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Cost & ⏳ Time to Register Class B Medical Devices with the Vietnam MOH
💰 Registration Cost (Approximate)
1. Government Fee
Class B devices are registered through a notification system (no technical review), and currently no official MOH fee is charged for submitting the notification via the MOH portal.
✅ Government fee: 0 VND (as of Decree 07/2023/ND-CP, subject to updates)
2. Other Possible Costs
| Item | Estimated Cost | Notes |
|---|---|---|
| Document legalization (FSC, LOA, etc.) | $100–300 per document | Depends on country of origin and embassy fees |
| Translation (Vietnamese) | $50–150 per document | Required for labels, IFU, technical specs |
| Authorized Representative service | $500–2,000+ per device | Varies by provider, may include full application handling |
| Classification certificate (optional) | $100–300 | Issued by a Vietnamese classification organization |
💡 You can reduce costs if you handle classification and translation in-house.
⏳ Registration Timeline
| Step | Estimated Time |
|---|---|
| Document preparation & legalization | 2–4 weeks |
| Online submission & approval (Class B) | 5–10 working days |
| Total estimated time | 3–6 weeks, depending on preparation speed and document completeness |
⚠️ If your documents are incomplete or need corrections, this could delay the process.
✅ Summary
| Item | Estimate |
|---|---|
| Official MOH Fee | 0 VND |
| Total Cost (including AR, translations, legalization) | ~$1,000–3,000 USD per device (varies) |
| Timeframe | 3–6 weeks from start to approval |
Would you like help estimating the exact cost for your product or want help finding a reliable authorized representative in Vietnam?
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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