Latest Procedures for Obtaining a Medical Device Import License

A Medical Device Import License is no longer required as the default approval for every import shipment. Applying an incorrect regulatory pathway may cause customs delays, increase storage expenses, and interrupt the delivery of medical devices to hospitals and clinics. From 2026, the license mainly applies to six designated categories of medical devices that have not obtained a Marketing Authorization Number. For standard commercial products, enterprises should prioritize securing a Marketing Authorization Number to support compliant importation under the Law on Enterprises and Businesses. Before proceeding with Long Phan Consulting, businesses should verify product classification, the Certificate of Free Sale, ISO 13485 certification, and the Letter of Authorization.

Legal Regulations on Medical Device Import Licenses in 2026

In 2026, a Medical Device Import License is no longer the default regulatory pathway for all commercial import activities. Instead, businesses should shift from the traditional approach of obtaining an import license for each shipment to managing their product portfolio through the Marketing Authorization Number system.

This regulatory change has a direct impact on import planning, distribution negotiations, and customs clearance schedules. For medical devices that have already obtained a Marketing Authorization Number in Vietnam, businesses may import them based on market demand without obtaining prior approval from the Ministry of Health, in accordance with Clause 2, Article 46 of Decree No. 98/2021/ND-CP, as amended and supplemented by Clause 11, Article 1 of Decree No. 07/2023/ND-CP.

The key strategic changes that businesses should manage include:

• The Marketing Authorization Number has become the primary regulatory mechanism governing the importation of commercial medical devices.
• An Import License is now applicable only to specific categories of medical devices that have not yet obtained a Marketing Authorization Number, as prescribed in Clause 1, Article 48 of Decree No. 98/2021/ND-CP, as amended and supplemented by Clause 11, Article 1 of Decree No. 07/2023/ND-CP.
• Product documentation should be thoroughly reviewed before signing an import contract or opening a Letter of Credit (L/C).
• The risk of customs clearance delays increases significantly if businesses continue to rely on expired import licenses or outdated product classification documents.

From a risk management perspective, businesses should immediately divide their product portfolio into two categories: products requiring a Marketing Authorization Number and products eligible for a special-purpose Import License. This approach helps minimize warehousing costs, delivery delays, and potential disputes with distribution partners.

List of medical devices subject to a specific licensing mechanism.

Businesses should only prepare documents for import license applications when the product does not yet have a registration number and falls under the specific purpose. This is the first legal screening point before incurring costs for translation, consular legalization, and technical documentation preparation.

Have 6 cases Import permits must be obtained in accordance with Clause 1, Article 48 of Decree No. 98/2021/ND-CP, as amended and supplemented by Decree No. 07/2023/ND-CP:

1. Importation for scientific research, testing, inspection, training on usage or repair, as stipulated in Point a, Clause 1, Article 48 of Decree No. 98/2021/ND-CP.
2. Imports to meet urgent needs for disease prevention and control or disaster relief, as stipulated in Point b, Clause 1, Article 48 of Decree No. 98/2021/ND-CP.
3. Importation as aid, gifts for medical facilities, or display at fairs and exhibitions is prohibited under Point c, Clause 1, Article 48 of Decree No. 98/2021/ND-CP.
4. Imports for direct use in humanitarian medical examination and treatment activities, as stipulated in Point d, Clause 1, Article 48 of Decree No. 98/2021/ND-CP.
5. Importation for personal medical treatment or to serve special diagnostic needs at medical facilities, as stipulated in Point d, Clause 1, Article 48 of Decree No. 98/2021/ND-CP.
6. Imports from ODA funds, preferential loans, or non-refundable aid not covered by ODA funds, as stipulated in Point e, Clause 1, Article 48 of Decree No. 98/2021/ND-CP, as amended and supplemented by Decree No. 07/2023/ND-CP.

If the import purpose does not fall into the above categories, businesses should prioritize a digital circulation strategy instead of applying for specific permits. Choosing the wrong mechanism can slow down trade plans and prolong the product-to-market cycle.

Updated legal transition roadmap according to Decree 04/2025/ND-CP

The biggest risk in 2026 is reusing old licenses or transitional customs clearance mechanisms that have expired. This is a common mistake among businesses with a portfolio of Category C and D equipment that have been imported for many years.

