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November 16, 2025
Approximately 5 minutes
Vietnam Medical Device Importing and Customs Clearance: Roles and Common Delays
Vietnam Medical Device Importing and Customs Clearance: Roles and Common Delays
The importing process and customs clearance for medical devices in Vietnam, governed under Decree 98/2021, requires precise coordination and documentation. A key feature of the Vietnamese regulatory landscape is the strict separation of roles between the entity holding the market registration and the entity handling the physical importation.
Key Roles in the Import Process
The import process involves two distinct legal entities: the Market Authorization (MA) License Holder and the Importer.
| Role | Responsibility |
|---|---|
| MA License Holder | Holds the official registration/license for the product in Vietnam. Must issue an authorization letter and provide the product's MA License to the licensed Importer to facilitate customs clearance. |
| Importer | A separate, properly licensed local company responsible for the physical logistics, submission of shipping documents, payment of duties, and clearance of the shipment through customs. |
Required Financial and Shipping Documents
The customs clearance process generally aligns with international standards, requiring the submission of standard shipping documents and payment of applicable taxes:
- Import Tax (Duties): Rates vary based on the product’s Harmonized System (HS) Code. Many medical devices may benefit from 0% import duty.
- Value-Added Tax (VAT): The general VAT rate is 10%; however, for medical devices listed in Circular 30, the rate may be reduced to 5%.
Common Causes of Customs Clearance Delays
Manufacturers should be aware of several common inconsistencies that frequently lead to significant and costly delays at customs:
- HS Code Discrepancies: Inconsistency in the HS Code used across different shipments or by different freight forwarders can raise flags.
- Valuation Inconsistency: Discrepancies between the declared value of the goods and the customs assessment of the shipment's value.
- Shipment Completeness: Customs does not typically allow for partial clearance. A shipment containing a mix of valid and expired items will be held entirely until the issue is resolved.
- Labeling Inconsistencies: Discrepancies between the product label/catalogue number that was originally submitted for registration and the actual physical product label/catalogue number on the imported goods.
Ensuring consistency between the License Holder's documentation and the Importer's shipping documents is paramount for smooth and timely market entry.
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