THAILAND · MEDICAL DEVICES

Thailand Medical Device Transfer Guide: Thai FDA Transfer Conditions, Documents and Handover

A change of licence holder for medical devices in Thailand can, where the conditions are met, use the Thai FDA document transfer procedure (Transfer). A company cannot, however, rely on a new letter of authorisation alone to move a registration held by the original importer directly to another company. Transfer depends on the existing registration dossier, the original holder’s consent and the substantive consistency of the product before and after the transfer; approval of the new application also triggers cancellation of the original registration. The route should therefore be determined before the distribution agreement is terminated and before shipments by the new importer are arranged. (Source: Thai FDA Transfer procedure page, items 1–4)

What do Transfer and Refer each address?

This mechanism comes from the Thai FDA notification on referencing existing documents, transferring documents and other cases, published in the Royal Gazette on 19 September 2024, Volume 141, Special Part 260 Ngor, pages 10–13, and in force from the following day. The notification applies to applications for manufacturing or import licences and detailed notifications and, where the conditions are met, removes the need to send technical documents to the listed external persons, agencies or organisations for assessment. It remains an application procedure: it should not be read as exemption from applying, from review or as automatic approval, and it should not be applied indiscriminately to registrations for all device classes. (Source: Thai FDA official notification page)

For overseas manufacturers, the typical Transfer scenario is a change of the registered Thai import establishment from Company A to Company B. Refer, by contrast, is used to reference existing dossiers in order to apply for registration under a new brand name. Packaging a “change of holder” as a “change of brand” does not bypass the conditions that apply to each route.

The first two routes are set out in Clause 3(2) and Clause 3(1) of the notification respectively, and in the official Refer procedure page. The third row is a route-assessment recommendation, not a “transfer without consent” procedure provided for in the notification.

Why does Full CSDT determine whether a transfer can start?

The value of Transfer lies in using the existing registration dossier, which also explains why it requires the dossier basis to be checked first. If the original registration was submitted on a Partial basis under transitional arrangements, holding a valid certificate does not mean the Thai FDA has received the complete technical file. Clause 3(2), sub-item 2 of the notification requires that the documents previously exempted from submission be completed before the transfer proceeds. The official procedure page likewise requires the original holder to supplement the documents for Partial registrations. (Source: 2024 notification, Clause 3(2))

The practical review should compare the file kept at the manufacturer’s headquarters with the versions submitted, approved and subsequently changed in Thailand. A CSDT held at headquarters does not prove that the original Thai registration has become Full CSDT; the original agent’s assurance that “the dossier is complete” also needs to be tied to a specific registration number and document version. Otherwise, the missing evidence only surfaces when the new agent prepares the application, and the transfer timeline is then driven by supplementing documents rather than by how quickly the transfer form is submitted.

The Thai FDA already has a “document addition system” page covering cases such as Partial 1, Partial 2 and Abridged that need to be completed to Full CSDT, and it states that supplementing documents does not extend the validity of the original registration. Completing the dossier and renewal should therefore be planned separately; an expiring certificate must not be overlooked just because documents are being supplemented. The 2024 Transfer page still retains instructions on paper applications and USB submission, so for a specific transfer case the currently accepted channel for supplementary submissions should be confirmed rather than treating the procedures on an older page as permanent requirements. (Source: Thai FDA FAQ on supplementary documents and renewal)

The original holder’s cooperation is an explicit application condition

Whether the original holder is willing to hand over should be confirmed at project kick-off, not left until the other documents are ready. The Thai FDA’s official consent letter template, IVD-F-12, expressly requires the letterhead of the original import or manufacturing establishment licence holder, its consent to transfer the complete file for the specified device and registration number to the receiving company, and signature and company seal by a senior officer of the company. The template also includes an acknowledgement of the cancellation of the original registration and the submission of the related documents within 30 calendar days. (Source: Official consent-to-transfer letter template, published 4 Oct 2024)

This means that a letter of authorisation from the product owner appointing a new importer cannot replace the original holder’s consent letter. If the original holder refuses to sign, the standard Transfer route will lack a required document. The manufacturer can pursue negotiations under the handover clauses of its contract while explaining the registration status, authorisation relationships and the availability of the dossier to the Thai FDA and assessing an independent application; but it should not promise the commercial team that “withdrawing the old authorisation will force a transfer”. Obtaining the new registration and dealing with the old registration are matters that need to be confirmed separately.

