registration to a category-leading position. That full registration–import–channel–endpoint playbook now runs on medical devices.
We work in depth: the number of manufacturers served in parallel is capped, so every project is run directly by the founding team.
团队结构
医院关系、临床法规、越南执行、中越商务，四种能力在同一张桌子上。成员介绍与实景照片近期上线。
The team behind your entry
Hospital relationships, clinical and regulatory expertise, Vietnamese execution and China-side commercial design. Profiles and photos coming soon.
私立医院协会与医院管理层资源，负责医院高层对接与准入策略。
Hospital association and executive-level relationships; owns hospital strategy and onboarding.
医疗与法律双背景，负责临床沟通、医院准入合规与法规协调。
Medical and legal expertise; owns clinical engagement and regulatory coordination.
经销商管理、商务谈判、仓储物流与项目跟进的本地执行团队。
Local execution: distributor management, negotiation, logistics and project delivery.
与中国厂商的沟通界面：项目设计、品牌与市场进入战略。
The manufacturer-facing interface: programme design, brand and market entry strategy.
告诉我们你做什么设备，我们告诉你进入越南最短的路。
免费市场准入评估：初判产品分类与注册路径、预估周期与投入、给出渠道切入建议。填写右侧信息，我们将在一个工作日内联系您。
9月22–24日 · 胡志明市西贡会展中心（SECC）。展前预约 1 对 1 洽谈，展位号确认后将同步至本页。
Tell us what device you make. We'll tell you the shortest route into Vietnam.
Free market access assessment: preliminary classification and registration route, estimated timeline and cost, and a channel entry recommendation. We respond within one business day.
22–24 September · SECC, Ho Chi Minh City. Book a pre-show one-on-one; our booth number will be posted here once confirmed.