Vietnam Medical Device Regulations 2026: Circular 24/2026/TT-BYT, Risk Classification, Inspection Deadlines And Compliance Guide

What Vietnam’s Updated Medical Device Requirements Mean for Manufacturers, Importers and Regulatory Teams

Vietnam has updated its medical device regulatory framework through Circular No. 24/2026/TT-BYT, issued by the Ministry of Health on 30 June 2026.

The Circular provides requirements relating to risk classification and management measures for medical devices and amends provisions of Circular No. 05/2022/TT-BYT, which implements aspects of Decree No. 98/2021/ND-CP on medical device management.

One of the most important developments for manufacturers, importers, distributors and healthcare organizations is the updated safe and technical inspection roadmap.

Under the amended implementation provisions:

• Medical devices purchased after 30 June 2027 must undergo the applicable safe and technical inspection in accordance with procedures promulgated by the Minister of Health.
• Medical devices purchased before 1 July 2027 must complete the required inspection before 1 January 2028.
• Circular No. 24/2026/TT-BYT took effect on 1 July 2026.
• Circular No. 59/2025/TT-BYT ceased to be effective from the same date.

For companies supplying medical devices to Vietnam, the update means that regulatory compliance should extend beyond product classification and market authorization to include inspection planning, technical documentation, purchasing dates, product identification and post-market compliance.

Why Vietnam’s Medical Device Regulatory Update Matters

Vietnam has established a risk-based framework for managing medical devices, with regulatory requirements linked to the classification and characteristics of the device.

The regulatory framework is particularly relevant to:

• Medical device manufacturers
• Overseas medical device manufacturers
• Importers
• Distributors
• Authorized representatives
• Healthcare institutions
• Medical device service providers
• Regulatory affairs teams
• Quality and compliance teams
• Procurement organizations

Circular No. 24/2026/TT-BYT continues to operate within the broader framework established by Decree No. 98/2021/ND-CP, as subsequently amended, including by Decree No. 07/2023/ND-CP and Decree No. 04/2025/ND-CP.

The practical impact is that companies should review their Vietnam portfolios not only from a registration perspective but also from an inspection, classification, import and lifecycle-management perspective.

What Has Vietnam Changed?

Circular No. 24/2026/TT-BYT addresses risk classification and management measures applicable to medical equipment and modifies several provisions of Circular No. 05/2022/TT-BYT.

The updated framework should be considered together with Vietnam's wider medical device regulatory structure.

Key areas to review include:

• Medical device risk classification
• Regulatory management measures
• Product documentation
• Safe and technical inspection
• Inspection timelines
• HS code requirements
• Import and export documentation
• Product registration and notification
• Technical documentation
• Post-market compliance

Companies should therefore avoid treating the Circular as a standalone regulatory requirement.

Vietnam Medical Device Compliance: Key Changes briefly

The inspection roadmap is expressly set out in the amended Article 8 of Circular No. 05/2022/TT-BYT.

1. Medical Device Risk Classification

Risk classification remains a fundamental part of Vietnam's medical device regulatory system.

Companies should ensure that each device has an appropriate classification supported by the applicable regulatory criteria and technical documentation.

Depending on the device and applicable requirements, regulatory teams may need to review:

• Intended purpose
• Indications for use
• Duration of use
• Invasiveness
• Active or non-active characteristics
• Implantable characteristics
• Patient-contact characteristics
• Software functionality
• Clinical or diagnostic function
• Applicable classification rules
• Supporting technical documentation

Vietnam's medical device framework continues to use risk categories such as Class A, B, C and D, with increasing regulatory controls as the risk level increases. The Ministry of Health's medical device portal also publicly records classification results for devices.

2. Deadlines You Should Not Overlook Inspection

The revised inspection roadmap is one of the most important practical considerations under Circular No. 24/2026/TT-BYT.