• Firstly, import licenses issued between 2018 and 2021 are only valid until their expiration date.30/06/2025According to Points a and b of Clause 2 and Point d of Clause 4, Article 76 of Decree No. 98/2021/ND-CP, as amended and supplemented by Decree No. 04/2025/ND-CP, the special customs clearance mechanism for medical devices of types C and D without import licenses has also ended after this date, according to Point d of Clause 2, Article 76 of Decree No. 98/2021/ND-CP, as amended and supplemented by Decree No. 04/2025/ND-CP.
• Secondly, for submitted applications that require amendment or supplementation, businesses must update them using the new form as stipulated in Clause 1, Article 5 of Circular No. 44/2025/TT-BYT.

However, businesses can still utilize some valid old documents. Authorization letters from owners and warranty eligibility certificates signed under the old regulations are still recognized if they are still valid, as per Clause 2, Article 5 of Circular No. 44/2025/TT-BYT.

Operationally, business leaders need to review the entire import catalog before placing new orders. Products lacking valid registration numbers or import licenses may be held up at customs, resulting in warehousing costs and supply chain disruptions.

Legal Requirements for Obtaining a Medical Device Import License

The legal requirements for obtaining a Medical Device Import License extend beyond simply submitting a complete set of application documents. Businesses must demonstrate legal responsibility for the imported products, the intended purpose of importation, and the legitimacy of the entire supply chain.

For Class C and Class D medical devices that have not yet been granted a Marketing Authorization Number, businesses should assess the following three key legal requirements in advance. These requirements determine both the likelihood of obtaining an Import License and the ability to complete customs clearance once the shipment arrives:

• The importing entity must assume full legal responsibility for the quality, quantity, classification, and intended end use of the medical devices, in accordance with Clause 1, Article 46 of Decree No. 98/2021/ND-CP.
• Imported products must be used strictly for the declared special-purpose import objective. An Import License may not be used for commercial purposes that are inconsistent with the approved application.
• Legal documents provided by the product owner must clearly establish the right to distribute the product, its origin, applicable quality standards, and consistency among the Certificate of Free Sale (CFS), ISO 13485 Certificate, product catalogue, and technical documentation.
• Customs authorities do not require businesses to prove compliance with warehouse facilities or specialized transportation conditions, pursuant to Clause 3, Article 47 of Decree No. 98/2021/ND-CP.

In practice, this means businesses are relieved of the burden of demonstrating storage capacity at the port of entry, but they remain fully responsible for the legal compliance of the imported medical devices. If documentation provided by the foreign manufacturer is inconsistent or incomplete, the consequences may extend beyond requests for additional documents and could delay the entire supply schedule.

Standard Application Dossier for a Medical Device Import License

An application for a Medical Device Import License must demonstrate three fundamental elements: the lawful status of the product, the legitimacy of the import purpose, and the importer’s legal authority to conduct the transaction. Businesses are advised to review all documents provided by the manufacturer before signing an import contract, as inconsistencies may delay the entire customs clearance process.

Pursuant to Clause 2, Article 48 of Decree No. 98/2021/ND-CP, as amended and supplemented by Point b, Clause 12, Article 1 of Decree No. 07/2023/ND-CP, a standard application dossier should include the following groups of documents:

• Application for an Import License, specifying the business information, medical device details, quantity, and intended purpose of importation.
• Technical Summary in Vietnamese, describing the device’s intended function, technical specifications, and scope of use.
• Quality Management System Certificate issued by the manufacturer and certified by the importing entity.
• Letter of Authorization (LOA) issued by the medical device owner, authorizing the importer to import, distribute, or use the device in Vietnam.
• A valid Certificate of Free Sale (CFS), which must be consistent with the product name, model, and product owner.
• Product catalogue, technical documentation, and instructions for use, all of which must be consistent with the product classification, the CFS, and the customs declaration dossier.
• Purpose-specific supporting documents, prepared according to the applicable special import category, particularly for ODA-funded projects, humanitarian aid, or emergency importation.

For ODA-funded projects, the application dossier may also be required to include the investment approval decision, the goods supply contract, a valid Certificate of Free Sale (CFS), technical documentation, and a Letter of Authorization from the medical device owner, as prescribed in Point o, Clause 2, Article 48 of Decree No. 98/2021/ND-CP, as amended and supplemented by Decree No. 07/2023/ND-CP.

