The Complete Guide to Medical Device Registration in Vietnam (Updated)

To import, manufacture, or distribute medical devices in Vietnam, you must register your products with the Infrastructure and Medical Device Administration (IMDA), under the Ministry of Health (MoH). It is a mandatory legal requirement to ensure the safety and efficacy of medical products in the Vietnamese market. 

In this guide, we will break down what you need to know about medical device registration in Vietnam. We will give you a roadmap from pre-registration requirements to the review process.

Understanding the Medical Device Regulations in Vietnam

As of January 2025, the MoH has restructured the registration authority from the Department of Medical Equipment and Construction (DMEC) into the Infrastructure and Medical Device Administration (IMDA). The new institution now oversees registration and healthcare infrastructure in Vietnam. 

Medical Device Risk Classification 

Vietnam follows the ASEAN Medical Device Directive (AMDD). This classifies medical devices into different classes (Class A to D) based on the “risk factor” of each device. Higher classifications will require extensive documentation and a longer review process by their designated local governing units. Classifications also affect the review timeline and registration fees. 

Here is how medical devices are classified according to the AMDD:

• Class A (Low Risk): Basic items like bandages, non-invasive exam lights, hospital beds, or simple surgical instruments. These follow a “Notification” process.
• Class B (Low to Moderate Risk): Items like surgical gloves, certain catheters, or basic diagnostic tools. These also follow a simplified notification process.
• Class C (Moderate to High Risk): Contact lenses, hemodialysis machines, ventilators, and many IVD reagents. These require a full technical review.
• Class D (High Risk): Anything that stays in the body (implants), heart valves, or devices that interact with the central nervous system. These undergo the most rigorous scrutiny.

If a device has multiple uses with different risk levels, it is classified based on the highest risk level.

Choosing Your Local Representative (MAH)

As a foreign company, you must have a legal anchor in Vietnam before you can register a medical device. You can incorporate your own company in Vietnam, allowing you to manage the device registration process directly and obtain all the necessary permits. However, this can be a costly and time-consuming process. 

Most foreign companies would simply appoint a local representative or a Marketing Authorization Holder (MAH). This is the entity that holds all the necessary licenses and certifications. This way, you don’t need to start a new company just to register your medical device. 

Emerhub can act as your local agent in Vietnam to facilitate the registration process. We offer local import and distribution services, ensuring full compliance with all regulatory requirements to support your planned expansion in Vietnam.

Quality Management (ISO 13485)

Regardless of the device’s class, the manufacturer must have a valid ISO 13485 certificate. Under Decree 98 and Decree 07, ISO 13485 is a strict prerequisite for both the “Notification” of Class A/B devices and the “Marketing Authorization” of Class C/D devices. Without it, the IMDA will not even open your digital application.

The ISO certificate should cover the specific device you are trying to register in Vietnam. For example, if you are registering an ultrasound device but your ISO only mentions “surgical tools,” the IMDA will reject the application immediately.

The IMDA typically requires that the certificate has at least 6 months of validity remaining at the time of submission.

Required Documents for Medical Device Registration in Vietnam

Before any formal submission, you must make sure you have the right documents and a dossier of your medical devices. All key documents (e.g. Power of Attorney ISO 13485, technical descriptions) must be in Vietnamese. Bilingual formats (Vietnamese + English) are often accepted for Instruction for Use (IFU) and labeling samples. 

Administrative Documentation

These documents are essential for providing IMDA with verified evidence that your company is a legitimate manufacturer or importer. It also helps certify that your products have already successfully cleared rigorous safety benchmarks in its home market. 

• Certificate of Free Sale (CFS): Proof the device is sold in its country of origin or a reference country (US, EU, Japan, etc.). It must be current and legalized.
• Power of Attorney (POA): A specific template authorized by the MOH that gives your local representative the right to submit and manage the registration on your behalf.
• Warranty Certificate: For any device that isn’t single-use, the manufacturer must provide a document outlining how the device will be serviced and warrantied within Vietnam.

