Critical Medical Device Labeling Requirements Every Business Must Know (2026)

Medical Device Labeling is one of the mandatory requirements before a product can be placed on the market. However, many businesses still do not fully understand the procedures involved, the mandatory information that must appear on labels, or how labeling should be presented to comply with legal regulations. In this article, Green NRJ provides businesses with a clear overview of the regulations on medical device labeling under Decree No. 98/2021/ND-CP, while also highlighting important considerations to help minimize risks during product circulation.

Legal Basis Currently Applicable to Medical Device Labeling

At present, medical device labeling activities are governed by Decree No. 98/2021/ND-CP on the management of medical devices and Decree No. 111/2021/ND-CP amending and supplementing regulations on goods labeling. These legal documents provide detailed requirements regarding how information must be displayed on labels, the responsibilities of businesses, and the mandatory contents that must be included before products are permitted to circulate in Vietnam. They also serve as the legal basis for authorities to assess product compliance during post-market inspections.

Why Businesses Need to Pay Special Attention to Labeling

In practice, many businesses tend to focus heavily on declaration dossiers or circulation registration procedures while paying insufficient attention to product labeling. However, medical device labels are not only used for product identification but also serve as a key source of information for users and a basis for authorities to verify the legal status of products.

If mandatory information is missing, improperly presented, or displayed in an inappropriate language, businesses may be required to amend their dossiers, face administrative penalties, or even be forced to recall products from the market. Therefore, ensuring compliant labeling from the outset can help businesses avoid unnecessary procedures and prevent disruptions to product circulation.

Regulations on the Presentation of Medical Device Labels

After understanding the importance of product labeling, businesses should also clearly understand the requirements regarding how information must be presented on labels under current regulations.

Labels Must Be Placed in an Easily Visible Position

According to regulations, medical device labels must be positioned where they can be easily recognized with the naked eye. Users must be able to read all necessary information without removing packaging or performing complicated additional steps. This requirement is intended to ensure that important information such as product names, origin, and warning instructions remains clearly accessible during use.

Font Size and Information Must Ensure Readability

Current regulations do not specify fixed dimensions for labels or font sizes. Businesses are free to design labels suitable for their product packaging, provided that all mandatory contents are fully displayed and readable by the naked eye. In reality, some businesses reduce the size of legal information in favor of packaging aesthetics, which may result in information becoming difficult to read or unclear during use.

Colors Used on Labels Must Be Clear and Easily Recognizable

Text, numbers, symbols, and images displayed on labels must be presented clearly and maintain sufficient contrast with the background color. In particular, mandatory information required by law must be displayed in a manner that is easy to recognize and does not create confusion for users.

Regulations on Language Used on Medical Device Labels

In addition to presentation requirements, businesses must also pay attention to the language used on product labels. Under current regulations, mandatory information on medical device labels must be written in Vietnamese. This requirement ensures that domestic users can fully read and understand product-related information. However, certain specialized terms may still be presented in other languages using the Latin alphabet, including:

• International names or scientific names that do not have equivalent meanings in Vietnamese
• Chemical formulas or structural formulas of chemicals or pharmaceutical substances
• Specialized components that are difficult to translate into Vietnamese
• Names and addresses of foreign entities involved in product manufacturing

Using the correct language for each category of information will help businesses avoid errors during declaration and circulation procedures for medical devices.

Mandatory Information Required on Medical Device Labels

After satisfying requirements regarding presentation and language, businesses must ensure that product labels contain all mandatory information prescribed in Clause 1, Article 22 of Decree No. 98/2021/ND-CP.

Medical Device Name

The product name must be displayed in a clearly visible position and in a larger font size than other mandatory contents on the label. This information helps users correctly identify the product and avoid confusion with other medical devices on the market.

Name and Address of the Responsible Organization

For domestically manufactured medical devices, labels must clearly state the name and address of the manufacturing establishment.

For imported products circulated in Vietnam, businesses must provide:

• The name and address of the manufacturer associated with the product’s origin
• The name and address of the holder of the medical device circulation registration number

Under regulations, proper names and geographical names on labels may not be abbreviated.

Product Origin Information

The origin of medical devices may be indicated using phrases such as “manufactured in,” “country of manufacture,” “origin,” or “made in.” These phrases must be followed by the full name of the country or territory where the medical device was manufactured, and country names may not be abbreviated.

Circulation Number or Import License

Medical devices circulated on the market are required to display the circulation number or import license number corresponding to the dossier approved by the competent authority. This serves as proof of the product’s legal status for circulation in Vietnam.

Batch Number or Serial Number

Batch numbers or serial numbers are important for quality management, product traceability, and handling issues that may arise during product use.

Manufacturing Date and Expiry Date

For sterilized medical devices, single-use products, chemicals, reagents, control materials, or calibrators, businesses are required to display expiry dates. For machinery or technical equipment, the manufacturing year or month and year of manufacture may be indicated depending on the type of product.

Instructions for Use and Storage Information

Information relating to instructions for use, safety warnings, storage conditions, or warranty service providers must be fully displayed on labels or accompanied by instructions on how users may access such information. This requirement ensures that users can obtain all necessary information during product use.

Common Issues Businesses Often Overlook When Preparing Medical Device Labels

In addition to mandatory contents, businesses should also pay attention to several requirements relating to dossiers and methods of providing information. In cases where Vietnamese instructions for use or warranty information are not directly included with the product, businesses may provide such information electronically. However, the label must clearly indicate how users can access the information.

In addition, label samples included in dossiers for declaration of applicable standards or circulation registration must bear confirmation from the organization named in the dossier.

For medical devices intended for clinical research, labels are required to clearly display the statement: “Medical device for clinical investigation only. Not to be used for any other purpose.”

Proper Labeling Helps Businesses Facilitate Product Circulation

Medical device labeling is a mandatory requirement when placing products on the market and is also one of the aspects most commonly inspected by authorities during post-market review procedures.

Preparing labels that are complete, clear, and compliant with regulations helps businesses minimize errors, avoid administrative penalties, and prevent disruptions to product circulation activities. If businesses require support in reviewing label contents, preparing declaration dossiers, or consulting on procedures related to medical devices, Green NRJ is ready to accompany and support businesses throughout the implementation process.