Local authorised representative in Thailand
The Food and Drug Administration (FDA) or medical device authority in Thailand 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 Thailand since 2017.
What are the requirements for a marketing authorization holder or LAR in Thailand?
- While there are no specific legal requirements in order to become a local authorized representative in Thailand, there are legal requirements for registering and importing medical devices into Thailand, which are in essence the functions of a LAR
- An in-country representative must have an Establishment License for the importation of the medical device issued by the Thai FDA (only people of Thai nationality or local established companies can apply)
- This Establishment License together with the Letter of Authorization (see below) will allow an in-country representative to register the medical device
- Once the medical device has been registered, notified, or validated, the Thai FDA will issue a Listing Certificate, Notification Certificate or License which ever is applicable for the product.
Can you appoint multiple marketing authorization holders in Thailand?
- Yes, multiple in-country representatives are allowed in Thailand 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) on company letterhead, signed and stamped by an officer of the company owning the product
- The LoA has no fixed duration.
How Andaman Medical can help with in-country representation in Thailand:
As your marketing authorization holder or local authorized representative in Thailand we will:
- represent your company in all dealings with the Thai FDA and other authorities responsible for medical devices and in-vitro diagnostics including:
- registering your product
- importing your product
- ensuring post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Effects (commonly known as Adverse Events) and Field Safety Corrective Actions
- Ensure that the medical device or IVD is correctly labelled and that information is provided in the Thai for home use medical devices
- Accept all calls from the Thai FDA regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer
- Maintain our office including a telephone and email connection in Thailand
- Assist with complaint handling
- Monitor regulations to alert you to any changes or new regulations applicable to your product.