1. Devices purchased after 30 June 2027

Medical equipment covered by the relevant provisions and purchased after 30 June 2027 must undergo safe and technical inspection in accordance with inspection procedures promulgated by the Minister of Health.

2. Devices purchased before 1 July 2027

Medical equipment covered by the relevant provisions and purchased before 1 July 2027 must complete the required safety and technical inspection before 1 January 2028.

This creates an important transition period for companies managing existing installed equipment.

Medical Device Inspection Timeline in Vietnam

Companies should not wait until the end of 2027 to begin reviewing installed equipment.

3. HS Code Requirements Remain Important

Medical device companies should also review the relationship between product identification and customs documentation.

Circular No. 24/2026/TT-BYT specifies that HS codes applicable to medical equipment are those prescribed in Circular No. 19/2024/TT-BYT, which establishes the relevant list of imported and exported medical equipment and commodity codes under Vietnam's nomenclature.

For importers, this means that product information should be consistent across:

• Regulatory submissions
• Product descriptions
• Commercial invoices
• Customs declarations
• HS codes
• Technical documentation
• Product labels
• Import documentation

Inconsistent product descriptions or classification information can create unnecessary regulatory and customs questions.

4. A Regulatory Transition to Note

Circular No. 24/2026/TT-BYT became effective on 1 July 2026.

At the same time, Circular No. 59/2025/TT-BYT ceased to be effective.

Companies maintaining regulatory SOPs, regulatory intelligence databases, product registration files or internal compliance checklists should therefore review references to the previous Circular.

This is particularly important for multinational organizations where global regulatory procedures may continue to reference superseded Vietnamese requirements.

Who Should Pay Attention?

The Ministry of Health continues to publish regulatory decisions and administrative information concerning medical devices, including inspection procedures and device-related regulatory actions.

Product Portfolio and Documentation Review

Companies should conduct a structured review of their Vietnam medical device portfolio.

The assessment should consider:

• Product classification
• Product registration status
• Applicable management measures
• Technical documentation
• Product identification
• Purchase date
• Inspection status
• Inspection certificates or records
• Import documentation
• HS codes
• Labels and instructions for use
• Local representative information
• Post-market records

This is particularly important for organizations managing large portfolios across multiple hospitals, distributors or import channels.

Supply Chain and Procurement Controls

The inspection requirements also create a need for stronger coordination between regulatory affairs, quality, procurement and supply-chain teams.

Companies should consider maintaining a centralized record containing:

• Device name
• Model number
• Manufacturer
• Product classification
• Serial number
• Purchase date
• Import date
• Installation date
• Inspection status
• Inspection due date
• Inspection documentation
• Supplier information
• Regulatory status

A centralized database can make it easier to identify equipment approaching an inspection deadline.

Impact on Medical Device Manufacturers

Manufacturers supplying Vietnam may need to:

• Review device classification
• Confirm intended use
• Update technical documentation
• Review product specifications
• Assess inspection applicability
• Support local regulatory representatives
• Verify product and HS code information
• Review labeling and product descriptions
• Maintain inspection-related documentation
• Monitor changes to Vietnamese medical device requirements

For overseas manufacturers, regulatory responsibility should not be viewed as ending when the product receives market authorization or is imported.

The company should maintain an ongoing Vietnam medical device compliance lifecycle.

Impact on Importers and Distributors

Importers should establish controls covering:

• Product identification
• Manufacturer information
• Regulatory classification
• Purchase date
• Import date
• HS code
• Inspection status
• Technical documentation
• Supplier declarations
• Inspection records
• Distribution records

Attention should be given to equipment already purchased or installed before 1 July 2027, because the applicable inspection must be completed before 1 January 2028.

Existing Medical Devices and Transition Planning

Companies should avoid treating the new requirements as applicable only to newly launched products.

Existing equipment may also require assessment depending on its purchase date and whether it falls within the applicable inspection provisions.

A practical review should identify:

1. Existing installed equipment

Determine which devices are currently operating in Vietnam.

