The Single Most Important Question
Before prices, samples, or lead time, one factor determines legitimacy in Vietnam's market more than any other.
Pronounced (roughly): "So Loo Hahng"
This Circulation Registration Number is a non-negotiable requirement.
The Supplier Litmus Test: A 3-Step Flow
Use this simple Q&A to quickly gauge a supplier's regulatory maturity.
Step 1: The Golden Question
"Can you provide the Số Lưu Hành for this product?"
✓ Good Answer
"Of course. Here is the number. You can verify it on the official DMEC portal."
Indication: Experienced, transparent, compliant.
! Red Flag Answer
"Our distributor handles that."
Indication: Likely middleman or outsourced compliance. Proceed with caution.
✗ Major Red Flag
"It's in process."
Indication: Treat as "No" until a certificate is produced.
Not All Approvals Are Equal
MOH classifies devices from A (lowest risk) to D (highest). Experience with C/D indicates stronger QMS & regulatory depth.
The chart shows the rising regulatory difficulty. Match a supplier's history to your device complexity.
The "Export Only" Caveat
If a factory only exports, they won't have a Số Lưu Hành. Your vetting pivots to international "golden documents."
ISO 13485
Global QMS standard. Verify with issuing body.
CE Marking
Conformity for EEA markets.
FDA Registration
Request registration or 510(k) details.
Advanced Sourcing Shortcuts
Geography tells a story. Use these heuristics to filter partners faster.
Shortcut 1: North vs. South DNA
Clusters differ by capability and commercial style.
Southern Hub (HCMC, Binh Duong)
Strengths: Consumables, plastics, rubber, sterilization; faster commercial cycles.
Mental Shortcut: Need disposables and speed? Go South.
Northern Hub (Hanoi, Haiphong)
Strengths: Electronics, precision assembly, complex devices; proximity to CN supply chain.
Mental Shortcut: Need electronics & engineering? Look North.
Shortcut 2: Industrial Park Litmus Test
Address quality is a strong proxy for compliance and capability.
Major Green Flag ✓
Located in a High-Tech Park (e.g., Saigon Hi-Tech Park, Hoa Lac Hi-Tech Park) or specialized Medical Device Zone.
Why this matters:
- • Pre-vetted: Stricter entry requirements.
- • Infrastructure: Reliable power, logistics, waste treatment.
- • Compliance: Higher labor & environmental standards.
Mental Shortcut: An address can beat a sales pitch.
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