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?
- 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.
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