On January 23, 2026, the Vietnamese Government issued Decree No. 37/2026/ND-CP, detailing provisions and measures for the implementation of the Law on Product and Goods Quality. The Decree establishes a comprehensive regulatory framework consisting of 8 chapters and 99 articles governing the quality management of products and goods circulating in Vietnam, with a strong emphasis on the application of digital technologies for traceability and data management.
Read the full Decree here [PDF]
Purpose of the Decree
The Decree aims to:
- Establish a unified and comprehensive framework for product and goods quality management in Vietnam
- Promote the adoption of digital technologies to enhance traceability, transparency, and data management
- Strengthen regulatory oversight across the product lifecycle, from production to distribution
Scope of Application
This Decree applies to:
- Products and goods circulating in Vietnam
- Organizations and individuals engaged in production, importation, distribution, and trading of goods
Key Highlights
1. Application of Technology in Quality Management
The Decree promotes the development and use of technology platforms in managing product and goods quality.
Organizations and individuals engaged in production and business are encouraged to apply digital technologies for data collection, storage, and sharing, including:
- Barcodes (1D and 2D)
- QR codes
- Data matrix codes
- Radio Frequency Identification (RFID)
- Near-Field Communication (NFC)
- Other suitable technologies
Priority is given to integrating artificial intelligence (AI), big data, and the Internet of Things (IoT) across the supply chain to enhance data management and traceability.
2. Barcodes and Numbering Systems for Traceability
The Decree encourages the use of barcodes and numbering systems in quality management and product traceability.
Businesses may adopt technologies such as:
- Blockchain
- IoT
- AI
- Other emerging technologies
The selection of systems is left to the discretion of organizations, based on their operational needs.
3. Digital Product Passports and Electronic Labels
- Minimum Content of a Digital Product Passport:
- Product name, Global Trade Item Number (GTIN);
- Name, address, and identification number of the organization or individual producing, importing, or trading the product;
- Information on the product’s origin or the location of the final processing stage;
- Product traceability information;
- Conformity certificates, quality certificates (if any);
- Production date, expiration date (if any);
- Safety warnings (if any);
- Other information for product quality management as required by state management agencies.
- Requirements for a Digital Product Passport:
- Must be in electronic format and linked to a unique identification code;
- The declared information must be truthful, complete, and up-to-date;
- Must ensure the accessibility and connectivity of the traceability database with the National Product and Goods Traceability Portal.
- Organizations and individuals producing and trading products may use the digital passport of their products as a substitute for electronic labels if the digital passport of the product contains all the mandatory labeling information required on electronic labels as stipulated in the Decree.
- Mandatory Content of Electronic Product Labels:
- Low-risk goods: electronic labels are required to display all the mandatory information applicable to each product category.
- Medium or high-risk goods: electronic labels are required to display the following information:
- Name of the goods
- Name and address of the organization or individual responsible for the goods
- Origin of the goods
- Warning information
- Other mandatory information that may be displayed on an electronic label.
- Other requirements: electronic labels must be retained for a minimum of 12 months from the product’s expiration date. Where no expiry date is specified, the retention period shall be calculated and determined by the entity implementing the electronic label.
- Implementation: electronic labels must be declared on the national electronic labeling system at https://elabel.gov.vn. Alternatively, self-declared is permitted, provided data is connected and synchronized with the national database
4. Product Labelling Requirements:
- Original labels must include:
- Name of the goods;
- Origin of the goods;
- Name and address of the organization or individual responsible for the goods:
- If the label does not fully display the name and address of the manufacturer or the organization or individual responsible for the goods overseas, this information must be completely provided in the documents accompanying the goods or in the shipment documentation.
- For goods imported into Vietnam that bear original labels in foreign languages as specified above, the importing organization or individual is required to add labels in Vietnamese in accordance with regulations before distributing the goods in the market
- Supplementary label in Vietnamese (for Medical Devices):
Mandatory information includes:- Registration number or import license number;
- Lot number or serial number;
- Date of manufacture & expiration date:
- For sterile, single-use medical devices, reagents, calibration materials, control materials, and chemicals, the expiration date must be indicated.
- In other cases, the manufacturing date or expiration date must be indicated;
- For machinery or equipment, the year of manufacture or month and year of manufacture must be indicated
- Information on Warning, Instructions for Use (IFU), Storage Instructions, and Warranty may be shown directly on the medical device label or clearly indicated on the label with instructions for accessing this information.
Implication to Clients
Clients should review and update their goods quality management systems. They are advised to adopt modern management tools to enhance compliance and operational efficiency. In addition, clients should closely monitor labelling regulations within Vietnam’s regulatory framework to ensure full compliance when circulating goods.
Effective Date
The Decree takes effect on January 23, 2026. Several existing regulations will be repealed upon its entry into force.
- Regulations Repealed from July 01, 2026:
- Decree 132/2007/ND-CP, dated December 31, 2028, detailing the implementation of several articles of the Law on Product and Goods Quality and Article 2 of Decree No. 67/2009/ND-CP dated August 2, 2009, detailing the implementation of several articles of the Law on Product and Goods Quality
- Decree No. 74/2018/ND-CP, dated May 15, 2018, detailing the implementation of several articles of the Law on Product and Goods Quality
- Article 4 of Decree No. 154/2018/ND-CP, dated November 9, 2018, detailing the amendment, supplementation, and repeal of certain regulations on investment and business conditions in the field of state management under the Ministry of Science and Technology and certain regulations on specialized inspections
- Decree No. 13/2022/ND-CP, dated January 21, 2022, detailing the implementation of several articles of the Law on Product and Goods Quality, and Decree No. 86/2012/ND-CP, dated October 19, 2012, detailing and guiding the implementation of several articles of the Law on Measurement.
- Regulations Repealed Upon Entry into Force:
- Clauses 3 to 7, Article 1 of Decree No. 13/2022/ND-CP, dated January 21, 2022, detailing the implementation of several articles of the Law on Product and Goods Quality; and Decree No. 86/2012/ND-CP, dated October 19, 2012, detailing and guiding the implementation of several articles of the Law on Measurement
- Decree No. 43/2017/ND-CP, dated April 14, 2017, on product labeling
- Decree No. 111/2021/ND-CP, dated December 9, 2021, detailing the amendment and supplementation of several articles of Government Decree No. 43/2017/ND-CP dated April 14, 2017, on product labeling.
- Transitional Provisions
- Goods bearing labels that comply with the regulations of Decree No. 43/2017/ND-CP and Decree No. 111/2021/ND-CP, which were produced, imported, circulated, or used before the effective date of this Decree, may continue to be circulated and used until the expiration date indicated on the product label.
- Labels and packaging produced and printed before the effective date of this Decree may continue to be used, but not for more than two years from the effective date of this Decree.
- The classification of products and goods into Group 1 and Group 2, and the application of management measures for products and goods in Group 1 and Group 2, shall continue to be implemented according to the regulations specified in Clause 2 of this Article until 30 June 2026
For Inquiries
For inquiries or support regarding product and goods regulatory requirements in Vietnam, please contact sales@andamanmed.com.
