09/12/2025
📌Medgate – Your Trusted Local Authorized Representative for Medical Devices in Vietnam
Entering the Vietnamese medical device market can be challenging for foreign manufacturers—especially without a local legal presence. That’s why partnering with an experienced Local Authorized Representative (LAR) is essential for ensuring full compliance and a smooth market entry.
At Medgate, we provide end-to-end regulatory support as your official representative in Vietnam, helping international manufacturers navigate every regulatory requirement with confidence and clarity.
🔹 What Medgate Delivers as Your Local Authorized Representative
As your LAR in Vietnam, we take responsibility for the regulatory lifecycle of your medical device:
✔ Official Representation
We act as your legal representative in all interactions with the Vietnamese regulatory authorities, ensuring your device meets national compliance standards.
✔ Registration & Licensing Support
From preparing technical documentation to submitting registration dossiers, we manage the entire process required to obtain market authorization.
✔ Conformity Assessment Guidance
If your device requires a conformity assessment, our team will advise, coordinate, and support you through each step until approval is secured.
✔ Labeling & Documentation Compliance
We ensure all product labels and related materials meet Vietnamese regulatory requirements and assist with localization when needed.
✔ Post-Market Regulatory Management
Medgate handles reportable events, post-market surveillance, recall coordination, and all mandatory regulatory notifications on your behalf.
✔ Market Access & Distributor Coordination
We provide support in identifying or coordinating with local importers and distributors, helping you enter the market efficiently and compliantly.
✔ Continuous Regulatory Updates
Vietnam’s medical device regulations are evolving — we monitor these changes and keep you informed so your business remains compliant at all times.
🔹 Why Choose Medgate?
Choosing Medgate means gaining a partner who understands the regulatory landscape and prioritizes transparency, reliability, and professionalism.
Our mission is to remove the administrative burden from your path so you can focus on innovation while we handle compliance.
If you are looking for a trusted, knowledgeable, and proactive partner to support your medical device’s journey into Vietnam, Medgate is here to help.
📩 Contact our experts today to get started.
☎️ Hotline: 0895 461 894
🌐 Website: medgate.vn