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What procedures are required to import Class B medical devices into Vietnam in 2026 to avoid customs seizure? This is a question many businesses face when entering this potentially lucrative but increasingly regulated market. In this article, Green NRJ will accompany you, analyzing the entire process from classification and declaration of applicable standards to business conditions, helping you understand and implement it correctly from the start.
Understanding Class B Medical Devices According to Current Regulations
According to regulations on medical device classification in Vietnam, Class B medical devices are classified as low to medium risk, determined based on their intended use and the extent of their impact on users. Classification is not based on common sense but must adhere to specific classification rules related to usage duration, degree of bodily penetration, and the biological effects of the device.
In practice, Class B devices typically include products used for short or temporary periods, which may come into contact with the human body but do not pose a high risk if used correctly. Some common examples include blood pressure monitors, nebulizers, surgical gloves, infusion sets, or some common dental instruments.
According to current regulations, businesses registering products for circulation in Vietnam are responsible for classifying their own devices. The classification results must be based on the criteria in Circular 05/2022/TT-BYT and the business is legally responsible. In practice, errors at this stage are a common reason for applications being requested for correction or rejected, as the regulatory authority may re-examine the suitability of the classification during the application processing or post-market surveillance.
Declaration of Applicable Standards: A Mandatory Step Before Importing
For a Class B medical device to be legally imported, businesses must complete the procedure of declaring the applicable standards. This is considered the formal product registration according to current regulations.
This process begins with preparing the documentation. A complete set of documents must not only contain the correct components but also ensure the legal validity of each document.
| 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)
After completing the application, businesses submit it online through the Ministry of Health’s public service portal. Upon approval, the system will issue a standard declaration number. This number acts as a “passport” for the product to be legally imported and circulated in Vietnam.
Customs clearance: no longer requiring a separate license, but don’t be complacent.
Once the declaration acceptance number is issued, businesses can proceed with customs clearance for Class B medical devices without needing to apply for an additional import license. This is an advantage that significantly shortens processing time.
However, complacency should be avoided. In reality, customs authorities still conduct thorough document checks, especially regarding consistency between documents. Discrepancies in information such as product name, product code, model, etc., between the invoice, declaration dossier, and related documents can easily lead to the shipment being detained for further inspection.
To ensure a smooth customs clearance process, businesses need to prepare a complete set of required documents and carefully review them before the goods arrive. In addition, in some cases, customs authorities may request additional documents for verification purposes.
In reality, many shipments are delayed not because of missing documents, but because of discrepancies between the data in the documents. Common examples include different product names between the invoice and the declaration file, or incorrect model information. Although these are minor details, they can significantly impact the customs clearance process.
Therefore, checking and standardizing documents from the outset is crucial. Thorough preparation will help businesses minimize problems during customs clearance, avoiding the need for corrections and additions after the goods arrive at the port, which wastes time and increases unnecessary costs.
Labeling Requirements: Small Details, Big Impact
Labeling is one of the mandatory requirements for imported medical devices before they can be allowed to circulate in the Vietnamese market. If the original label does not fully display the content in Vietnamese, businesses must add a supplementary label in accordance with current regulations.
According to regulations, the content on medical device labels must include all important information such as:
- Name of the medical device
- Name and address of the organization responsible for the product
- Origin of the goods
- Registration number or import license number
- Production batch number
- Production date and expiration 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. Incomplete or inaccurate labeling can directly affect the product’s marketability.
Conditions for Trading Class B Medical Devices in Vietnam
Importing is only the first step. For Class B medical devices to be legally circulated, businesses need to meet the prescribed business conditions. Businesses must be legally established, have a business line related to medical devices, and have appropriately qualified personnel. They must also have a storage facility that meets the required storage conditions.
Furthermore, businesses are required to obtain a certificate of eligibility to trade Class B medical devices before distributing products to the market. This is a crucial but often overlooked condition.
In addition, businesses need to establish and maintain internal processes such as quality management, complaint handling, and product recall procedures in case of risks. These requirements aim to ensure that medical devices are strictly controlled throughout their lifecycle.
Conclusion: Proactive Compliance for Efficient Import of Class B Medical Devices
Importing Class B medical devices into Vietnam in 2026 requires businesses not only to understand the process but also to correctly and completely implement each step, from classification and declaration of applicable standards to meeting business conditions. By preparing well from the outset, businesses will minimize risks and take advantage of opportunities from a rapidly developing market.
Green NRJ is ready to accompany you throughout the entire process, from classification consultation and document completion to legal support and establishing operations in Vietnam. If you need a fast, correct, and safe implementation, please contact Green NRJ for detailed support.
