COMPANY FORMATION SERVICES (2026): SETTING UP A FOREIGN-INVESTED MEDICAL DEVICE DISTRIBUTION COMPANY IN VIETNAM
Vietnam’s healthcare and medical device market continues to attract foreign investors due to rising healthcare demand, hospital modernization, private healthcare expansion, increasing health awareness, and the need for advanced diagnostic, treatment, monitoring and rehabilitation equipment.
For foreign investors, establishing a medical device distribution company in Vietnam can be a promising business opportunity. However, medical devices are not ordinary commercial goods. They are subject to specialized regulations on classification, registration numbers, importation, trading conditions, storage, transportation, labeling, price declaration, advertising, warranty, traceability and recall.
Therefore, foreign investors should not only ask how to set up a company, but also whether the company can legally import, distribute and place the intended medical devices on the Vietnamese market.
Prospective clients seeking assistance with procedures for setting up a medical device distribution company in Vietnam are kindly invited to contact Dai Quang Minh Law Firm via Hotline: 0932 191 299; Zalo: 0932 191 299; Email: info@quangminhlawfirm.com; Viber: (+84) 337 926 405; WhatsApp: (+84) 337 926 405; WeChat: (+84) 337 926 405 (ID: pouniverse) for complimentary consultation and comprehensive, efficient, and accurate legal services.
In addition, Dai Quang Minh Law Firm provides a wide range of services, including sub-licenses, business registration, investment, foreign labor, and ongoing legal advisory services for both domestic and foreign enterprises.
Contact:
- Zalo: 0932.191.299
- Gmail: info@quangminhlawfirm.com
- Viber: (+84) 337926405/ (+84) 869672216
- WhatsApp: (+84) 337926405/ (+84) 869672216
- Wechat: (+84) 337926405 (ID: _pouniverse)/ (+84) 869672216 (ID: DQM_Verna)
- Telegram: (+84) 337926405/ (+84) 869672216
I. UNDERSTANDING THE LEGAL MODEL OF A MEDICAL DEVICE DISTRIBUTION COMPANY IN VIETNAM
The first step in setting up a medical device distribution company in Vietnam is to identify the exact business model.
A medical device distribution company may operate under different models, such as:
- Importing medical devices from overseas manufacturers;
- Buying medical devices from local registration number holders or authorized distributors;
- Distributing medical devices to hospitals, clinics, laboratories, pharmacies or healthcare facilities;
- Supplying medical devices to wholesalers, agents or retail channels;
- Providing warranty, maintenance or technical support services;
- Distributing consumables, diagnostic devices, implantable devices, hospital equipment, software as medical devices, or in-vitro diagnostic products;
- Participating in public or private procurement and bidding processes.
This distinction is important because each model may require different legal preparation.
For example, a company that only purchases medical devices from a licensed local supplier and resells them in Vietnam may follow a different compliance path from a company that directly imports medical devices from overseas. A company that distributes low-risk medical devices may face different requirements from a company handling high-risk medical devices, implantable devices, diagnostic devices or medical devices containing narcotic substances or precursors.
Foreign investors should also distinguish between company establishment, import rights, distribution rights, medical device trading conditions, and product circulation compliance. A company may be legally established, but that does not automatically mean every medical device can be imported or sold immediately.
II. CAN FOREIGN INVESTORS SET UP A MEDICAL DEVICE DISTRIBUTION COMPANY IN VIETNAM?
Foreign investors may establish a medical device distribution company in Vietnam, subject to Vietnam’s market access conditions, investment regulations and specialized medical device regulations.
Under the Law on Investment 2020, foreign investors must satisfy market access conditions when investing in sectors and trades subject to market access restrictions. These conditions may relate to foreign ownership ratio, investment form, business scope, investor capacity, partners or other requirements depending on the sector. The Investment Registration Certificate is the document acknowledging information on an investment project registered by an investor.
In practice, foreign investment in medical device distribution is generally possible, but the legal structure must be carefully reviewed. The investor should determine whether the company will import medical devices, distribute them domestically, sell to hospitals or clinics, participate in tenders, operate warehouses, provide maintenance services or act as the registration number holder in Vietnam.
The business model must also be reviewed together with the classification of the medical devices. Under Vietnam’s medical device regulations, medical devices are generally classified by risk level into Class A, B, C and D. The applicable procedures differ depending on the classification. Class A and B devices are subject to declaration of applied standards, while Class C and D devices are subject to registration procedures.
Therefore, the feasibility and licensing roadmap for a medical device distribution company depend not only on the investor’s nationality and ownership structure, but also on the specific medical devices, product classification, import plan, storage conditions and distribution channels.
