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Importing Class A medical devices into Vietnam is currently considered relatively easy compared to higher-risk equipment categories. However, “easy” doesn’t mean it can be done carelessly. Businesses still need to follow each step correctly, from classification and product registration to customs clearance and product labeling. If done correctly from the start, the import process will run much more smoothly. This article will help you visualize the entire process in the easiest and most practical way possible.
What Are Class A Medical Devices and How Are They Classified Under Vietnamese Regulations?
Under the current regulatory system in Vietnam, Class A medical devices are considered the lowest-risk category. These are usually simple, widely used products like bandages, medical gloves, basic thermometers, or manual wheelchairs.
One thing that often surprises newcomers is that businesses can classify their own products instead of going through an authority from the start. That said, this doesn’t mean the process can be taken lightly. Companies are still expected to follow the Ministry of Health’s guidance and check their products carefully against the official classification rules.
In practice, the classification result is more than just a formality. It becomes part of the required documents when submitting the declaration of applicable standards. If the classification turns out to be incorrect, it can lead to problems later on—either during inspections or when handling import procedures.
Declaration of Applicable Standards for Class A Medical Devices: A Required Step Before Import
Once the classification is completed, businesses need to submit a declaration of applicable standards for Class A medical devices before moving forward with importation. This step is mandatory, even though it is not the same as a formal marketing authorization.
In simple terms, this declaration is a way for the company to confirm that its product meets the required technical and quality standards. After the dossier is submitted and accepted, the authority will issue a receipt number, which allows the business to proceed with the next steps.
One practical advantage is that this declaration does not expire, as long as there are no changes to the product. This means companies don’t have to repeat the process for future shipments of the same item.
When it comes to documentation, businesses need to prepare a complete set of supporting documents. In most cases, this includes:
| No. | Document | Requirement | Remarks |
| 1 | Declaration Form (Ministry of Health‘s template) | Signed and stamped by the company; color scanned copy | Prepared by Green NRJ based on information provided by the Client |
| 2 | Certificate of Free Sale (CFS) | Consular legalized; color scanned copy | Provided by the Client |
| 3 | ISO 13485 Certificate | Color scanned copy | Provided by the Client |
| 4 | Letter of Authorization (LOA) issued by the medical device owner authorizing the registrant | According to MOH template; consular legalized | After the Client provides CFS, ISO, and the list of products to be registered, Green NRJ will prepare the LOA template for the Client to obtain from the manufacturer |
| 5 | Warranty Eligibility Confirmation issued by the medical device owner (except for single-use devices as declared by the owner) | According to MOH template; consular legalized | After the Client provides CFS, ISO, and the product list, Green NRJ will prepare the warranty confirmation template for the Client to obtain from the manufacturer |
| 6 | Technical Summary of the medical device in Vietnamese For in vitro diagnostic reagents, calibrators, and control materials: Technical documentation in Vietnamese, together with supporting documents on raw materials, product safety, manufacturing processes, product quality control, and clinical and pre-clinical study reports, including stability study reports. | – Technical summary: According to MOH template, signed and stamped by the company; color scanned copy – Manufacturer’s documents: Original scanned copy + notarized Vietnamese translation | Green NRJ will provide parallel support, consultation, and review with the Client prior to signing and stamping |
| 7 | Product catalogue issued by the medical device owner | Color scanned copy | Provided by the Client |
| 8 | Declared Applicable Standards (DOC) or Certificate of Conformity (CE) | Color scanned copy | Provided by the Client |
| 9 | Instructions for Use (IFU) | Original English version issued by the manufacturer + Vietnamese translation; signed and stamped by the company | The Client provides the manufacturer’s IFU; Green NRJ will consult and prepare the Vietnamese IFU in parallel for the Client prior to signing and stamping |
| 10 | Product labels to be used in Vietnam (original label + secondary Vietnamese label) | Signed and stamped by the company; color scanned copy | The Client provides the original labels; Green NRJ will prepare the Vietnamese secondary label and send it to the Client for signing and stamping |
Source: Adapted from Green NRJ. For more details, see the original article: Vietnam Medical Device Registration Guide (2026)
In reality, documents issued overseas are often the most time-consuming to prepare. Papers like the Certificate of Free Sale or the Letter of Authorization usually need to go through legalization and be translated into Vietnamese before they are accepted.
If anything is missing or not properly prepared, the dossier can easily be rejected, which may delay the entire import process.
Import and Customs Clearance Procedures for Class A Medical Devices: Things Businesses Need to Note
After submitting the declaration of applicable standards and receiving the receipt number, businesses can proceed with customs clearance for Class A medical devices without needing to apply for additional import licenses.
However, it shouldn’t be assumed that everything will be completely simple. Customs still thoroughly checks the documents, especially the consistency between the papers. Product names, codes, models, etc., that don’t match across documents are easily subject to retention for further inspection.
To ensure a smooth customs clearance process, businesses need to prepare a complete set of documents.
Furthermore, in some cases, customs may request additional relevant documents for verification. In fact, many shipments are delayed not because of missing documents, but because of discrepancies between the documents. For example, the product name differs between the invoice and the declaration file, or there may be a model error. Such minor errors can significantly impact the customs clearance process.
That’s why it’s a good idea to review all documents carefully before the shipment arrives. Thorough preparation from the start will help avoid having to make corrections or additions once the goods are at the port, saving both time and additional costs.
Product Labelling Requirements
Labeling is a required step before imported medical devices can be placed on the market. If the original label is incomplete in Vietnamese, businesses must add a supplementary label in accordance with regulations.
The label must include the following information:
- Name of the medical device
- Name and address of the responsible organization
- Origin of the goods
- Registration number or import license number
- Batch number
- Manufacturing date and expiry date
- Instructions for use and storage conditions
- Warnings and safety precautions
This information must be presented clearly, legibly, and without causing misunderstanding for the user. In practice, quite a few shipments run into trouble not because of import procedures, but simply due to labeling issues. That’s why it’s worth taking the time to get the label right from the beginning, instead of having to fix it later when the goods have already arrived.
Key Things to Keep in Mind When Importing Class A Medical Devices in 2026
Despite being classified as low-risk, Class A medical devices are still subject to strict post-import oversight. This means businesses must always be prepared to provide documentation when requested by authorities. In addition, legal regulations in Vietnam may change periodically. Timely updating of new decrees and circulars will help businesses avoid unnecessary risks during the import and distribution process. Collaborating with a professional consulting firm is also a worthwhile option, especially for businesses that are just starting out or lack experience in this field.
Conclusion: Proactive Compliance for Efficient Import of Class A Medical Devices
Importing Class A medical devices into Vietnam will not be too difficult if businesses understand the process and prepare the necessary documents from the start. From classification, standard declaration, customs procedures to labeling, each step needs to be done correctly and consistently to avoid risks. In reality, most problems do not lie in complex regulations, but rather in small errors in documentation or a lack of experience in handling them. Therefore, to save time and minimize risks, businesses should consider using professional support services.
Green NRJ is currently partnering with many businesses in the process of importing medical devices, from consulting on classification and preparing documents to working with relevant authorities. If you need a clear, quick, and compliant solution, do not hesitate to contact Green NRJ for support tailored to your needs.
