On 30 June 2026, the Vietnam Ministry of Health (MoH) issued Circular No. 24/2026/TT-BYT on the determination of risk classifications and management measures for medical device products and goods, and amendments and supplements to certain articles of Circular No. 05/2022/TT-BYT detailing the implementation of several articles of Decree No. 98/2021/NĐ-CP on medical devices.
Read the full circular here: English translation is not available.
Purpose the of Circular
To provide updated requirements on the determination of risk classifications and management measures for medical device products and goods in Vietnam.
To amend and supplement certain provisions under Circular No. 05/2022/TT-BYT, which details the implementation of several articles of Decree No. 98/2021/NĐ-CP on medical device management.
Scope of Application
This Circular applies to medical device products and goods subject to risk classification and management measures in Vietnam.
It is relevant to manufacturers, importers, distributors, and stakeholders involved in placing medical devices on the Vietnamese market.
Key Regulatory Provisions
Risk Classification and Market Management
The determination of risk classification and corresponding management measures for medical devices shall be carried out in accordance with the provisions of Decree No. 98/2021/NĐ-CP and its guiding documents.
Device-specific HS codes must comply with the official import/export nomenclature mandated under Circular No. 19/2024/TT-BYT.
Mandatory Verification Roadmap
The Circular amends Article 8 of Circular No. 05/2022/TT-BYT, which details the implementation of several articles of Decree No. 98/2021/NĐ-CP on medical device management.
Scope of Applicable Medical Devices
The verification roadmap applies to the medical devices listed under Clauses 1, 2, 3, 4, 5, and 6 of Article 5 of Circular No. 05/2022/TT-BYT, including:
- Ventilators
- Anesthesia machines with ventilators
- Electrosurgical units
- Infant incubators
- Defibrillators
- Hemodialysis machines
Verification Timelines
Procurement Timeline | Verification Requirement |
Procurement conducted after 30 June 2027 | Must undergo verification of safety and technical specifications |
Procurement conducted before 1 July 2027 | Must complete verification of safety and technical specifications before 1 January 2028 |
All verification processes must follow the verification procedures issued by the Minister of Health.
Implications to Clients
Manufacturers, importers, and distributors should review their product portfolios in light of Circular No. 19/2024/TT-BYT and be aware of the verification deadlines when entering products into the Vietnamese market.
Clients handling the listed medical device categories should assess whether their products fall within the mandatory verification roadmap and prepare the required safety and technical specification documentation in advance.
Companies should also ensure that HS code classification, risk classification, and market management requirements are reviewed for consistency before importation, procurement, or market placement in Vietnam.
Effective Date
1 July 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Vietnam, please contact sales@andamanmed.com.