Local Authorised Representative in Vietnam
Entering Vietnam’s medical device market can be challenging, especially when navigating local regulations from overseas. That’s where Andaman Medical comes in.
As a trusted Local Authorised Representative (LAR) in Vietnam since 2017, we provide the local expertise and regulatory support you need to achieve smooth market access and ongoing compliance. We handle the complexities on your behalf, so you can focus on bringing your medical innovations to healthcare providers and patients across 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.
Why Appoint a Local Authorised Representative (LAR) in Vietnam?
Appointing a Local Authorised Representative (LAR) in Vietnam isn’t just a regulatory formality—it’s a crucial step to ensure your medical device enters the market smoothly and achieves long-term success in this growing healthcare sector. Here’s why having a Local Authorised Representative (LAR) in Vietnam is essential:
At Andaman Medical, we specialise in providing trusted and professional LAR services tailored to Vietnam’s regulatory environment. With our in-depth knowledge of local requirements, we act as your dedicated in-country representative—ensuring full compliance, managing communication with the Vietnamese Ministry of Health (MoH), and overseeing all required post-market activities.
Here’s why having a Local Authorised Representative (LAR) in Vietnam is essential:
What are the requirements for a marketing authorization holder or LAR in Vietnam?
- The in-country representative must have an Establishment License and an Investment License
- The LAR must create accounts on the DMEC and VSNW websites for medical device and in-vitro diagnostic registration with the Ministry of Health
- And in order to carry out their duties for medical devices classes B, C and D, a local authorized representative must apply for eligibility to trade classes B, C and D and obtain the Certificate of Medical Device Trading for classes B, C and D
Can you appoint multiple in-country representatives in Vietnam?
- Yes, multiple in-country representatives are allowed in Vietnam but please note that ALL LARs must register the device individually. Every time you register the device it will be evaluated as a new device application and therefore the registration fees are applicable each time
- The foreign manufacturer must issue a Letter of Authorisation (LoA) for the registration of medical devices according to the template in Circular 19/2021/TT/BYT dated on 16 Nov 2021.
- The LoA has no fixed duration.
Regulatory Requirement
Regulatory Requirement
Foreign companies without a registered office in Vietnam are legally required to appoint a Local Authorised Representative (LAR). This is mandated by Vietnamese law to ensure compliance and the ability to conduct business activities within the country.
Liaison with Authorities
Liaison with Authorities
The LAR acts as the primary point of contact between the foreign company and Vietnamese regulatory bodies, including the Ministry of Health (MOH). They handle all official communications, submissions, and negotiations on behalf of the foreign entity.
Business Registration and Licensing
Business Registration and Licensing
The LAR is responsible for filing applications and managing business registrations with Vietnamese authorities. This includes:
- Obtaining necessary licences such as the Establishment License and Investment License.
- Setting up representative offices or branches as needed.
Medical Device Registration
Medical Device Registration
To handle the registration of medical devices, the LAR must:
- Create accounts on IMDA website for medical device and in-vitro diagnostic registration with the Ministry of Health.
- Apply for eligibility to trade Classes B, C, and D medical devices and obtain the Certificate of Medical Device Trading for those classes.
Regulatory Compliance
Regulatory Compliance
The LAR ensures ongoing compliance with Vietnamese regulations by:
- Obtaining all necessary permits and licences.
- Meeting reporting and documentation requirements.
- Adhering to local laws and medical device regulations, including post-market surveillance and trade eligibility for devices.
Local Presence
Local Presence
Appointing a LAR gives foreign companies a local presence and in-depth knowledge of the Vietnamese regulatory landscape without the need to set up their own subsidiary. This provides practical business advantages and simplifies operations.
What You Need to Know About Having a Local Authorised Representative in Vietnam
To act as a Marketing Authorisation Holder (MAH) or Local Authorised Representative (LAR) in Vietnam, the following requirements must be met:
Why Choose Andaman Medical for Your In-Country Representation in the 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:
- represent your company in all dealings with the Ministry of Health responsible for medical devices and in-vitro diagnostics including:
- registering your product
- o importing your product as Andaman Medical is also an Import License Holder
- submitting change notifications
- ensuring post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events
- facilitate the importation process including customs clearance
- maintain communication with appointed distributors
- ensure that the appropriate conformity tests have been carried out, if required
- ensure that the medical device or IVD is correctly labelled and that information is provided in Vietnamese
- accept all calls from the Ministry of Health regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer including scheduling inspection(s) of the manufacturer’s facilities, if required
- maintain our office including a telephone and email connection in Vietnam
- monitor regulations to alert you to any changes or new regulations applicable to your product
