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
In compliance with the Ministry of Health regulations, foreign manufacturers without a legal subsidiary in Vietnam must appoint a Local Authorised Representative (LAR), also known as an in-country representative or marketing authorisation holder.
Andaman Medical has served as a Local Authorised 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:
Why Appoint a Local Authorised Representative (LAR) in Vietnam?
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.
Why Choose Andaman Medical for Your In-Country Representation in the Vietnam?
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 Vietnam?
Regulatory Representation
Represent your company in all dealings with the Ministry of Health for medical devices and in-vitro diagnostics.
Product Registration and Importation
- Register your medical devices with the Ministry of Health.
- Facilitate product importation, including customs clearance, as Andaman Medical is also an Import License Holder.
Regulatory Submissions
- Submit change notifications when required.
- Ensure post-market surveillance, including Adverse Event Reporting.
Distributor Coordination
Maintain communication with your appointed distributors to ensure smooth operations and compliance.
Conformity Testing and Labelling
- Ensure that required conformity testing is conducted.
- Ensure medical devices or IVDs are labelled correctly, with information provided in Vietnamese.
Ministry of Health Liaison
- Manage all communications with the Ministry of Health regarding your products.
- Coordinate and assist with scheduling manufacturing facility inspections when necessary.
Local Presence
Operate a local office in Vietnam with telephone and email connectivity to ensure continuous support.
Regulatory Monitoring
Monitor regulatory developments and alert you to any changes or new regulations that may affect your products.