Which facts need to be verified behind the declaration of consistency?

For imported devices, a transfer requires that the product’s trade name, model, product code, indications, intended use and key technical characteristics remain the same, and that the manufacturing site and product owner are unchanged; the product licence or detailed notification to be transferred must be valid, not expired, not revoked and not suspended. If a change of factory, an expanded intended use or additional models are planned alongside the change of holder, the changes should first be separated to determine which need to be handled separately; a single commercial “handover” should not be treated as a single regulatory Transfer. (Source: 2024 notification, Clause 3(2), sub-items 5–7)

The documents should be organised around these facts. The declaration of conformity and the import authorisation letter relating to the new entity must correspond to each other; the remaining documents submitted under the regulations must be consistent with the file being transferred and certified accordingly. A declaration of consistency, a consent-to-transfer letter and a safety declaration are also required, and the remarks field of the electronic application should state Transfer and the original licence or detailed notification number. The official procedure requires the three dedicated documents to be merged and uploaded under “Other attachments 1”. (Source: Thai FDA Transfer procedure page, items 2 and 3)

The safety declaration should not be treated as a mere signature attachment either. Clause 4 of the notification excludes cases with a history of serious adverse events, device defects that could cause serious adverse effects, or reasonable grounds to doubt quality, performance and safety. Companies should first check complaint, recall and safety corrective action records and, where issues are found, assess whether the route still applies, rather than using a change of company name to skip existing risks. (Source: 2024 notification, Clause 4)

What do the 30 days after approval mean?

Item 4 of the official Transfer procedure states that once the new application is approved, the original registration file will be cancelled and the original holder must complete the submission of the related termination documents within 30 calendar days from the approval date. This is a post-approval filing obligation; it is neither the review timeline for the transfer nor a grace period allowing continued imports under the original certificate. (Source: Thai FDA Transfer procedure page, item 4)

The E-SUB-21.pdf linked from that page is a procedure guide for cancellation and non-renewal, not a statutory form named “E-SUB-21”. Its early cancellation section lists documents such as the cancellation request letter, the declaration of remaining device quantities and storage locations (ล.พ.1), and the original licence or detailed notification. The termination formalities referred to in this article should therefore be applied to the specific licence or notification being transferred; it cannot be inferred that the original company must close its entire business or cancel all of its establishment qualifications. (Source: Thai FDA E-SUB-21 procedure guide, pages 1–4)

The approval date should become the control point for the supply chain switch. Goods awaiting customs clearance, stock in the original holder’s warehouse and devices already delivered to hospitals are not in the same regulatory and contractual position. Before submission, clarify the importing entity, storage location and onward sales arrangements for each batch, and obtain case-specific confirmation of the applicable treatment of stock after cancellation. It cannot be assumed that goods already imported may be sold indefinitely, nor should the 30-day document filing period be equated with a uniform sell-off period for stock.

A handover scenario: why coordinate in advance?

The following is an illustrative scenario and does not represent an actual client case. A manufacturer plans to move a device from importer A to importer B. The two sides have agreed commercial terms, but A’s registration was filed with a Partial dossier, and a hospital has a further batch of orders awaiting delivery. If the switch-over plan is built solely around the timing of B’s electronic submission, the project will miss the work of A completing the file, signing the consent letter and dealing with remaining stock after approval.

A sounder arrangement is to confirm the dossier gaps and the time needed to close them first, then negotiate the application and supply windows, while making clear who handles complaints on historical batches, who retains traceability records and who is responsible for continuity of hospital-side service. A transfer of registration resolves the regulatory applicant and the takeover of the file; it does not automatically complete the sale of stock, the termination of the distribution agreement, warranty commitments or the handover of records. Even after the new registration is approved, these unresolved items can still affect hospital use and subsequent risk handling.

Where a Thai licence holder independent of the distributor is needed, see MediPass’s Thailand local licence holding and transfer takeover services.