Medical Device Licensing Vietnam: 2026 Market Guide

Medical device licensing Vietnam requires a product-specific regulatory map covering classification, owner and authorization, circulation, import, establishment conditions, labeling, advertising, vigilance and post-market controls. A certificate from another country or an importer’s business registration is not, by itself, permission to place every device on the Vietnamese market. The dossier and supply chain must match the product actually sold.

This guide uses Decree No. 98/2021/ND-CP on medical-device management as amended, including Decrees No. 07/2023/ND-CP, No. 96/2023/ND-CP and No. 04/2025/ND-CP, together with the 2025 decentralization and administrative-procedure changes identified by the Ministry of Health. Each filing should be checked against the official procedure and authority effective on its submission date.

A medical-device approval is credible only when classification, intended use, technical evidence, manufacturer, authorization, label and post-market controls describe the same product. Regulatory strategy should preserve that identity across application, import, distribution, advertising and vigilance instead of treating licensing as an isolated document submission.

Jurion & Partners healthcare regulatory principle

Medical device licensing Vietnam: define the product

The regulatory file should identify commercial and model names, variants, manufacturer, manufacturing site, intended purpose, indications, users, patient population, principle of operation, accessories, software, packaging and sterilization. Marketing language should not expand beyond the supported intended use.

Product families or grouped applications need a defensible common basis. Differences in intended purpose, risk, technology or manufacturer may require separate treatment. A convenience bundle for sales does not automatically form one regulatory device family.

Medical-device licensing map

Issue	Evidence	Regulatory output
Identity	Model list, intended use and manufacturer	Defined device and variants
Risk	Classification rule and rationale	Supported device class
Market route	Class, origin and current procedure	Applicable declaration or circulation file
Supply chain	Authorization, importer and distributor	Responsible legal entities
Post-market	Complaint, vigilance and recall process	Lifecycle compliance system

Classify using the intended purpose

Classification determines the regulatory route and evidence burden. The analysis should apply current rules to the manufacturer’s intended purpose, invasiveness, duration, energy, measurement, sterility and other relevant characteristics. It should identify the controlling rule and resolve conflicts among possible classifications.

Medical device licensing Vietnam teams should not select a lower class because a foreign market uses a different system. Software, accessories, kits and combination products require careful characterization. Keep the signed classification result and technical rationale with the dossier.

Identify the correct market-access route

The route can differ by risk class, product status, origin and current transitional or special provisions. Determine whether a standards declaration, circulation registration, import route or another procedure applies. The result should name the authority, submission portal, statutory dossier and market activity permitted.

A medical device licensing Vietnam roadmap should distinguish circulation approval from the establishment’s eligibility to manufacture, trade or import. Product and establishment obligations should be sequenced together but not treated as the same licence.

Check authority after decentralization

Healthcare procedures were affected by decentralization measures in 2025, including Decree No. 148/2025/ND-CP. The filing team should use the Ministry of Health’s current published procedure and confirm whether a central or delegated authority receives and decides the specific application.

Confirm the applicant and authorization

The Vietnamese applicant or registration holder must satisfy the applicable legal status, authorization, quality and responsibility requirements. Manufacturer letters, product-owner authorization, warranty responsibility and distribution arrangements should use consistent legal names, registered addresses, manufacturing sites, product models, scope and effective duration across the complete file.

If the manufacturer, owner or applicant changes, determine whether amendment, reauthorization or a new procedure is required before supply continues. Private contract language cannot transfer a regulatory role without completing the official process.

Build the technical dossier

The technical file should explain design, operation, materials, performance, essential safety, standards, risk management, manufacturing, verification, validation and clinical evidence as relevant to the device. Evidence should support the exact models and intended purpose in Vietnam.

Medical device licensing Vietnam review should reconcile certificates, free-sale documents, quality-system evidence, test reports, labels and catalogues. Expired certificates, inconsistent manufacturer sites and unsupported model lists should be corrected before filing rather than explained after an authority query.

Control foreign-issued documents

Documents may require authentication, consular legalization or an applicable exemption, and certified Vietnamese translation. The legal team should verify the current rule for each document type and issuing country. Begin early enough to manage validity periods.

Translations should preserve intended use, manufacturer, model, certificate scope and regulatory status. A translation cannot enlarge a certificate. Keep the original, authentication chain, translated version and document index under version control.

Prepare Vietnamese labeling

Labels and instructions should meet applicable Vietnamese requirements and remain consistent with the classified and approved device. The responsible entity, product and model, manufacturer, warnings, storage, batch or serial information, sterile status and intended-use claims should be reviewed against the technical dossier before release.

Supplementary labels must not obscure mandatory original information or create a contradictory claim. Packaging changes should enter regulatory change control before commercial release. Electronic instructions or software screens may also require review where they communicate regulated use.

Coordinate import and customs evidence

Importer, product description, model, code, quantity, manufacturer and approval status should align across contract, invoice, packing list, customs declaration and regulatory records. The supply agreement should allocate document delivery, inspection support, storage conditions, damaged stock, traceability and recall cooperation throughout the distribution chain.

Medical device licensing Vietnam planning should not promise an import timeline without confirming current customs, product and special-route requirements. Demonstration, research, aid, repair or personal-use shipments may have different conditions and should not be presented as ordinary commercial circulation.

Verify establishment conditions

Manufacturing, trading and technical service activities may require personnel, premises, equipment, quality and declaration conditions under current law. Map each activity actually performed by each Vietnamese entity, including import, storage, distribution, installation, user training, maintenance, testing, calibration, complaint intake and field correction.

