Class A Medical Devices: Import Procedures into Vietnam (2025)

Class A Medical Devices are widely used in healthcare settings and are classified as low-risk under Vietnam’s medical device regulations. While the import process is more straightforward than for higher-risk devices, businesses still need to follow specific steps to remain compliant. In this article, we’ll walk you through the full import procedure for Class A Medical Devices into Vietnam in 2025 — from classification and declaration to customs clearance and labelling.

Medical Device Classification in Vietnam – Class A

According to current medical device regulations in Vietnam, all medical devices — including Class A Medical Devices — must be classified by the company itself, not by a third-party organization. This self-classification process applies to both domestic and foreign entities.

Class A devices are considered low-risk and include items like bandages, surgical gloves, manual wheelchairs, and basic thermometers. Although businesses are allowed to classify their own products, they must strictly follow the Ministry of Health’s classification rules and use the official list of device types as a reference.

The classification result is a required part of the dossier when declaring applicable standards before importing Class A Medical Devices into Vietnam. Importers and manufacturers must also take full legal responsibility for the accuracy of their classification.

Declaration of Applicable Standards for Class A Medical Devices

Following the classification step, businesses intending to import Class A Medical Devices into Vietnam must submit a declaration of applicable standards. This requirement is outlined under current Medical Device Regulations in Vietnam, and applies to both local and foreign companies.

The declaration procedure is simpler than the formal medical device registration in Vietnam required for higher-risk classes, yet it remains a mandatory step before products can enter the market. Importers are responsible for compiling and submitting a complete dossier to the Department of Health in the locality where the company is based.

The dossier typically includes:

• A completed declaration form (in accordance with Circular 05/2022/TT-BYT)

• The device’s classification result, confirming it belongs to Class A

• Product documentation such as user manuals and instructions for use

• A valid Certificate of Free Sale (CFS) or equivalent document from the manufacturing country

• Certification of compliance with a recognized quality management system (e.g., ISO 13485)

• A Letter of Authorization or Power of Attorney issued by the manufacturer or brand owner, assigning rights to the importer or authorized representative in Vietnam
• A document confirming the warranty policy of the product, or a statement that the product is not subject to warranty

Once the declaration is submitted, importers may proceed with customs clearance and distribution. As Class A devices are regulated under a post-market surveillance mechanism, official approval is not required at this stage — though submitted documents must be ready for inspection if requested by the authorities.

Customs Clearance Procedure for Class A Medical Devices

Once the declaration of applicable standards has been submitted, importers can proceed with customs clearance in Vietnam for their Class A Medical Devices. Customs authorities require a complete and consistent set of documents to verify the legitimacy of the shipment and ensure compliance with current Medical Device Regulations in Vietnam.

The typical customs dossier includes:

• A completed customs declaration form

• Classification Result – Class A
• Receipt of Declaration of Applied Standards – Class A

• Commercial invoice issued by the exporter

• Packing list detailing the contents of the shipment

• Bill of lading or airway bill, depending on the mode of transport

• Sale contract
• Certificate of Origin (if applicable)

It is important that the product information — including name, model, and classification — remains consistent across all documents. Any discrepancies may lead to clearance delays or further inspection by customs officials.

To facilitate a smoother process, businesses should also ensure that the Vietnamese importer’s name is clearly indicated on all import-related documents, and that product labeling complies with local requirements before the shipment arrives at the port of entry.

Need Assistance?

Navigating Vietnam’s medical device import procedures can be complex — even for low-risk items like Class A Medical Devices. Whether you’re handling your first shipment or scaling operations, Green NRJ provides professional, tailored services to help you:

• Classify and document your products

• Prepare and submit regulatory dossiers

• Communicate with local health authorities

• Handle customs documentation and logistics

• Ensure compliance with labelling and post-market obligations

📩 Contact Green NRJ today to simplify your import process and stay compliant with the latest regulations in 2025.