A Comprehensive Overview Of Medical Devices Compliance in Vietnam

Vietnam's medical device market is expanding, with the Ministry of Health expecting the domestic market to exceed US$2.5 billion by 2030 if its current growth trajectory continues. Around 90% of medical equipment is imported, creating opportunities for international manufacturers and distributors entering the market.

Vietnam's medical device sector is governed by specific requirements covering device classification, registration, import, distribution and post-market compliance. Medical devices are classified into four risk-based categories, Classes A, B, C and D, with regulatory requirements varying according to the device's risk level.

This guide explains Vietnam's medical device classification and registration framework, key considerations when importing medical devices, required documentation and common compliance risks for foreign businesses.

Definition of Medical Equipment

Under Vietnam's current medical device regulations, a medical device is an instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software intended for use, alone or in combination, on humans for one or more medical purposes. These include the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury; investigation, replacement, modification or support of anatomy or physiological processes; supporting or sustaining life; controlling conception; disinfecting medical devices; and providing information for diagnosis, monitoring or treatment through the examination of human-derived specimens.

A product is considered a medical device where its principal intended action in or on the human body is not achieved through pharmacological, immunological or metabolic means, although these mechanisms may assist its function. This distinction helps differentiate medical devices from medicinal products.Simple devices like stethoscopes, thermometers, and bandages.

Medical Equipment Classification

The ASEAN Medical Device Directive (AMBDD) and the Global Harmonisation Task Force of WHO classify medical equipment in the following categories, which are also followed by the Vietnamese government. 

• Class A: These are low-risk medical equipment like hospital beds, surgical gloves, cotton, bandages, etc. Medical equipment manufacturers need not bother about licenses to supply these. 

• Class B: Low-moderate-risk medical devices like electronic thermometers, pregnancy kits, breathing masks, etc. fall under this category. 

• Class C: This includes high-moderate-risk medical equipment like implants, electric scalpels, condoms, etc. 

• Class D: This category is reserved for high-risk medical devices like artificial bones, surgical kits, antibacterial gauze, etc. Medical equipment distribution companies need to have a license to manufacture and sell these products, as they require quality control and precision along with highly trained personnel diligently following certified processes. 

Medical Device Classification in Vietnam

Vietnam classifies medical devices into four categories according to their level of risk:

• Class A: Low-risk medical devices.

• Class B: Low-to-moderate-risk medical devices.

• Class C: Moderate-to-high-risk medical devices.

• Class D: High-risk medical devices.

The applicable registration and compliance requirements depend on the device's classification. Businesses should therefore confirm the correct classification before proceeding with registration or market entry.

Medical Device Registration Fees in Vietnam

Applicable fees vary depending on the device classification and regulatory procedure. From 1 July 2025 to 31 December 2026, the applicable fees include:

• Class A: VND 500,000 per application for publication of applicable standards.

• Class B: VND 1.5 million per application for publication of applicable standards.

• Class C and D: VND 3 million per application for a new circulation/marketing authorisation number.

From 1 January 2027, the scheduled fees increase to VND 1 million for Class A, VND 3 million for Class B, and VND 6 million for Class C and D.

Medical Equipment Registration in Vietnam

Vietnamese regulations mandate that medical devices compliance follow different registration procedures for different classes of equipment. As per the Ministry of Health’s Department of Medical Equipment and Health Works (DMEHW), all medical equipment distribution companies need to abide by strict criteria to get a license to sell their products.

For Class A and B instruments, medical equipment manufacturers must submit the “Declaration of Applied Standard” to the nearest branch of the Health Department, which will authorise them to sell the product for 1-3 months by providing a marketing authorisation code (MAC). Meanwhile, for Class C and D instruments, a Declaration of Applied Standard should be submitted at the local health department, which will grant you a MAC code to sell the products for 6–12 months, with a provision to extend it to 18 months. 

Required Documents for Medical Device Class A Registration

All the above docs must be translated to Vietnamese by the authorised/ licensed translator in Vietnam or the Viet Embassy, except for the passport

Required Documents for Medical Device Class B, C, D Registration

All the above docs must be translated to Vietnamese by the authorised/ licensed translator in Vietnam or Viet Embassy except for passport

Foreign companies should take note of the quick registration and emergency registration procedure of Class C and D medical devices, which grants you approval in 10 days instead of the regular 45-day wait. The quick method applies to equipment with authorisation from the US FDA, Medical Devices Agency of Japan, Health Canada, Therapeutic Goods Administration of Australia, UK or Chinese state agency, etc., along with a license to import to Vietnam. Meanwhile, the emergency method is applicable for products meant for epidemic prevention or those used to contain disease outbreaks in natural disasters as authorised by the WHO or EU Health Security Committee.

7 Key Considerations When Importing Medical Devices in Vietnam

1. Timeline Matters When Importing Different Types of Medical Devices

Investors planning to enter Vietnam’s medical device market must factor in regulatory timelines as a critical consideration. While Type A and B devices like blood pressure or glucose monitors can be self-declared and approved in as little as one month, Type C and D devices involve a far more complex and prolonged process. These higher-risk products require full registration and government approval, which can take up to 2 years.

Costs are also significantly higher often double that of Type A and B devices, excluding government fees. Extended delays are common due to the need for supplemental documentation and opaque rejection reasons. Understanding these timelines early is essential for planning market entry and managing investor expectations.

