Medical device importation to Vietnam

Only registered medical devices may be imported into Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health (MoH) and been issued with a Notification of Applicable Standard or Circulation Registration Certificate unless exempted from registration (see below). All medical devices and in-vitro diagnostics that are in circulation in Vietnam as well as those that are exported are listed in the DMEC portal system.

What are the requirements for importing medical devices into Vietnam?

Are there any exemptions or exclusions?

Special Access Routes for importing medical devices into Vietnam

Importers duties and obligations

It is mandatory for importers of medical devices and IVDs to Vietnam to store the following quality control documents:

Importers must also:

How Andaman Medical can help with importing medical devices to Vietnam:

Andaman Medical holds a valid license to operate as an importer of medical device and in-vitro diagnostics as well as being able to authorize other third parties to import medical devices and in-vitro diagnostics. We remain independent from any final distribution channel partner you choose to appoint, giving you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to:   

We also offer additional support services such as:

Obtain a quote on accessing the Vietnamese medical device market

Medical device distribution in Vietnam

Only registered medical devices may be distributed in Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health (MoH) and been issued with a Notification of Applicable Standard or Circulation Registration Certificate also known as the Product License unless exempted from registration (see below). All medical devices and in-vitro diagnostics that are in circulation in Vietnam as well as those that are exported are listed in the DMEC portal system.

Who can distribute medical devices in Vietnam?

What are the requirements for distributing medical devices in Vietnam?

Advertising rules

Advertising, communication and promotion of medical device is a common part of a distribution contract. In Vietnam, the promotion and marketing of medical devices must comply with Decree 98/2021/ND-CP . Only the License Holder or those entities who are authorized by the License Holder may declare the information of the advertising content to the DMEC prior to the promotion and marketing of medical devices. The contents of promotion and advertising must be consistent with the Notification of Applicable Standard dossier of class A and class B medical devices and the Circulation Registration dossier of class C and D medical devices.

Distributor’s duties and obligations

It is mandatory for distributors of medical devices and IVDs to Vietnam to store the following quality control documents:

Distributors must also:

How Andaman Medical can help with distributing medical devices to Vietnam:

Andaman Medical holds a valid license to operate as an importer and master distributor of medical device and in-vitro diagnostics as well as being able to authorize other third parties to import and distribute medical devices and IVDs. We remain independent from any final distribution channel partner you choose to appoint, giving you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to:   

We also offer additional support services such as:

Get a quote on our how we can help you access the Vietnam medical device market

Medical device registration in Vietnam

All medical devices, whether manufactured domestically in Vietnam or imported, must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health. 

Who can register a medical device in Vietnam?

Only companies registered locally in Vietnam and who have a valid Establishment License from the Local Department of Planning and Investment may register a medical device. These organizations must declare applicable standards or register the circulation of medical devices in Vietnam include: 

a) Vietnamese enterprises, cooperatives and household businesses that own medical devices

b) Vietnamese enterprises, cooperatives and household businesses that trade medical devices and are authorized by owners of medical devices to register

c) Standing representative offices in Vietnam of foreign traders who own medical devices or are authorized by owners of medical devices. 

As only local (Vietnamese) companies can apply for an establishment license, foreign manufacturers, therefore, have three (3) possibilities to register their medical device in Vietnam: 

Set up a legal subsidiary entity

to register the medical device. This will require registering with the local Department of Planning and Investment, obtaining investment certificates and a business license.

Appoint a local importer or distributor

who has a valid establishment license to register the medical devices.

Appoint an independent third party

such as Andaman Medical to register the medical devices. Andaman Medical has a valid Medical Device Establishment License and is a licensed Local Authorized Representative which means we act directly on behalf of foreign manufacturers and distributors and can register all classes of medical device, A, B, C and D. We register and maintain your device license which means you have the freedom to appoint as many importers or wholesalers for your device as you require while the product license will not be affected by any changes in the distributor network. Andaman Medical is also a licensed importer of medical devices – please refer to our importation of medical devices to Vietnam page for more details.

