tradewithviet.com

A Visual Guide to Sourcing Medical Devices in Vietnam

Key insights into a rapidly expanding and highly regulated market.

Market Structure

A Market Defined by Imports

Vietnam’s advanced medical technology segment relies heavily on foreign manufacturing. Over 90% of high-end equipment is sourced from abroad.

>90%[1]

Import Dependency

Compliance

Risk-Based Classification

All devices are classified by risk level, defining the registration process and governing body (Decree 98/2021/ND-CP[2]).

Class A & B (Low / Low-Moderate Risk)
Declaration of Standard (Notification Process)
Provincial DOH (Department of Health)
Class C & D (Moderate-High / High Risk)
Circulation Registration (CSDT Dossier)
National MOH (Ministry of Health)
Origins

Top Sources of Imported Devices[3]

A handful of global leaders dominate, reflecting demand for quality and sophistication.

Local Strength

Domestic Manufacturing Focus

Local firms are strong in consumables and low-risk devices.

  • ⚕️ PPE (Personal Protective Equipment)
  • 🧤 Surgical Gloves
  • 💉 Syringes & Catheters
  • 🔬 Low-complexity Instruments
Public Sector

Key Shifts in Public Procurement[4]

Recent changes promote transparency and cost-efficiency, moving toward flexible and centralized models.

🤝

Price Negotiation

For limited-supplier items, direct negotiation increasingly replaces traditional competitive bidding.

🛒

Centralized Procurement

More items (e.g., stents, lenses) are purchased in bulk nationally to lower costs.

📝

Flexible Quotations

Facilities may contact suppliers directly and, for niche devices, bypass the three-quote rule.

Sources & References

  1. Import Dependency: Global Trade Analysis Report, Q2 2024.
  2. Regulatory Framework: MOH Vietnam, Decree 98/2021/ND-CP.
  3. Import Sources: Vietnam Customs & MPI, 2023.
  4. Public Procurement: MOH Circular 14/2023/TT-BYT; Decree 07/2023/ND-CP.

This infographic provides a high-level overview. Always consult the latest decrees for full compliance.