Local Authorised Representative in Thailand
Entering Thailand’s medical device market can be complex, especially when managing local regulations from abroad. That’s where Andaman Medical comes in.
As a trusted Local Authorised Representative (LAR) in Thailand, we offer the regulatory expertise and in-country support you need for smooth market entry and continued compliance. From submission to post-market activities, we manage the details so you can focus on delivering innovative medical solutions to healthcare providers and patients across Thailand.
Andaman Medical has been serving as a Local Authorised Representative in Thailand since 2017.
Why Get Local Authorised Representation in Thailand
Appointing a Local Authorised Representative (LAR) in Thailand isn’t just a regulatory formality—it’s key to ensuring smooth market access and sustained compliance in a highly regulated healthcare landscape.
At Andaman Medical, we provide professional LAR services tailored to Thailand’s regulatory environment. Acting as your in-country representative, we ensure full Thai FDA compliance, manage all local communications, and oversee post-market obligations.
Here’s why having a Local Authorised Representative (LAR) in Thailand is essential:
Streamlined Registration Process
Streamlined Registration Process
A LAR has the local expertise and understanding of regulatory procedures, helping to navigate complex documentation and submission requirements. This streamlines the registration process, reducing the risk of delays and rejections.
Regulatory Compliance
Regulatory Compliance
A LAR ensures that all requirements set by Thailand’s Food and Drug Administration (Thai FDA) are met, helping companies stay compliant with current regulations and avoid penalties or product recalls.
Efficient Communication with Authorities
Efficient Communication with Authorities
LARs act as a direct communication link between the company and Thai regulatory bodies, effectively addressing any questions, requests for additional information, or changes in requirements.
Up-to-Date Knowledge of Regulatory Changes
Up-to-Date Knowledge of Regulatory Changes
LARs keep companies informed about the latest regulatory updates and policy changes in Thailand, ensuring ongoing compliance and helping to adapt strategies quickly when needed.
Faster Market Access
Faster Market Access
With the local knowledge and established relationships with regulators, a LAR can expedite the approval process, allowing faster entry into the Thai market and enabling companies to start selling their medical devices sooner.
Local Representation for Product Issues
Local Representation for Product Issues
A LAR is responsible for handling post-market surveillance, adverse event reporting, and product recalls, providing a local point of contact for regulatory authorities, which is crucial for ongoing market access.
What You Need to Know About Having a
Local Authorised Representative in Thailand
Establishment Licence
- The in-country representative must have an Establishment License for importing medical devices, issued by the Thai FDA.
- Only individuals of Thai nationality or locally established companies can apply for this licence.
- This licence, along with a Letter of Authorization (LoA), allows the in-country representative to register the medical device.
Multiple Representatives
- Yes, multiple in-country representatives are allowed in Thailand.
- All LARs must individually register the device. Each registration is treated as a new application, and registration fees apply each time.
Device Registration
Once the medical device is registered, notified, or validated, the Thai FDA will issue a Listing Certificate, Notification Certificate, or License, as applicable.
Letter of Authorization (LoA)(Issuance)
- The foreign manufacturer must issue a Letter of Authorization (LoA) on company letterhead, signed and stamped by an officer of the company owning the product.
- The LoA does not have a fixed duration.
Why Choose Andaman Medical for Your In-Country Representation in Thailand?
Local Expertise
Our team of RA specialists is based in the key ASEAN markets we serve; Indonesia, Malaysia, Vietnam, Thailand, Philippines, Singapore, and Cambodia
Proven Track Record
We've registered 1000+ medical devices and IVDs across Southeast Asia.
In-House Team
We don't outsource - you get reliable, consistent support from our own staff.
Contact Us
We meet the highest quality standards as a medical device company ourselves.
Flexible and Independent
Tailored services to meet your needs while you keep control of your product.