WHY CHOOSE DAI QUANG MINH LAWFIRM
With years of practical experience in legal consulting, Dai Quang Minh Law Firm is a pioneer in corporate support services, specializing in fast and affordable company formation. Below are the reasons to choose business registration services at Dai Quang Minh Law Office:
Human Resources: Established in September 2009, with over 15 years of practical experience, Dai Quang Minh Law Firm brings together a team of lawyers and legal experts with long-standing expertise in private economic groups nationwide.
Consulting Policy: Clients are gifted a completely free legal consulting package when using services at Dai Quang Minh Law Firm.
Professionalism and Experience: Dai Quang Minh Law Firm has a workforce with in-depth knowledge of business formation, ensuring a swift and accurate consulting process.
Time-Saving: Using Dai Quang Minh Law Firm's services helps you save precious time as we handle the entire process and related procedures.
Legal Insight: Dai Quang Minh Law Firm ensures that all relevant legal regulations are strictly followed in accordance with the law.
Customization: Our consulting services are highly adaptable to your specific needs, allowing you to choose options suitable for your business.
Trusted Partner: Dai Quang Minh Law Firm has built a reputation for providing affordable business setup consulting to many enterprises and individuals nationwide.
Confidentiality Assurance: Dai Quang Minh Law Firm is committed to the absolute protection of your personal and business information.
Detailed Support: Dai Quang Minh Law Firm provides detailed advice and support regarding the process and requirements to help you better understand business formation.
Process Optimization: Our consulting helps optimize the business setup process, minimizing potential risks and difficulties.
Excellent Customer Experience: Dai Quang Minh Law Firm is dedicated to providing the best customer experience through professional advice and enthusiastic support.
Focus on Business Plans: By utilizing our registration services, you can focus on developing your business plans and core activities instead of worrying about legal procedures.
III. PROCEDURE FOR SETTING UP A FOREIGN-INVESTED MEDICAL DEVICE DISTRIBUTION COMPANY
For foreign investors, the establishment process usually involves investment registration, enterprise registration and post-establishment medical device compliance procedures.
Investment registration
In many cases, a foreign investor must first apply for an Investment Registration Certificate before establishing the company.
The investment registration dossier should clearly describe the investor, investment capital, project objectives, business scope, location, implementation schedule, financial capacity and proposed medical device trading activities.
For a medical device distribution company, the investment objectives should be drafted carefully. If the company intends to import, wholesale, distribute, provide warranty services, provide technical support, or participate in medical device procurement, these activities should be reviewed and reflected properly.
If the investment scope is drafted too generally, the company may later face difficulties when applying for medical device trading declarations, import procedures, product registration, business licenses, warehouse arrangements or tender participation.
Enterprise registration
After obtaining the Investment Registration Certificate, the investor proceeds to establish the Vietnamese company and obtain the Enterprise Registration Certificate.
The Enterprise Registration Certificate gives the company legal entity status in Vietnam and records key corporate information such as company name, registered address, charter capital, legal representative and enterprise code.
However, company establishment is only the first step. A company that has been legally incorporated is not automatically permitted to import and trade all medical devices. It must also satisfy applicable medical device trading conditions and product circulation requirements.
Post-establishment procedures
After incorporation, the company should complete post-establishment procedures, including tax registration, bank account opening, capital contribution, digital signature registration, e-invoice registration, accounting setup and internal corporate documentation.
Depending on the business model and product portfolio, the company may also need to review:
- Declaration of eligibility for medical device trading;
- Medical device classification;
- Declaration of applied standards for Class A and B devices;
- Registration of Class C and D medical devices;
- Import authorization from the registration number holder;
- Medical device price declaration;
- Vietnamese labeling and user manuals;
- Warehouse and transportation requirements;
- Warranty, maintenance and technical support arrangements;
- Advertising and product information compliance;
- Traceability and recall procedures.
For foreign investors, the establishment process usually involves investment registration, enterprise registration and post-establishment licensing or compliance procedures.
IV. MEDICAL DEVICE CLASSIFICATION AND PRODUCT CIRCULATION
Medical device classification is a core issue before distribution.
Under Vietnam’s medical device management system, medical devices are classified based on risk levels. Classification determines the applicable procedure for placing the device on the Vietnamese market.
For Class A and B medical devices, the registration number is generally the number of declaration of applied standards. For Class C and D medical devices, the registration number is generally the number of the certificate of registration.
The local Department of Health is responsible for notification of Class A and B medical devices, while Class C and D devices are subject to product registration with the Ministry of Health. Medical device registration numbers under Decree No. 98/2021/ND-CP are reported as valid indefinitely.
