Transfer and Refer of Thai Medical Device Registrations: Rules and Strategy

Can a Thai registration certificate be transferred? Yes. Under the announcement of September 19, 2024 (effective September 20, 2024), Thailand established a unified transfer process for Classes 2-4. Before that, transfers lacked uniform rules and were difficult in practice; the new rules clarified the pathway and the conditions.

1. Key takeaways

Transfer and Refer are two distinct actions that are constantly confused, and the conditions and consequences of each matter directly to how licence holding should be structured. The essentials follow.

• Transfer is used to change the licence holder — moving the registration certificate from one Thai entity to another.
• Refer is used to change the brand name.
• Both actions share two preconditions: both require a Full CSDT dossier, and both require the consent letter of the original licence holder.
• Five conditions apply to a Transfer: the dossier must be Full CSDT (a Partial dossier must first be completed to Full); the original licence holder must issue a written Letter of Consent; a Declaration of Identicality and a Safety Declaration must be submitted; the devices before and after the transfer must come from the same manufacturer and the same Product Owner; and the original certificate must be valid.
• Process: submission via e-Submission; the Thai FDA aims to complete within about 2 months; upon approval a new registration number is issued, and the original holder must cancel the original certificate within 30 days.
• Transfers are refused where the device has a history of serious adverse events, or where there are reasonable doubts about its quality, performance or safety.
• Certificates obtained through Reliance or the Abridged simplified routes must be supplemented with a complete dossier when transferred — pathway selection should leave room for possible future transfers.
• The structural lesson: because transfer requires the original holder’s written consent, if the certificate sits with a distributor and the relationship breaks down, the manufacturer may be forced to file an entirely new registration, paying fees again and waiting months or even a year, possibly under stricter current standards. This is the institutional reason behind the advice not to hand the certificate to a distributor (see article 33).

2. Legal basis

The unified transfer framework derives from the Thai FDA transfer announcement of September 19, 2024, effective September 20, 2024, covering Classes 2-4. The five preconditions, the process parameters and the refusal grounds all rest on this announcement: a Full CSDT dossier (with Partial dossiers first completed to Full); the original holder’s Letter of Consent; the Declaration of Identicality and the Safety Declaration; identity of manufacturer and Product Owner before and after transfer; and a valid original certificate. Processing runs through e-Submission with completion targeted at about 2 months; a new registration number issues on approval and the original holder cancels the original certificate within 30 days. Refusal applies where a serious adverse event history exists or where reasonable doubts about quality, performance or safety remain. The distinction between the two actions is summarised below.

3. Expert insights

The implications for licence-holding strategy are extremely important. Because a transfer requires the original licence holder’s written consent, the configuration of the certificate is a matter of corporate control, not administrative convenience. If the certificate is held in the distributor’s name and the commercial relationship collapses, and the distributor declines to cooperate in issuing the consent letter, the manufacturer is generally left with only one option: filing a brand-new registration application — paying the official fees again, waiting months or even a year, and possibly facing review against stricter current standards. This is precisely the institutional reason behind the rule of thumb that the certificate should not be handed to the distributor (see article 33 for detail).

A second, related insight: certificates registered through the Reliance or Abridged simplified routes must be supplemented with a complete dossier at the time of transfer. A company that saved time at registration through a simplified route should therefore assume that any future change of licence holder will first require building out the full file. Pathway selection and licence-holding structure are not independent decisions; they interact, and both should be planned with the end state in mind.

4. Practical recommendations

• Agree the consent-letter obligation in advance in the cooperation agreement. Even where a distributor holds the certificate, the agreement should state that upon termination of the cooperation, the certificate holder must issue the written consent letter and related documents required for transfer within a defined number of working days.
• Such a clause cannot guarantee cooperation, but it provides the legal basis for a claim in a dispute — without it, there is not even a basis to assert.
• Prefer holding structures that keep the certificate with the manufacturer or a controlled entity, given the leverage the consent requirement gives whoever holds the certificate.
• If a Partial-route certificate may be transferred in future, plan the completion to Full CSDT early, since the transfer cannot proceed until the dossier is complete.
• Confirm before filing that manufacturer and Product Owner will remain identical across the transfer, since identity is a stated precondition.
• For certificates originally registered via Reliance or Abridged, budget the full-dossier supplementation as part of any transfer plan.
• Remember the post-approval mechanics: new registration number on approval, and cancellation of the original certificate by the original holder within 30 days.

5. Verification checklist

• □ Thai FDA transfer announcement (September 19, 2024, effective September 20, 2024): unified transfer process for Classes 2-4
• □ Five transfer preconditions (Full CSDT, original holder consent letter, Declaration of Identicality and Safety Declaration, same manufacturer and Product Owner, valid original certificate)
• □ Process: e-Submission, completion in about 2 months, new registration number issued, original holder cancels the original certificate within 30 days
• □ Refusal grounds (serious adverse event history; doubts about quality, performance or safety)
• □ Distinction between Transfer (change of licence holder) and Refer (change of brand name)
• □ Rule that certificates from simplified routes must be supplemented with a complete dossier upon transfer

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Thailand. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the Thai FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com