Many foreign manufacturers believe that once the medical device registration number is granted, the product can be shipped to Vietnam immediately.
In reality, registration approval and import licensing are two different regulatory steps under Nghị định 98/2021/NĐ-CP.
If this stage is not prepared correctly, shipments are delayed at customs even though the device is already “approved”.
Registration number ≠ Permission to import
After receiving the circulation/registration number, the importer must still:
- Declare the shipment under the correct device classification (A/B/C/D)
- Present compliant labels and IFU matching the approved dossier
- Ensure the importer is eligible to import medical devices
- Align invoice, packing list, and product name exactly with the approved documents
Any mismatch here leads to customs holding the shipment.
Why many shipments are stopped at customs
Common real cases:
- Product name on invoice different from the approved catalog
- HS code declared incorrectly for the device class
- Label missing required Vietnamese information
- Importer not matching the Authorized Representative records
- Registration dossier says one dosage/form, shipment shows another
Customs officers check against the approved registration dossier.
The missing link between Regulatory and Logistics
This is where most foreign manufacturers face problems:
The regulatory consultant finishes the registration.
The logistics company handles the shipment.
No one connects the two.
Import licensing for medical devices requires understanding both the approved dossier and customs practice.
What proper import license preparation includes
Before shipment, a proper review should be done:
- Re-check product name vs. registration approval
- Re-check label and IFU consistency
- Verify HS code according to device classification
- Prepare importer eligibility documents
- Pre-alert customs documentation before goods arrive
This prevents clearance delays of 7–30 days.
The practical outcome
When import licensing is synchronized with registration approval:
- Shipments clear customs smoothly
- No storage fees at port/airport
- Distributors receive goods on time
- Hospitals and clinics are supplied without interruption
Need support for import licensing after registration?
If you already have a registration number and are preparing to ship devices to Vietnam, proper import license and customs preparation is critical.
Lucas Do – Vietnam Regulatory & Logistics Consultant
WhatsApp | Zalo | WeChat: +84 0988.281.467
Email: sondx@airseaglobal.com.vn
You can also read the complete guide here:
Medical Device Registration in Vietnam for Foreign Manufacturers