Authorized Representative for Medical Devices in Thailand
The Legal Role of the Authorized Representative Under Thai FDA Rules
In the Thai medical device regulatory framework, the Authorized Representative (AR) is not a formal placeholder.
It is the legal and fiscal cornerstone of market access.
Any structure where the Authorized Representative:
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does not hold the licenses,
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does not import the products,
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does not receive payments locally,
is non-compliant with Thai regulatory and tax law, regardless of how common or “convenient” it may appear in practice.
Understanding this point is essential to avoid regulatory exposure, tax violations, and operational risk.
Authorized Representative ≠ Nominee Entity
Under Thai FDA regulations, the Authorized Representative must be a Thai legal entity that:
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holds the medical device licenses
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acts as importer of record
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manages customs clearance
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interfaces with Thai FDA on post-market obligations
This role is inseparable from the broader medical device registration in Thailand process.
Any attempt to split these responsibilities across multiple entities creates regulatory fragmentation and liability gaps.
Importation and Customs: One Legal Subject Only
Thai customs law is explicit:
the entity importing medical devices must be the same legal subject that holds the relevant regulatory approvals.
This means:
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the Authorized Representative must be the importer
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third-party importation schemes are structurally non-compliant
For a technical breakdown of importer obligations, see medical device importation compliance in Thailand.
If importation is handled by an entity other than the license holder, both parties are exposed.
Payments, VAT, and Thai Tax Law
This is where many structures collapse.
Core principle:
If the business activity takes place in Thailand, payment must be made in Thailand.
Under Thai tax law:
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sales of medical devices in Thailand are subject to VAT
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VAT liability arises where the economic activity occurs
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payment flows must reflect the actual business reality
Therefore:
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the Authorized Representative receives payment from the Thai distributor
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VAT is applied and accounted for in Thailand
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funds are then remitted to the manufacturer under compliant agreements
Any model where:
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distributors pay offshore
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license holders act only as “paper entities”
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funds bypass Thailand
is fiscally non-compliant and exposes all parties to enforcement risk.
Why “Alternative Structures” Are High Risk
Structures often proposed as “optimizations” typically include:
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offshore invoicing
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split payment arrangements
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non-Thai entities receiving Thai revenues
These models:
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contradict Thai VAT principles
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fail economic substance tests
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expose manufacturers to retroactive tax claims
As detailed in Thai medical device regulatory obligations post-market, regulatory compliance does not end with licensing.
Risk Assessment: Choosing the Right Authorized Representative
Manufacturers should not evaluate an Authorized Representative based on price, but on risk containment.
Key criteria include:
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corporate substance in Thailand
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import and customs capability
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VAT compliance and accounting transparency
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ability to support audits and inspections
For technical criteria, refer to medical device license holder requirements in Thailand.
Conclusion
In Thailand:
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the Authorized Representative is the license holder
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the license holder is the importer
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the importer is the recipient of payments
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payments are taxed in Thailand
Any deviation from this structure is not a creative solution—it is a compliance risk.
Manufacturers entering the Thai market should design their model around regulatory and fiscal reality, not around shortcuts that may work elsewhere but fail under Thai law.
