Effective from July 1, 2026, Circular No. 24/2026/TT-BYT officially comes into force. The Circular provides regulations on risk classification and management measures for medical devices, while also amending and supplementing several provisions of Circular No. 05/2022/TT-BYT.

For manufacturers, distributors, and especially medical device importers, staying updated with these new regulations is essential to ensure customs compliance and minimize potential risks during the import process.

Below are the key highlights businesses should pay attention to.

1. New Regulations Officially Take Effect on July 1, 2026

One of the most significant updates is that Circular No. 24/2026/TT-BYT becomes effective from July 1, 2026. At the same time, Circular No. 59/2025/TT-BYT is no longer valid from this date.

Businesses importing medical devices after July 1, 2026 should review their current procedures and ensure all documentation complies with the new regulatory requirements.

2. Continued Risk-Based Management of Medical Devices

The Circular reaffirms that medical devices must be classified according to their risk level, with corresponding management measures implemented in accordance with Decree No. 98/2021/ND-CP and its guiding documents.

Proper risk classification helps businesses:

• Apply the appropriate regulatory requirements.

• Prepare compliant documentation.

• Minimize delays during customs clearance.

Companies are advised to carefully review the technical specifications of their products before conducting risk classification.

3. HS Codes Continue to Follow Circular No. 19/2024/TT-BYT

According to Circular No. 24/2026/TT-BYT, HS codes for medical devices shall continue to be applied in accordance with Circular No. 19/2024/TT-BYT, which specifies the HS classification list for imported and exported medical devices.

Accurate HS code declaration is essential for:

• Customs declaration.

• Compliance with specialized management policies.

• Determining import duties.

• Preparing import documentation.

Incorrect HS codes may result in customs declaration amendments, delayed clearance, or additional costs.

4. Updated Roadmap for Medical Device Inspection

The Circular amends Article 8 of Circular No. 05/2022/TT-BYT and introduces a clear inspection timeline for certain medical devices.

Accordingly:

• Medical devices procured after June 30, 2027 must undergo technical performance and safety inspection before being put into use.

• Medical devices procured before July 1, 2027 must complete the required inspection no later than January 1, 2028.

Businesses should proactively incorporate these inspection requirements into their procurement and operational plans.

What Should Businesses Do?

To ensure smooth import procedures after July 1, 2026, businesses should:

• Stay updated with Circular No. 24/2026/TT-BYT.

• Verify the risk classification of medical devices.

• Declare the correct HS codes.

• Monitor the required inspection schedule.

• Prepare complete customs documentation before importation.

Keeping up with these regulatory changes will help businesses reduce compliance risks, save time, and avoid unnecessary costs during the import process.

Songwin – Your Trusted Partner for Medical Device Imports

Songwin provides comprehensive support for businesses importing medical devices, including:

• Consultation on import regulations and specialized management policies.

• Review and verification of import documentation.

• Assistance with HS code classification.

• Fast and compliant customs clearance services.

• Professional support in resolving customs and regulatory issues.

If your business is planning to import medical devices, contact Songwin for reliable and efficient customs and logistics solutions.

SONGWIN INTERNATIONAL LOGISTICS VIETNAM CO., LTD.

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