Medical Devices

LABELING REQUIREMENTS FOR MEDICAL DEVICES

Medical device labeling is not only a means of product identification but also a legal basis for traceability, regulatory compliance assessment, and ensuring user safety. According to current Vietnamese regulations, all medical devices circulated on the market must bear a label that is properly formatted and contains all required information. In this article, MEDGATE provides an overview of the labeling requirements for medical devices.

Legal Basis

  • Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices

  • Decree No. 111/2021/ND-CP amending and supplementing certain articles of Decree No. 43/2017/ND-CP dated April 14, 2017, on goods labeling

Label Format, Language, and Placement

1. Placement: The label must be placed in a location that is easily visible and clearly displays all required information.

2. Size: Organizations or individuals responsible for labeling may determine the label and font size, provided that:

  • All mandatory information is fully legible;
  • Characters must be large enough to be read with the naked eye;
  • Text, images, and symbols must be clear, and required content must have sufficient contrast with the background.

3. Language: Mandatory content must be in Vietnamese, except in the following cases where Latin-based scripts are allowed:

  • International or scientific names of human-use drugs without Vietnamese equivalents;

  • International/scientific names with chemical/formula structures of ingredients;

  • Component names that cannot be translated meaningfully into Vietnamese;

  • Names and addresses of foreign entities involved in production.

Mandatory Labeling Contents for Medical Devices

As per Clause 1, Article 22 of Decree 98/2021/ND-CP, medical devices must have labels with the following information:

1. Device name: Must be prominently placed and use the largest font size compared to other required information.

2. Name and address of the responsible organization/individual:

  • No abbreviations allowed for names or addresses.
  • For domestically manufactured devices: indicate the manufacturer’s name and address.
  • For imported devices: indicate the manufacturer’s name and address, and the registration holder in Vietnam.

3. Country of origin: Use terms such as “manufactured in,” “made in,” “produced by,” followed by the country or territory name—no abbreviations allowed.

4. Circulation number or import license number

5. Lot or serial number

6. Manufacturing date and expiry date:

  • Sterile, single-use devices, reagents, calibrators, control materials, and chemicals must include expiry dates.
  • Other cases must indicate either manufacturing or expiry date.
  • For machines/equipment: indicate year or month/year of manufacture.

7. Warning information, usage instructions, storage conditions, warranty information: These may appear directly on the label or include instructions on how to access them.

Additional Notes

  • If user manuals and warranty details are not provided with the device, they must be made available electronically, with clear access instructions on the label.

  • Label samples submitted during standard publication or registration must be certified by the responsible organization.

  • Labels for clinical trial devices must include the phrase:
    “Medical device for clinical trial use only – not for other purposes.”

Labeling is not merely a technical task, but a mandatory legal obligation. Businesses must ensure accurate, complete, and clear labeling in compliance with applicable laws to avoid penalties, product recalls, or brand damage.

For more information about medical device registration and obtaining circulation numbers, please contact MEDGATE via Hotline: +84 98 546 1894 or Email: medgatevn@gmail.com for consultation on documentation, procedures, and service quotes.