The CSDT Technical File 

Since January 2024, Vietnam has fully adopted the CSDT (ASEAN Common Submission Dossier Template) for Class C and D devices. This is a high-level technical file that requires professional preparation. The CSDT is divided into several sections that must be perfectly organized:

1. Executive Summary: A high-level overview of the device, its intended use, and its history in other markets.
2. Essential Principles: A checklist showing how your device meets the safety and performance requirements of the ASEAN Medical Device Directive.
3. Device Description: A technical breakdown of materials (e.g., biocompatible plastics, electronic components), software versioning, and the mechanism of action.
4. Risk Management: A summary of your ISO 14971 risk files. The regulators want to see that you have identified every possible hazard and implemented controls to mitigate them.
5. Clinical Evaluation: For Class C and D, you must provide summaries of clinical trials or literature reviews that prove the device does what it says it does.

Language and Labeling Requirements

Proper labeling is crucial in preparing your medical devices for sale and distribution in Vietnam. Remember that labeling regulations can differ from country to country, meaning that foreign manufacturers often need to update labels for the Vietnamese market. 

The country enforces strict labeling requirements, and compliance is essential to avoid penalties from local authorities. Labels must include:

• Name and address of the legal manufacturer (device owner)
• Name and address of the registration number owner (company or individual who is the registrant)
• Registration number or import license number (if the registration number is unavailable)
• Batch or serial number
• Manufacture date or expiry date
• Warnings
• Instructions for use
• Instructions for storage
• Origin of goods
• Product Name

Furthermore, all labels must be in Vietnamese. If your product label is in a foreign language, a supplementary Vietnamese label must be added to the device without altering the original label.

If the original box is in English, the importer must affix a Vietnamese sub-label before the product is cleared by customs. This label must include the registration number, name of the importer, and essential safety warnings.

Medical Device Registration Pathways

Medical device registrations are now processed through the unified online portal (dmec.moh.gov.vn). Although it is automated, the technical review is still done by human experts at IMDA. 

The complexity of the product registration process primarily depends on the classification of your device. Class A and Class B only require a “Notification” meanwhile Class C and D requires a full registration. 

Class A & B Notification

For Class A and B devices, the process is a Notification (Declaration of Applicable Standards – DoAs). Within 7-10 working days after Emerhub’s local representative submits the application, the Provincial Department of Health issues a “Receipt of Declaration.”

As soon as you have that receipt number, you can legally import and sell. There is no “review” period where you wait for a human to read the file. The responsibility for accuracy lies entirely on the MAH. 

Class C & D Registration

Unlike a notification for Class A and B devices, Class C and D requires a Circulation Registration Certificate (CRC). It confirms that your devices have undergone thorough regulatory review of technical dossiers. The IMDA sends your CSDT to a committee of experts who review the technical data. They are looking for consistency between your claims and your test data.

During this process, it is common to receive a “Request for Information” (RFI) asking for more information about your product. You usually have 60 days to answer their questions. If you fail to answer adequately, the application is cancelled, and you lose your submission fee.

Because these products have higher risk levels, IMDA usually reviews Class C and D products for up to 6 to 12 months. 

The Fast-Track (Abridged Review)

If your device is already approved in a “Reference Country” (USA, EU, Australia, Canada, Japan, South Korea, or China), you can apply for an Abridged Review. 

The IMDA will not re-evaluate your raw clinical data. Instead, they will rely on the evaluation already performed by the reference regulator. This significantly reduces the technical questions asked by the reviewers and can shave 3-5 months off the total registration time.

Simplify your Medical Device Registration with Emerhub

As your Independent Marketing Authorization Holder (MAH), Emerhub is your partner while you maintain the flexibility to work with any distributor you choose. We handle the CSDT preparation, and the legalized paperwork to streamline the registration process. 

After approval, we will ensure continued compliance with the requirements and regulations for your medical devices. This includes adhering to label regulations, conducting post-market surveillance, and maintaining product safety and efficacy.

Schedule a free assessment with our local compliance experts in Vietnam.