In summary, the greatest compliance risk does not lie in the absence of a single document, but rather in inconsistencies among the submitted documents. Before filing the application, businesses should carefully verify the trade name, model number, product owner, intended use, and scope of authorization to ensure consistency throughout the dossier.

Procedures for Applying for a Medical Device Import License Through the Electronic System

The procedure for obtaining a Medical Device Import License should be managed as a regulatory compliance workflow, rather than merely a document submission process. Errors made during product classification or document preparation may result in requests for additional information, delaying the importation of medical devices into Vietnam.

Businesses are advised to implement the following five-step process to effectively manage both the application dossier and the approval timeline:

1. Determine whether the medical device has not yet been granted a Marketing Authorization Number and falls within one of the special circumstances eligible for an Import License.
2. Classify the device according to its risk category (Class A, B, C, or D) to determine the appropriate regulatory pathway.
3. Collect all required legal and technical documentation, including the Certificate of Free Sale (CFS), ISO 13485 Certificate, and the Letter of Authorization (LOA) issued by the medical device owner.
4. Submit the application electronically through the National Medical Device Management Portal to the competent authority.
5. Monitor the application review process, provide additional documents if requested, and verify the contents of the Import License once it has been issued.

This workflow enables businesses to effectively manage three major compliance risks simultaneously: selecting the wrong regulatory mechanism, lacking required documentation from overseas manufacturers, and delays in customs clearance. For medical devices imported under project-based procurement or emergency circumstances, establishing a clear implementation timeline from the outset is particularly important.

Risk Classification and Preparation of Legal Documentation

Product classification is the most critical step in determining the appropriate regulatory pathway. Before deciding whether to apply for an Import License or pursue a Marketing Authorization Number, businesses must first determine whether the medical device falls under Class A, B, C, or D.

Once the classification has been completed, the legal and supply chain teams should carefully review all documentation provided by the manufacturer. Key documents include the Certificate of Free Sale (CFS), ISO 13485 Certificate, product catalogue, technical documentation, instructions for use, and the Letter of Authorization issued by the medical device owner.

Documents issued overseas should be reviewed for their validity, scope of authorization, and eligibility for consular legalization, where required. Any inconsistency in the product name, model number, or product owner may result in requests for clarification before the application can proceed to the formal assessment stage.

Submission of the Application to the Department of Infrastructure and Medical Devices

Businesses should submit their applications to the competent authority from the outset to avoid administrative errors caused by filing with the wrong agency.

The Department of Infrastructure and Medical Devices is the central authority responsible for receiving, reviewing, and issuing Medical Device Import Licenses, pursuant to Clause 7, Article 2 of Circular No. 44/2025/TT-BYT. Accordingly, businesses should no longer use the names of former regulatory authorities in their application dossiers or explanatory submissions.

When submitting the application through the electronic system, businesses should carefully verify the document format, digital signatures, translations, and all supporting attachments. Even a minor error in the prescribed forms may prolong the processing period and affect the overall import schedule.

Review Period and Issuance of the Medical Device Import License

The statutory review period serves as an important basis for planning procurement, transportation, and customs clearance activities.

Where the application dossier is complete and valid, the competent authority will review the application and issue the Medical Device Import License within 15 working days, in accordance with Point a, Clause 3, Article 48 of Decree No. 98/2021/ND-CP.

For medical devices imported to meet urgent needs for epidemic prevention and control or disaster recovery, the review period is shortened to 2 working days, as prescribed in Point a, Clause 3, Article 48 of Decree No. 98/2021/ND-CP.

Businesses should also allocate sufficient time for potential amendments or supplementary submissions if the application does not initially meet regulatory requirements. Planning based solely on the statutory review period, while overlooking the time required to complete or revise the dossier, may significantly disrupt the overall supply chain schedule.

Customs procedures and specialized inspections for imported medical equipment

Even after obtaining an import license, businesses still have to pass the final checkpoint at the customs authority. Risks often arise when the license, classification, HS code, and goods documentation are inconsistent.