Classification of medical devices in Vietnam

Medical devices are divided into 2 types:

  1. Medical devices (non-IVDs): includes equipment, tools, materials, implant materials, reagents, in vitro calibration materials and software that simultaneously satisfy all following requirements: Used independently or in combination with each other according to designation of owners of medical devices to serve humans for following purposes: Diagnosis, prevention, monitor, treatment and relief of diseases or injury compensation; Checking, replacement, modification or surgery and physiological process support; Life support or sustainment; Conception control; Sterilization of medical devices, including chemicals used during diagnosis; Provision of information for diagnosis, monitor and treatment via examination of specimens taken from the human bodies.

    Medical devices must not use pharmacological, immune or metabolizing mechanisms in or on human bodies in order to achieve its primary intended action however these mechanisms may assist in achieving this purpose.
  1. In vitro diagnostic medical device (IVDs): consists of reagents, calibration materials, control materials, kits, machines, devices or systems that are used independently or in combination with each other as requested by owners thereof to serve examination of specimens taken from the human bodies.

Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostic medical devices.

Medical devices in Vietnam are classified in terms of risk in accordance with the ASEAN Medical Device Directive (AMDD), which lists 4 classes:

Class A

Low Risk

Class B

Low to Moderate Risk

Class C

Moderate to High Risk

Class D

High Risk

Medical device grouping in Vietnam

Medical devices and IVDs can be grouped and registered as one application in order to obtain one medical device registration certificate: Notification of Applicable Standard certificate for Class A and B products or the Circulation Registration Certificate (Product license) for classes C and D. Medical devices that apply for registration as a group will base on:

The grouping categories are as follows:

Medical device grouping in Indonesia Single

Single

Medical device grouping in Indonesia Family

Family

Medical device grouping in Indonesia System

System

Medical device grouping in Indonesia Group

Set

Medical device grouping in Indonesia IVD Test

IVD Test Kit

Medical device grouping in Indonesia IVD Cluster

IVD Cluster

The registration processes

First of all, the classification risk and result of a medical device should be determined. The classification result will be issued by an applicant/license holder.

Upon determining the classification, class A and B medical device registration applications must be uploaded to the local department of health via online portal https://dmec.moh.gov.vn/.  Upon approval a Notification of Applicable Standard will be issued. This has a lifetime validity.

All class C and D medical device registration applications must be submitted to the DMEC via the online portal. Upon approval, a Circulation Registration Certificate (Product license) will be issued. The circulation registration certificate (product license) do not have expiration date/validity. The product license of class C, D will be fully implemented from 1st Jan 2023.

 The filing of applications for medical device product registrations shall follow the guidelines under Decree 98/2021/ND-CP. Once the necessary documentation has been uploaded according to the product’s classification and group, the registrant can process the payment at the same time.

What documents are required to register medical devices in Vietnam?

Various documentation, both legal and technical, is required to register a medical device in Vietnam. Legal documents include: Free sale certificate, Letter of authorization, ISO 13485 certificate.  Technical documents include the classification result, technical brief, instruction for use (Vietnamese), labelling, catalogue. In addition, the summary of clinical trial data is required for medical device classes C and D invasive in human body.

Medical devices which are measurement instruments require additional documentation such as sample approval, inspection and calibration under Ministry of Science and Technology responsibility.

Typical fees and timelines

A fee is payable for each submission for medical device registrations and import licenses. These are non-tax fees. The fee regulated in Circular 278/2016/TT-BTC.

The registration application for class A and B devices will be approved and signed by the Department of Health where the registrant is located and normally takes about 7-10 working days for approval.

Whereas the registration application for class C and D products are approved and issued by the Department of Medical Equipment and Construction and is estimated about 6 (six) to 12 (twelve) months once the DMEC commences evaluations (see above point in the registration process).

For medical device and IVD new registrations and import licenses:

Class Fee Timeline
Class A 1,000,000 VND (~44 USD) 7-10 working days
Class B 3,000,000 VND (~130 USD) 7-10 working days
Class C and Class D 5,000,000 VND (~217 USD) 6-12 months

How Andaman Medical can help:

Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.

Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.

Our registration services include:

Our authorised representative services include:

We also offer additional support services such as:

Want to know more how we can help you register your products in Vietnam?

Post Market Surveillance of Medical Devices in Vietnam

The Department of Medical Equipment and Construction (DMEC) of the Ministry of Health (MoH), requires foreign manufacturers to undertake post-market surveillance (PMS) in accordance with the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. However, each ASEAN member state is free in implementing these PMS requirements and each country has its own specificities, please read on to understand how post market surveillance is implemented in Vietnam.

What are the medical device PMS requirements in Vietnam?

The MoH issued guidelines for PMS activities which are regulated for by Decree 36 and Decree 169 regarding medical device management. The guidelines specify:

Documentation for after-sale management of medical devices in Vietnam

License Holders must store the following documents:

Importers must store the following quality control documents:

Mandatory reporting responsibilities

License Holders have varying mandatory reporting responsibilities and actions to be undertaken according to the gravity of the incident relating to their medical device.  

In cases where medical devices harm users' health, license holders are responsible for:

a) suspending circulation of the medical device
b) informing the Ministry of Health, organizations and individuals distributing and using the medical device in writing. The notice must specify the batch number and the defect that pose harm to health of users and whether or not the defect can be rectified
c) preparing plans to rectify or recall batches of the defective medical device
d) reporting to Ministry of Health after completing any rectification or recall.

In cases where medical devices have caused serious threat to public health or the death of users, license holders are responsible for:

a) informing on the license holders’ website (if it exists), sending notice about the adverse event to facilities that trade or utilize the batches medical devices and to Ministry of Health
b) suspending circulation of the medical device
c) conducting investigations and verification to determine the reason for the case
d) reporting to the Ministry of Health after receiving investigation and verification results. In cases where incidents are identified to be caused by defects of medical devices, specify the defects and whether or not rectification of the defects is possible. Rectify or recall batches of defective medical devices and report to the Ministry of Health after completing rectification or recall.

In cases where medical devices do not cause death of users but pose serious threats to public health license holders are responsible for:

a) informing the Ministry of Health about the incident
b) conducting investigations and verification to determine the reason for the case
c) reporting to the Ministry of Health after receiving investigation and verification results. In cases where incidents are identified to be caused by defects of medical devices, specify the defects and whether or not rectification of the defects is possible. Rectify or recall batches of defective medical devices and report to the Ministry of Health after completing rectification or recall.

After receiving the relevant report from the license holder, the Ministry of Health is responsible for suspending circulation of the concerned medical device batch(es) or for issuing decisions for the recall of defective medical device batch(es).

What are the timelines for adverse event reporting?

All cases should be reported and informed to authorities and medical establishments within 30 days from the date the manufacturer, importer or distributor is made aware of the adverse event.

How Andaman Medical can help you with post-market surveillance in Vietnam

With 6 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including Adverse Event and Mandatory Reporting. Our local, in-house staff liaise with the Ministry of Health to help you maintain compliance once your medical device is placed on the market. Our services include:

Get a quote on our PMS services in Vietnam

Local authorised representative in Vietnam

The Ministry of Health in Vietnam requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as the in-country representative or marketing authorization holder.

Andaman Medical has been a local authorized representative in Vietnam since 2017.

What are the requirements for a marketing authorization holder or LAR in Vietnam?

Can you appoint multiple in-country representatives in Vietnam?

How Andaman Medical can help with in-country representation in Vietnam:

As your marketing authorization holder or local authorized representative in Vietnam we will:

Get a quote for in-country representation services in Vietnam

Vietnam’s Medical Device Market

The medical device market in Vietnam

Regulatory authority and laws governing medical devices in Vietnam

Vietnam’s healthcare system

Industry associations

Key exhibitions and events

General economic and demographic statistics

How Andaman Medical can help you access the Vietnam medical device market

Regulatory Services for Vietnam

Market Access Services for Vietnam

Obtain a quote on accessing the Vietnam market

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