Vietnam Issues New Medical Device Classification Guidance to Support Procurement (2026)

Vietnam’s Ministry of Health has introduced an important regulatory development for medical devices with the issuance of Circular No. 57/2025/TT-BYT on 31 December 2025. This guidance provides a structured classification framework for medical devices in the context of procurement, clarifying how devices should be grouped based on technical standards and quality requirements. The new rules will take effect on 15 February 2026, with classification requirements applying from 1 January 2027.

This guidance aims to enable healthcare institutions and procurement entities to more easily identify appropriate device categories that align with clinical needs, technical specifications, and financial capacity. By introducing six distinct device groups from basic to highly specialised products Vietnam’s new classification system enhances transparency and consistency in procurement decisions.

Overview of Circular 57/2025/TT-BYT

Under the new framework, the Ministry of Health defines classification criteria based on technical standards and quality indicators established under Vietnamese law. Key elements of this approach include:

• Technical standards compliance determined through conformity assessments performed in accordance with Vietnamese standards and technical regulations;

• Recognition of conformity results from internationally recognised conformity assessment bodies;

• Documentation demonstrating compliance provided by the medical device owner.

This structured methodology enables healthcare purchasers to assess devices more systematically, ensuring alignment with clinical and supply chain requirements.

Six Device Groups Based on Technical and Quality Criteria

Devices subject to classification are organised into six categories from Group I through Group VI according to defined technical and quality benchmarks. These benchmarks consider factors such as product complexity, intended use, safety performance, and relevant standards compliance. The grouping system is designed to be flexible, allowing devices manufactured domestically or internationally to participate in procurement if they meet Vietnam’s legal and technical requirements.

The classification framework also recognises devices that are lawfully marketed in Vietnam or other jurisdictions, provided relevant evidence of conformity is supplied. This approach harmonises procurement practices with broader regulatory and commercial realities.

Why This Matters for Industry Stakeholders

Circular No. 57 represents a significant step in Vietnam’s regulatory evolution as it enhances clarity and predictability for market participants. For manufacturers, authorised representatives, distributors, and healthcare procurers, the guidance has several implications:

• Improved procurement transparency: Clear device groupings help streamline purchasing decisions and support consistent evaluation across institutions.

• Stronger alignment with international practice: By recognising conformity assessments from recognised bodies, the framework aids global manufacturers seeking market access.

• Advance preparedness: With the classification effective from 2027, companies have an opportunity to adjust documentation and quality strategies ahead of enforcement.

This guidance complements Vietnam’s broader efforts to refine its medical device regulatory ecosystem, including improvements in standards alignment, post-market surveillance, and quality assurance systems.

Looking Ahead

With Circular 57 entering into force in early 2026 and classification requirements applying from 2027, stakeholders should begin reviewing device portfolios and technical documentation to ensure compliance with the new framework. Early engagement with regulatory authorities, authorised representatives, and procurement bodies will be critical for maintaining smooth market operations and enhancing device availability for healthcare providers in Vietnam.

As Vietnam continues to build out its regulatory infrastructure, this classification guidance provides a clearer, more structured approach to medical device procurement aligning regulatory oversight with clinical needs and market practices.

Source: Vietnam Ministry of Health : Guidelines on Classification of Medical Devices for Procurement (Circular No. 57/2025/TT-BYT), issued 31 December 2025, effective 15 February 2026.