Define the activities, not just the title
“Importer of record” is a commercial and customs term; it should not be assumed to confer medical-device import permission. An importer arranges or takes responsibility for the import transaction, while a distributor commonly manages onward commercial supply. A single entity may perform both roles, but each activity must be evaluated under local rules.
Regulatory permissions still matter
HSA identifies medical-device dealer licensing requirements for importing and wholesaling in Singapore. MDA describes establishment licensing under Malaysia’s Medical Device Act. Thai FDA’s guidance also identifies establishment requirements for commercial importers. A logistics contract alone does not replace the relevant local authorisation.
Allocate operational responsibilities
Our recommended responsibility matrix covers shipment documentation, customs coordination, product release, inventory ownership, customer orders, returns and safety communications. Confirm what the contracted entities actually provide and verify their permissions before shipping.
Official sources
HSA — Medical devices ↗MDA — Establishment License Information ↗Thai FDA — Manufacture / Import for Commercial Purposes ↗Sources accessed on 14 November 2026. Planning recommendations are identified in the text. Requirements may change; confirm the current position with the relevant authority.