Local Authorised Representative in Vietnam
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.
Vietnam Local Authorized Representative for MoH/DMEC Registration & Regulatory Support
Preparing to enter Vietnam’s medical device market and need clarity on local regulatory requirements? Foreign manufacturers without a local subsidiary must appoint a Local Authorised Representative (LAR) to act as their official in-country regulatory contact. The LAR ensures your medical devices comply with Vietnam’s Ministry of Health (MoH) requirements and supports your market entry from registration through post-market obligations.
At Andaman Medical, we provide the local regulatory expertise needed to navigate Vietnam’s approval processes with confidence. Since 2017, we have supported manufacturers by managing product registration, licensing, communication with the MoH, post-market surveillance, adverse event reporting, and all ongoing compliance activities required to maintain market access.
Why Appoint a Local Authorised Representative in Vietnam?
- Meet mandatory MoH requirements for foreign manufacturers
- Ensure clear, consistent communication with regulatory authorities
- Navigate Vietnam’s evolving submission and approval pathways with local expertise
- Maintain ongoing compliance through structured post-market and vigilance activities
- Support your long-term presence in an expanding and highly regulated healthcare environment
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:
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
Get a quote for in-country representation services in Vietnam
Why Choose Andaman Medical?
