Vietnam Transfers High-Risk Medical Device Evaluation to Specialized Authorities

Vietnam’s Ministry of Health issued “Circular 44/2025/TT-BYT” on November 22, 2025, transferring key administrative powers for medical device registration, import licensing, and post-market surveillance to specialized authorities under the Ministry. Effective immediately, the shift alters the issuance of circulation numbers for Class C and Class D devices and establishes a more responsive, technically focused regulatory process.

For support navigating Vietnam’s updated regulatory requirements, get in touch with Cisema's regulatory experts today.

Objectives of Circular 44/2025/TT-BYT

The reform of Vietnam’s medical device administrative framework is intended to:

Increase efficiency by distributing review and decision-making to specialized agencies, reducing processing times and administrative bottlenecks
Improve transparency through clearer regulatory responsibilities and defined authority lines
Strengthen accountability for technical evaluation and post-market surveillance
Enhance vigilance through more responsive monitoring and enforcement to ensure device safety, quality, and performance
Provide a more predictable compliance environment for foreign manufacturers and importers

By shifting operational responsibilities to specialized agencies, the Ministry reinforces Vietnam’s move toward internationally aligned practices in quality management, post-market surveillance, and regulatory approval.

Expanded Responsibilities Assigned to Delegated Authorities

Circular 44 assigns several core regulatory functions to specialized agencies, particularly the Department of Health Infrastructure and Medical Devices. This transfer changes how stakeholders interact with Vietnam’s regulatory system and introduces new expectations for dossier preparation and compliance management.

Delegated authorities now oversee:

Issuance of circulation numbers for Class C and Class D devices, including dossier evaluation, approval, and administrative processing
Post-market surveillance, such as inspections, audits, and compliance assessments
Suspensions, recalls, and corrective actions when safety or performance concerns arise
Issuance, reissuance, and revocation of import licenses, including import permits, Certificates of Free Sale (CFS), and certificates related to organizations performing inspection and quality assessment
Implementation of updated administrative templates for registration, post-marketing reporting, import management, and compliance documentation — replacing older templates previously issued under Circulars 19/2021/TT-BYT and 10/2023/TT-BYT

For senior regulatory teams, the transition requires updated submission formats and clearer internal procedures to manage interactions with delegated authorities.

Stakeholder Implications of Circular 44/2025/TT-BYT

The redistribution of responsibility affects all participants in Vietnam’s medical device market and introduces new expectations for how regulatory decisions will be made. As delegated agencies assume broader authority, the way companies plan submissions, manage documentation, and respond to compliance inquiries will need to adapt.

Manufacturers and Importers

For foreign manufacturers and importers, the shift in oversight will translate into operational changes across both pre-market and post-market activities.

Companies should expect:

Mandatory adoption of updated administrative templates
Potentially shorter review timelines and new compliance responsibilities depending on the delegated authority
New communication pathways with delegated authorities

These adjustments mean that regulatory teams will need to revise workflows, strengthen dossier preparation practices, and ensure internal alignment with the new oversight structure.

Healthcare Institutions and Patients

As regulatory processes stabilize under the new model, hospitals and clinics can expect more reliable procurement timelines and enhanced vigilance outcomes, supporting safer and more effective device use.

Recommended Actions for Medical Device Businesses Operating in Vietnam

In light of these changes, companies operating in Vietnam should proactively reassess regulatory processes and ensure full alignment with the updated oversight structure.

Key actions include:

Reviewing the Circular to understand the revised oversight framework
Updating all application dossiers using the new templates
Preparing for more active post-market surveillance interactions with delegated authorities
Aligning internal regulatory processes with the new delegation structure
Engaging a local regulatory consultancy, such as Cisema, to navigate evolving requirements and maintain compliance

Taking early action will help prevent delays in medical device registration, import licensing, and vigilance reporting as the new system is implemented.

Maintaining Compliance With Vietnam’s Evolving Medical Device Framework

Vietnam’s move toward delegated oversight marks a fundamental restructuring of how high-risk medical devices are evaluated and monitored. The shift creates a more streamlined system that strengthens regulatory consistency and supports safer, more predictable market operations. As specialized agencies assume broader responsibilities, companies that align their regulatory strategies, documentation, and post-market practices early with the new expectations are well-positioned to succeed.

For support with medical device registration and regulatory planning in Vietnam, contact Cisema’s regulatory experts. Our local office in Vietnam provides on-the-ground expertise to guide companies through evolving regulatory requirements.