Medical Device Importer of Record in Thailand
In Thailand, the role of Importer of Record (IOR) for medical devices is often misunderstood or intentionally simplified.
In reality, it is a non-delegable legal function that must be aligned with both regulatory authorization and fiscal responsibility.
Any structure in which the Importer of Record:
-
is different from the license holder,
-
operates independently from the Authorized Representative,
-
or acts merely as a logistics intermediary,
is structurally inconsistent with Thai FDA and customs regulations.
This article explains why the Importer of Record must be the same legal entity that holds the licenses and acts as Authorized Representative.
What “Importer of Record” Means Under Thai Law
Under Thai law, the Importer of Record is the entity that:
-
declares the goods to Thai Customs,
-
assumes legal responsibility for the imported products,
-
ensures compliance with applicable regulations at the border.
For medical devices, these obligations are inseparable from the medical device registration in Thailand.
Customs clearance is not a neutral administrative act: it is a regulated extension of market authorization.
Why the Importer of Record Must Be the License Holder
Thai FDA regulations establish a direct link between:
-
regulatory approval,
-
product responsibility,
-
and market accountability.
For this reason, the Importer of Record must be the same entity that:
-
holds the medical device licenses,
-
represents the manufacturer before Thai FDA,
-
manages post-market obligations.
This alignment is intrinsic to the role of the authorized representative for medical devices in Thailand.
Separating these roles creates regulatory gaps that cannot be justified under Thai law.
Customs Clearance and Regulatory Accountability
During importation, Thai authorities assess:
-
product classification,
-
license validity,
-
conformity with registered specifications.
If the Importer of Record is not the license holder:
-
accountability becomes fragmented,
-
corrective actions are delayed,
-
enforcement responsibility becomes unclear.
This is precisely why medical device license holder requirements in Thailand explicitly assume control over importation activities.
From a regulatory standpoint, one product must have one accountable legal subject.
Common Non-Compliant Importation Models
Despite regulatory clarity, non-compliant structures remain common, including:
-
third-party importers acting “on behalf of” license holders,
-
distributors importing under informal arrangements,
-
logistics companies used as nominal Importers of Record.
These models:
-
lack regulatory legitimacy,
-
fail substance-over-form assessments,
-
expose all parties to enforcement risk.
They are not regulatory shortcuts—they are compliance vulnerabilities.
Regulatory and Tax Risks of Using Third-Party Importers
Importation is not only a regulatory event, but also a taxable economic activity.
When third-party importers are used:
-
VAT attribution becomes inconsistent,
-
revenue flows no longer reflect the real business activity,
-
fiscal exposure increases significantly.
These risks escalate when importation is disconnected from Thai medical device post-market compliance obligations, such as vigilance, recalls, and field safety actions.
Aligning Importation With Post-Market Responsibilities
Post-market obligations require:
-
traceability,
-
rapid response capability,
-
direct regulatory communication.
Only an Importer of Record that is also the license holder and Authorized Representative can:
-
execute recalls,
-
manage adverse event reporting,
-
interact effectively with Thai FDA.
From a compliance perspective, importation is the first post-market act, not the last pre-market step.
Conclusion
In Thailand, the Importer of Record for medical devices cannot be treated as a separate or delegable role.
Regulatory consistency requires that:
-
the license holder,
-
the Authorized Representative,
-
and the Importer of Record
are the same legal entity.
Any deviation from this structure undermines regulatory accountability, fiscal compliance, and post-market control.
Manufacturers entering the Thai market should design their operating model around legal coherence, not around arrangements that may appear efficient but fail under regulatory scrutiny.