2. Certificate of Free Sale(CFS) As A Key Paper To Obtain Before Importing

One of the most critical documents in the registration process is the Certificate of Free Sale (CFS). For Vietnam’s authorities, the CFS not only confirms that the medical device is legally marketed in the country of origin but also demonstrates the product’s safety and quality. A valid CFS enhances the credibility of the device by proving that it has undergone regulatory evaluation and is in active use in its home market. For investors, securing a CFS is not just a procedural requirement.

Instead, it is a mandatory condition for import approval and a key foundation for product classification. Without it, or with discrepancies in the stated purpose, businesses risk rejection or even recall of imported goods. Understanding the role of the CFS is essential to ensuring smooth market access and avoiding regulatory pitfalls.

3. Importers Bear Full Responsibility for Medical Device Classification

Under Decree 98/2021, the responsibility for classifying medical devices now lies directly with the importing company. While this gives businesses more autonomy, it also introduces substantial risk—many companies lack the technical expertise to accurately determine the correct classification, which in Vietnam is primarily based on the intended use of the product and supported by documents like the Certificate of Free Sale (CFS). Incorrect classification can lead to serious consequences, including the revocation of all imported goods. As such, it is crucial that importing companies thoroughly understand their products and seek guidance from regulatory experts to ensure compliance from the outset.

4. Ensure Product Labels Match Registration Information

Importers must ensure that the information on the medical device label matches exactly what was disclosed during product registration. According to Decree 98/2021, once a product is declared, the imported product must reflect that identical information. Any inconsistency between the label and the registered details can lead to regulatory issues unless the change has been properly re-declared. This includes changes in product classification, intended use, manufacturing site, or even the product code listed in the Certificate of Free Sale (CFS).

In such cases, the importer must undergo a new product declaration process, which may significantly delay import timelines. To avoid disruption, businesses should verify that labeling and registration data are fully aligned before importing.

5. Local Presence and Licensing Are Necessary for Import and Distribution

Foreign medical device manufacturers entering Vietnam need to establish the appropriate local arrangement for registration, distribution and after-sales obligations.

Under Vietnam's medical device regulations, the organisation responsible for declaring applicable standards or registering a device may be a Vietnamese entity authorised by the device owner, or a permanent representative office in Vietnam of a foreign trader that owns or is authorised by the device owner.

The organisation named in the registration or declaration must also have a warranty facility in Vietnam or an agreement with a qualified warranty service provider, where required.

The specific requirements depend on the device classification, ownership structure and applicable market-entry procedure. Businesses should confirm the appropriate registration and distribution arrangement before importing or placing medical devices on the Vietnamese market.

6. Stricter Product Audit and Inspection

In Vietnam, the audit and inspection of products are primarily conducted by several government agencies, depending on the type of product and industry. Key authorities include:

1. Ministry of Health (MOH)/Department of Health in Ho Chi Minh City: Responsible for food safety and health-related products, conducting inspections to ensure public health standards.

2. General Department of Quality Supervision: Engages in quality control and market surveillance.

How the audit mechanism works?

• Risk-Based Approach: Inspections are often based on risk assessments, focusing on products with higher potential for non-compliance + double check legal documents of the products.

• Regular Inspections: Routine audits may occur annually or biannually, depending on the product category and previous compliance records.

• Surprise Inspections: Authorities can conduct unannounced inspections to ensure ongoing compliance.

• Sampling and Testing: Products may be sampled for quality and safety testing, especially in the food and health sectors.

The frequency of audits varies by product type. High-risk products may be inspected more frequently (e.g., quarterly), while lower-risk items might only be audited once a year.

In June 2025, due to hot issues in non-compliance and fake products in the market, the inspection may happen more often and serious than its usual. In this situation, please make sure that the VN company keeps sufficient documents and records of the registered products.

Medical Equipment Purchasers

Foreign medical equipment manufacturers should keep in mind the following categories of buyers to avoid any medical device compliance issues. In Vietnam, there are essentially four types of medical equipment purchasers:

• Government hospitals, clinics and health centers: Around 70% of the medical equipment used in Vietnam is purchased by public hospitals and healthcare facilities. Foreign companies can sell their products in these centers if they tie up with a local partner.
• Private hospitals.
• Foreign-owned hospitals and clinics.
• Research institutes.

Common Risks for Medical Devices Investors

One recurring issue faced by our clients entering the Vietnamese medical device market is incomplete or improperly prepared documentation during product classification. Many foreign investors overlook the importance of aligning document preparation with both Vietnamese regulatory requirements and the appropriate risk classification (A, B, C, or D). Even minor errors such as missing details or outdated certificates can result in lengthy delays in the authorisation process.

A common pitfall is the submission of documents where ISO certifications have expired in the home country, leading to compliance rejections. Furthermore, high-risk devices (Class C and D) are subject to stricter scrutiny and may require clinical trials on humans to validate safety before approval. If documentation is not properly legalised or translated, it can extend the registration process by up to a year. These challenges highlight the need for thorough preparation and consultation before attempting product registration in Vietnam.

How can Ascentium Vietnam Can Help

Entering Vietnam's medical device market involves several regulatory steps, from product classification and documentation to registration and market-entry requirements.

Ascentium Vietnam helps businesses understand the requirements that apply to their products and prepare for the relevant registration and compliance procedures. Our local team provides clear guidance throughout the process, helping businesses identify requirements early and address potential compliance issues before they cause delays.

Frequently Asked Questions