2. Purchase date

Establish whether equipment was purchased before or after the relevant transition date.

3. Inspection status

Determine whether required inspection has already been completed.

4. Documentation

verify that inspection and technical records are available.

5. Deadline

For applicable equipment purchased before 1 July 2027, plan completion before 1 January 2028.

Frequently Asked Questions

1. What is Circular No. 24/2026/TT-BYT?

Circular No. 24/2026/TT-BYT is a Vietnamese Ministry of Health Circular concerning risk classification and management measures applicable to medical equipment and amendments to Circular No. 05/2022/TT-BYT under the medical device management framework.

2. When did Circular 24/2026/TT-BYT take effect?

The Circular took effect on 1 July 2026.

3. What happened to Circular 59/2025/TT-BYT?

Circular No. 59/2025/TT-BYT ceased to be effective when Circular No. 24/2026/TT-BYT entered into force on 1 July 2026.

4. What happens to medical devices purchased after 30 June 2027?

Applicable medical equipment purchased after 30 June 2027 must undergo safe and technical inspection in accordance with procedures promulgated by the Minister of Health.

5. What about medical devices purchased before 1 July 2027?

Applicable medical equipment purchased before 1 July 2027 must complete the required safe and technical inspection before 1 January 2028.

6. Are HS codes changing under Circular 24/2026?

Circular No. 24/2026/TT-BYT specifies that medical equipment HS codes are governed by Circular No. 19/2024/TT-BYT. Companies should therefore verify that regulatory and customs product information remains consistent.

7. Does the update affect overseas manufacturers?

Yes. Overseas manufacturers supplying medical devices to Vietnam should evaluate how the updated Vietnamese requirements affect their products, importers, authorized representatives, technical documentation and inspection obligations.

8. Should existing medical devices be reassessed?

Yes. Companies should review existing equipment, particularly purchase dates, inspection status, technical documentation and applicable regulatory requirements.

9. Does this replace Vietnam's entire medical device regulatory framework?

No. Circular No. 24/2026/TT-BYT modifies specific aspects of the existing framework. Companies should continue assessing requirements under the broader Decree No. 98/2021/ND-CP framework and its amendments and implementing regulations.

Conclusion

Vietnam's 2026 medical device regulatory update introduces important changes for manufacturers, importers, distributors and healthcare organizations.

The implementation of Circular No. 24/2026/TT-BYT reinforces the importance of risk-based device management while establishing a clearer roadmap for safe and technical inspection of applicable medical equipment.

The key dates companies should keep on their compliance calendars are:

• 1 July 2026 — Circular No. 24/2026/TT-BYT becomes effective.
• 30 June 2027 — Key purchase-date threshold for the updated inspection roadmap.
• 1 January 2028 — Deadline for applicable equipment purchased before 1 July 2027 to complete the required inspection.

For companies supplying medical devices in Vietnam, now is the appropriate time to review risk classification, regulatory documentation, inspection status, purchase dates, HS codes and post-market compliance processes.

A proactive compliance strategy can help organizations identify regulatory gaps, prepare inspection schedules and maintain uninterrupted access to the Vietnamese medical device market.

How Maven Regulatory Solutions Can Help

Maven Regulatory Solutions can support medical device companies with:

• Vietnam medical device regulatory assessments
• Circular 24/2026/TT-BYT compliance reviews
• Medical device risk classification assessments
• Vietnam regulatory gap assessments
• Inspection-readiness assessments
• Medical device inspection planning
• Technical documentation reviews
• Product registration and notification support
• HS code and product classification reviews
• Import compliance assessments
• Supplier and distributor compliance assessments
• Regulatory intelligence
• Post-market compliance support
• Product lifecycle management
• Vietnam market-entry strategy

Our approach helps manufacturers, importers and distributors understand changing Vietnamese medical device requirements and develop practical compliance strategies aligned with their product portfolios.