A third-party warehouse or service provider should be assessed and contracted for the relevant conditions. Outsourcing does not remove the responsible entity’s duty to control product integrity and records. Licence and declaration details should remain current when location or responsible personnel change.

Manage price and commercial disclosures

Current rules may require price-related publication or other commercial information for relevant devices and transactions. The legal team should verify scope and procedure rather than copy a historical template. Published information should match the product and responsible entity.

Distributor agreements should address pricing independence lawfully, invoice, tax, tender support, product claims, training, stock rotation, complaints and recall. Commercial pressure must not produce inaccurate regulatory or procurement documents.

Control advertising and product information

Websites, social posts, brochures, tenders, training and sales scripts should stay within approved intended use and evidence. Claims about diagnosis, accuracy, superiority, safety or clinical outcome need support. Testimonials and comparative claims require legal review.

A medical device licensing Vietnam approval does not validate every advertisement. Create a promotional review process with medical, regulatory and legal approval, source references, version and withdrawal date. Distributors should use only current approved materials.

Plan post-market vigilance

The registration holder, manufacturer, importer and distributors need a coordinated complaint and incident process. Define intake, medical and technical assessment, reporting, field action, customer communication and authority contact. Product traceability should allow affected lots or serial numbers to be located.

Service and maintenance records can reveal safety patterns. Complaints should not be closed merely because user error is suspected. Investigation should test device, instructions, training, environment and foreseeable misuse, then record the decision and corrective action.

Prepare recall and field action

A recall plan should identify decision authority, risk assessment, affected products, customer locations, authority communications, quarantine, return, correction, disposal and effectiveness checks. Contracts must require distributors, warehouses and service providers to cooperate promptly, preserve traceability and report completion using consistent records.

Medical device licensing Vietnam recall decisions should use current reporting and authority requirements. The company should not delay safety action while commercial responsibility is negotiated. Cost allocation can be resolved separately under contract.

Use regulatory change control

Changes to intended use, model, design, software, material, manufacturer, site, sterilization, label, owner or applicant may affect the approval. The change board should classify regulatory impact before implementation and record whether notification, amendment or new filing is required.

Software updates need particular care. A cybersecurity patch, algorithm change or new clinical function can have different risk. Version, validation, deployment, rollback and customer communication should be controlled and linked to the registered product.

Manage renewals and validity

The licence register should record product, number, status, applicant, manufacturer, models, dates, reporting and change history. Renewal or continuation analysis should begin early enough to obtain foreign documents and complete corrective work under the rules then in force.

Do not assume a transitional extension applies to every device. Confirm the exact provision, product and activity. Customers and distributors should receive accurate status information supported by official records.

• Freeze the intended use and model list.
• Document the current classification rationale.
• Confirm applicant, authority and market route.
• Reconcile technical and foreign certificates.
• Approve Vietnamese labels and instructions.
• Verify importer, trader and service conditions.
• Establish complaint, vigilance and recall controls.
• Screen every product or supply-chain change.

Prepare for inspection

Inspection readiness should cover approvals, classification, quality documents, labels, import and sales records, price or commercial disclosures, promotional materials, complaint handling, technical service, corrective actions and recalls. Evidence should be accurate, current and retrievable from normal operations rather than recreated after an official request.

Decree No. 217/2025/ND-CP is relevant to specialized inspection responsibilities described by the Ministry of Health. The company should verify the authority and scope of any request, cooperate lawfully and retain the material submitted.

Questions to resolve before submission

The final readiness meeting should close the product, applicant and supply-chain questions most likely to cause a rejection or later compliance gap. Answers should be recorded against current official procedures and the exact dossier version proposed for filing.

Can one foreign certificate cover every model?

Only if the certificate’s holder, manufacturer, scope, models and status genuinely cover them and the Vietnamese grouping rules are satisfied. Similar commercial names are not enough. Prepare a model reconciliation that links each requested device to every supporting technical and foreign record.

Can distribution begin after submission?

A medical device licensing Vietnam submission receipt should not be treated as market authorization. Determine the legal effect of the exact procedure and any valid transition applicable to that device. Commercial contracts, import, advertising and customer delivery should be sequenced against the permission actually available.

What if the manufacturer changes a component?

The manufacturer should provide a controlled change description, risk assessment and updated validation. Regulatory staff must decide whether the change affects intended use, classification, safety, performance, labels, certificates or approval before the modified product enters the Vietnamese supply chain.

Official legal references

The central framework is Decree No. 98/2021/ND-CP as amended by Decrees No. 07/2023/ND-CP, No. 96/2023/ND-CP and No. 04/2025/ND-CP. Decree No. 148/2025/ND-CP addresses health-sector decentralization; Decree No. 217/2025/ND-CP is relevant to specialized inspection; and Circular No. 44/2025/TT-BYT informs current administrative procedures identified by the Ministry of Health.

How Jurion & Partners can assist

Jurion & Partners’ Healthcare & Pharmaceuticals legal services can classify the regulatory route, review applicant and supply-chain roles, prepare or remediate technical and administrative dossiers, review labels and promotion, manage authority questions, and design post-market vigilance, recall and change controls. Related guidance appears in Legal Insights.

To assess a device, Book a Consultation or Contact Jurion & Partners. Medical device licensing Vietnam support is most effective before classification, manufacturer documents and commercial claims diverge.

Conclusion

Medical device licensing Vietnam should create a continuous regulatory identity from intended purpose and classification through technical evidence, authorization, labeling, import and post-market vigilance. A current-law route, controlled dossier and lifecycle change system help the business place devices on the market responsibly and respond to safety or authority concerns with reliable evidence.