Businesses should handle customs procedures according to the following control sequence:

1. Compare the import license or registration number with the device name, model, owner, and purpose of import before filing the customs declaration.
2. Declare the HS code in accordance with the medical device classification and the product’s technical documentation.
3. Prepare customs documents including import documents, technical documents, licenses or corresponding registration numbers.
4. Monitor specialized inspections when customs authorities cross-reference information on the classification of medical devices on the Ministry of Health’s portal.
5. Inspect product labels before putting equipment into circulation, ensuring that product information does not contradict the submitted documentation.

Please note that: Customs authorities have the right to cross-check information on medical equipment on the Ministry of Health’s portal at the time of customs clearance, as stipulated in Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP, amended and supplemented by Decree No. 04/2025/ND-CP.

In terms of operations, businesses should not view import licenses as the end point of the process, because a small discrepancy between the HS code, classification, or model name can cause goods to be held at the port, incurring storage costs and delaying delivery to healthcare facilities.

Trade risks and cases of import license refusal

The biggest risk when applying for an import license is not just the rejection of the application. The practical consequences include delayed goods arrival at the port, increased storage costs, missed delivery deadlines, and impact on supply contracts with healthcare facilities.

During the evaluation process, if the application is not satisfactory, the business can only…30 days to amendments and additions since receiving the notification. After this deadline, The application was canceled. The review procedure is in accordance with Point d, Clause 3, Article 48 of Decree No. 98/2021/ND-CP.

In general, regarding internal governance, businesses should review records according to the following principles: “One product, one unified dataset” CFS, ISO 13485, catalog, technical documents, classification and customs documents must be included. They both reflect the same device.

Comprehensive Medical Device Import License Consulting and Representation Services at Long Phan Consulting Company

Importing medical devices requires consistency across product legal documentation, technical documentation, and customs information. Long Phan Consulting assists businesses in managing regulatory risks throughout the entire process, from reviewing overseas documentation to representing clients before the competent authorities.

Our service goes beyond preparing application forms. We develop a tailored regulatory compliance strategy that aligns with the commercial objectives of each medical device portfolio. Businesses should identify at an early stage which products require a Medical Device Import License and which are better suited to a long-term strategy of obtaining a Marketing Authorization Number.

Our Key Consulting Services Include:

• Conducting legal reviews of the Certificate of Free Sale (CFS), ISO 13485 Certificate, product catalogue, technical documentation, and Letter of Authorization (LOA) issued by the medical device owner.
• Reviewing the classification of medical devices according to their risk category (Class A, B, C, or D) before determining the appropriate import regulatory mechanism.
• Preparing and structuring Medical Device Import License application dossiers for various special import purposes, including scientific research, humanitarian aid, ODA-funded projects, emergency situations, and other specialized uses.
• Representing clients in providing explanations and submitting supplementary documents to the Department of Infrastructure and Medical Devices throughout the application review process.
• Verifying consistency among the Import License, Marketing Authorization Number, HS Code, product classification results, and technical documentation to minimize the risk of customs clearance delays.
• Advising businesses on transitioning from the Import License mechanism to the Marketing Authorization Number system to support long-term distribution and market expansion strategies.

Businesses are welcome to send their preliminary application dossier to info@longphanpmt.com or contact us via Zalo: (+84) 906 735 386. Long Phan Consulting will conduct an initial review and provide preliminary advice on the most appropriate regulatory approach for your products.

Frequently Asked Questions about the Latest Procedure for Obtaining an Import License for Medical Devices

Managing legal risks in import and export operations requires investors to have a thorough understanding of customs clearance exceptions and transitional periods. Mastering the specific regulations for obtaining a “Medical Equipment Import License” will help to effectively address administrative barriers and optimize warehousing costs. Further in-depth analysis will clarify common legal blind spots encountered in supply chain operations.

Conclusion

Medical equipment import licenses require careful consideration from the import planning stage, as businesses must clearly distinguish between applications for specialized medical equipment import licenses and those for medical equipment registration numbers from 2026 onwards. Incorrect classification, lack of CFS (Certificate of Free Sale), ISO 13485 certification, or valid authorization documents can lead to customs delays, increased storage costs, and disruptions to supply contracts. To manage risks related to documentation and customs clearance, please contact our hotline.1900636389 to receive support from Long Phan Consulting.