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:
- 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.
- 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:
- Intended use
- Legal manufacturer
- Classification result
The grouping categories are as follows:
Single
Family
System
Set
IVD Test Kit
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:
- Standard product registration
- Abridged product registration
- Special access product registration
- Renewal of product registration
- Amendment and change notification
Our authorised representative services include:
- Liaison with the local authorised government agency on all regulatory issues relating to your medical device including amendment and change notifications
- Regulatory monitoring to alert you to any changes or new regulation applicable to your product
- License holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
We also offer additional support services such as:
- Regulatory intelligence reports giving your insight into the best routes for market access and the latest on the regulatory landscape in your target market
- Importation
- Storage and warehousing
- Relabelling
- Online regulatory training