This means investors must classify products correctly before importation and distribution. Incorrect classification may lead to wrong procedures, delays, recall risks or regulatory sanctions.
V. TRADING CONDITIONS FOR MEDICAL DEVICE DISTRIBUTION
A medical device distributor must review whether it is required to declare eligibility for medical device trading.
Under Decree No. 98/2021/ND-CP, the dossier for declaration of eligibility for medical device trading generally includes a declaration of eligibility, personnel information, and documents proving that the warehouse and inventory monitoring system satisfy applicable requirements in certain cases. The trading establishment submits the dossier to the Department of Health where it is headquartered; after receipt of the dossier and fee payment, the Department of Health publishes the relevant information and dossier on the medical device management portal.
However, not all medical device trading activities follow the same path. Class B, C and D medical devices included in a list issued by the Minister of Health may be traded as normal goods and are not required to satisfy the trading eligibility requirements or follow the declaration procedure, provided that storage and transport requirements prescribed by the device owner are still met.
Therefore, before commencing business, the company should classify the medical devices and check whether the specific products require a trading eligibility declaration or fall under an exemption.
VI. IMPORTATION OF MEDICAL DEVICES
If the foreign-invested company imports medical devices into Vietnam, import compliance must be reviewed carefully.
For medical devices that have been granted registration numbers, an organization or individual wishing to import the device must generally be the registration number holder or must have an authorization letter from the registration number holder. When authorizing import, the registration number holder must send a copy of the authorization letter to the registration number issuer and the customs authority.
The importer should also ensure that the devices satisfy storage and transport requirements. Where the company does not directly operate qualified storage or transport facilities, it may need contracts with qualified storage and transportation service providers depending on the device type and applicable requirements.
In practice, import delays often arise because the importer has not prepared the authorization letter, product registration number, classification results, labels, technical documents, invoice, packing list or customs documents consistently.
Therefore, import documentation should be reviewed before shipment, not after the goods arrive at the port.
VII. PRICE DECLARATION, LABELING, ADVERTISING AND TRACEABILITY
Medical device distribution companies must also pay attention to ongoing compliance obligations.
Price declaration
Medical device price management is a significant compliance issue. Decree No. 98/2021/ND-CP provides that medical device prices must be declared before the devices are placed on the Vietnamese market and re-declared whenever prices change. Trading establishments are not allowed to trade medical devices before prices are declared or at prices higher than those published on the Ministry of Health’s medical device management portal at the time of trading.
Labeling and user manuals
Registration number holders must provide adequate and accurate information on labels and user manuals in accordance with goods labeling rules and medical device regulations. They must also provide accurate warnings about risks to users’ health and the environment and instructions for sellers and users to minimize risks.
For imported medical devices, Vietnamese labels or supplementary labels should be reviewed before market circulation.
Advertising and product information
Medical device advertising must be consistent with the published or registered product information. The registration number holder or authorized entity assumes legal responsibility for the conformity of advertising contents with the published information and the application for declaration or registration.
Companies should avoid overstating product functions, making unapproved claims, or presenting devices in a way that differs from the registered intended use.
Traceability, warnings and recall
Registration number holders are responsible for preparing and keeping documents on medical device management, tracing origin, issuing warnings, stopping circulation, taking corrective actions and recalling defective devices where required.
For distributors, this means supplier records, batch information, import records, customer records, warranty documents and recall procedures should be maintained carefully.
Prospective clients seeking assistance with procedures for setting up a medical divice distribution company in Vietnam are kindly invited to contact Dai Quang Minh Law Firm via Hotline: 0932 191 299; Zalo: 0932 191 299; Email: info@quangminhlawfirm.com; Viber: (+84) 337 926 405; WhatsApp: (+84) 337 926 405; WeChat: (+84) 337 926 405 (ID: pouniverse) for complimentary consultation and comprehensive, efficient, and accurate legal services.
In addition, Dai Quang Minh Law Firm provides a wide range of services, including sub-licenses, business registration, investment, foreign labor, and ongoing legal advisory services for both domestic and foreign enterprises.
Contact:
- Zalo: 0932.191.299
- Gmail: info@quangminhlawfirm.com
- Viber: (+84) 337926405/ (+84) 869672216
- WhatsApp: (+84) 337926405/ (+84) 869672216
- Wechat: (+84) 337926405 (ID: _pouniverse)/ (+84) 869672216 (ID: DQM_Verna)
- Telegram: (+84) 337926405/ (+84) 869672216
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