On 30 June 2026, the Ministry of Science and Technology issued Circular 36/2026/TT-BKHCN, specifying the list of products and goods with medium and high risks under the management of the Ministry of Science and Technology (MOST), together with their corresponding HS codes aligned with Vietnam’s List of Exported and Imported Goods and applicable quality management requirements.
Read the full circular here: English translation is not available.
Purpose of the Circular
To specify the list of products and goods with medium and high risks under the management responsibility of the Ministry of Science and Technology.
To provide corresponding HS codes and applicable quality management requirements for listed products and goods.
Scope of Application
This Circular applies to medium- and high-risk products and goods under the management of MOST.
It is also relevant to manufacturers, importers, distributors, and stakeholders handling products subject to conformity assessment, quality inspection, and applicable national technical regulations in Vietnam.
Key Highlights
List of Products and Goods with High and Medium Risk Levels
The Circular establishes:
- Appendix I: List of high-risk products and goods
- Appendix II: List of medium-risk products and goods
- Applicable conformity assessment and quality management requirements for each product category
For high-risk products and goods, testing results serving as the basis for conformity certification must be obtained from a testing organization that is accredited, designated by MOST, or recognized in accordance with the law on standards and technical regulations and the law on product and goods quality, with a testing scope appropriate to the relevant national technical regulation.
For medium-risk products and goods, testing results serving as the basis for self-assessment or conformity certification must be obtained from a testing organization that is accredited, designated by MOST, or recognized in accordance with the law on standards and technical regulations and the law on product and goods quality, with a testing scope appropriate to the relevant national technical regulation.
The recognition of test results is carried out in accordance with the provisions of the law on standards and technical regulations.
Management Principles
Listed products must comply with applicable requirements on product quality, standards and technical regulations, including requirements for conformity certification, conformity declaration, quality inspections, and relevant national technical regulations (QCVNs).
Listed products subject to multiple QCVNs must comply with all applicable regulations. However, duplication of conformity assessment for the same technical requirement that has already been assessed under the corresponding national technical regulations should be avoided.
Where a national technical regulation issued before the effective date of this Circular contains provisions on quality management requirements that differ from those applicable to products and goods listed under this Circular, the provisions of this Circular shall prevail.
Where a national technical regulation is newly issued, amended, supplemented, or replaced for a national technical regulation specified in the list of medium- or high-risk products and goods, or where a new national technical regulation is issued for supplementary application to products and goods listed under this Circular, the provisions of the document issuing such national technical regulation shall apply from its effective date.
Products and goods categorized as medium- or high-risk in the field of atomic energy, including radioactive materials, nuclear equipment, and radiation-emitting devices, shall be managed in accordance with the applicable laws on atomic energy.
Transitional Provisions
Conformity Certificates and Notices of Receipt of Conformity Declarations issued shall remain valid until the expiry dates.
Pending conformity certification applications submitted before 1 July 2026 shall continue to be processed in accordance with the regulations applicable at the time of submission.
Existing designated conformity assessment bodies may continue their operations until the expiration of their respective designation decisions.
During the period in which the National Single Window Portal is being adjusted and upgraded to comply with this Circular, importers shall register for state inspection of imported goods quality through the National Public Service Portal or in accordance with the guidance of the relevant inspection agency.
Applications for the designation of conformity assessment bodies received before 1 July 2026 but not yet fully processed shall continue to be processed in accordance with the laws applicable at the time of receipt.
Products Relevant to the Medical Device Sector
Several product groups commonly used in the healthcare sector are affected, including:
- Medical devices incorporating wireless communication technology, such as Wi-Fi, Bluetooth, RFID, LPWAN, and 4G/5G modules
- Radiation-emitting medical equipment, such as X-ray, CT scanners, and radiotherapy equipment
- Electrically powered medical equipment
Implications to Clients
Clients should review their medical device portfolios to determine whether their products are included in the list attached to this Circular and, where applicable, ensure compliance with the corresponding quality management requirements.
Manufacturers, importers, and distributors should also assess applicable HS codes, conformity assessment requirements, quality inspection obligations, and relevant QCVNs before importing or placing affected products on the Vietnamese market.
Effective Date
1 July 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Vietnam, please contact sales@andamanmed.com.