Medical Device Import to Vietnam: Why Shipments Get Held at Customs Despite Approval (2026)

Introduction

Many companies assume that once a medical device has been granted a marketing authorization number, the process of medical device import to Vietnam can begin immediately. In reality, things are not that straightforward. A large number of shipments are still held at customs, even when the product has already been “approved.” The issue usually lies in the gap between regulatory paperwork and actual shipping documents. Without proper preparation, delays can stretch from a few days to several weeks. This article walks you through where things typically go wrong and how to get your shipments cleared smoothly.

A marketing authorization is not the same as import approval

This is one of the most common misunderstandings among foreign manufacturers. A granted registration number only confirms that your medical device is allowed to be marketed in Vietnam, in line with Decree 98/2021/ND-CP.

However, that’s only part of the process. When your shipment arrives, the importer still needs to go through customs declaration and inspection. If you rely solely on the registration approval and overlook the import procedures, your shipment can still be held.

Put simply, a registration number allows your product to exist in the market—but it does not guarantee it can pass through customs without issues.

When Goods Arrive at Port: What Customs Inspects

At the port of entry, customs officers don’t just glance at your approval documents. They carefully compare your shipment against the registered dossier.

They will verify whether the declared medical device classification (Class A, B, C, or D) is correct. Product labels and Instructions for Use (IFU) must match what was submitted in the approved dossier. Missing Vietnamese labeling or inconsistencies in content can trigger a hold.

They will also check whether the importing entity matches the authorized representative on record. Commercial documents such as the invoice and packing list must reflect the exact product name as registered. Even minor discrepancies can slow things down significantly.

Common reasons shipments get held at customs

In practice, most delays are not caused by missing documents, but by small inconsistencies that are easy to overlook.

For instance, the product name on the invoice may differ slightly from the one listed in the approved catalog. In other cases, the HS code is declared incorrectly, leading to a mismatch in classification. Missing or incomplete Vietnamese labeling is another frequent issue.

There are also situations where the importer listed in the shipment documents does not match the authorized entity in the registration file. Or the registered product specification differs from what is actually shipped—such as a different model, configuration, or concentration.

These issues may seem minor, but they are enough for customs to pause the clearance process for further verification.

The Gap Between Legal and Operational Regulations – The Root Cause

If you look closely, you’ll see that much of the problem doesn’t lie in regulations, but in the coordination between the parties involved.

Typically, businesses hire a consulting firm to handle the legal paperwork. After obtaining the registration number, transportation is then handed over to a logistics company. These two parties often work independently, and there’s no one responsible for connecting the information.

As a result, the shipping company doesn’t fully understand the registered documents, and the legal team doesn’t have control over the actual documentation. This disconnect is the reason why the paperwork and goods don’t match.

Meanwhile, importing medical equipment requires an understanding of both regulations and customs procedures. A single missing link can affect the entire process.

How to prepare properly before shipment

The most effective way to avoid delays is to review everything carefully before the goods are shipped. This step is often underestimated but makes a critical difference.

Start by checking that the product name is consistent across all documents. Then review the labeling and IFU to ensure they meet local requirements, especially in terms of language and mandatory content.

Make sure the HS code is correctly determined based on the device classification. You should also prepare supporting documents that prove the importer’s eligibility, in case they are requested.

One important but often overlooked step is conducting a pre-alert document check. By reviewing the full document set in advance, you can catch and fix issues before the shipment arrives—rather than dealing with them under pressure at the port.

When everything is synchronized, the benefits are immediately apparent.

When the import process is well-prepared, customs clearance will be faster and less risky. Goods won’t be held at the port, and businesses won’t have to pay additional warehousing or storage costs.

More importantly, on-time delivery helps maintain credibility with partners and customers. In the medical equipment sector, this directly impacts the operations of hospitals and clinics, which always need a stable supply.

In other words, thorough preparation not only helps you get through customs easily, but also ensures the entire supply chain runs smoothly.

Conclusion

Medical device import to Vietnam is not just about obtaining a registration number. Without proper preparation, shipments can still be held at customs, leading to significant additional costs. When businesses fully understand the process and proactively review everything from the start, customs clearance becomes much smoother. If you are planning a medical device import to Vietnam, take the time to carefully check all documents and paperwork now. Doing it right from the beginning will help you avoid many problems later.