Why Distributor-Held Registrations Are Risky in Thailand

Q: If you hand the certificate to a distributor in Thailand, what is the worst that can happen?

1. Key takeaways

Handing your Thai registration certificate to a distributor creates four classes of consequences, ranked here by how often they occur. First, changing distributors requires a certificate Transfer, and the transfer cannot proceed unless the original licence holder issues a written letter of consent. Second, when the transfer cannot be completed, the fallback is a brand-new registration: fees paid again, months or even a year of waiting, and potentially a stricter review against updated standards. Third, the full CSDT technology dossier ends up in the distributor’s hands and is hard to recover after the relationship terminates. Fourth, the distributor ends up controlling both the certificate and the channel, leaving the original manufacturer without a voice on price, inventory or service. Every one of these consequences stems from a single structural fact: the registration certificate is the market access asset, and whoever holds it controls the product in Thailand.

• Channel changes touch the certificate. Switching distributors requires a Transfer, and the prerequisite is a written Letter of Consent from the original licence holder; without the counterpartys cooperation the transfer simply cannot be done.
• Re-registration is the expensive fallback. A brand-new application means paying again (Class 4 import 74,000 THB), waiting months or even a year, and possibly facing a stricter review under the current standards.
• The technology dossier leaks. The complete CSDT dossier, including design, process, verification data and risk analysis, stays with the distributor and is difficult to recover after the cooperation ends.
• Channels become locked. With the certificate and the channel in the same hands, the manufacturer loses bargaining power on price, inventory and service.
• The consent letter cannot be forced. It is a document the counterpart voluntarily issues, so control over switching distributors effectively sits with the counterpart.
• Prevention beats remedy. Not handing over the certificate in the first place, via an independent licence holder, is ranked the most effective of the three risk-reduction measures.

2. Legal basis

The transfer rules come from the Thai FDA transfer notice dated 2024-09-19, effective 2024-09-20, which sets out five prerequisites for a certificate transfer. The application must be based on a Full CSDT dossier; if the original certificate was granted on a Partial dossier, it must first be completed to Full. The original licence holder must issue a written consent letter. A declaration of sameness and a safety declaration must be provided. The transfer must involve the same manufacturer and the same product owner. And the original certificate must be valid. Beyond these five prerequisites, the notice excludes from transfer any device with a history of serious adverse events, or any device for which there are reasonable doubts about its quality, efficacy or safety. Certificates granted through the simplified paths, Abridged or Reliance, must have their dossiers completed to full before a transfer can proceed. The cost of the fallback route is anchored in the Thai FDA fee schedule, where re-registering a Class 4 imported device costs 74,000 THB, and the review timeline cap for Class 4 is 300 days.

3. Expert insights

The critical risk sits in the second prerequisite, the consent letter. Because the letter is a document the original licence holder issues voluntarily, it is legally difficult to compel, which means the initiative over changing distributors effectively rests with the counterpart. This is what turns an apparently minor administrative detail into a strategic exposure. The practical judgement is blunt: registration certificate control should be written into the decision checklist for a new market entry as the very first item. At signing time this decision costs almost nothing, but when a relationship breaks down the price is months of cycle time plus the full registration fees plus a possible interruption of supply. Among the decisions involved in Thailand market access, this is the only one where choosing wrongly cannot be corrected at low cost. A technical dossier written incorrectly can be amended and supplemented; a licence holder chosen wrongly means starting over. That asymmetry, a cheap decision today versus an unrepeatable process tomorrow, is why experienced market entrants treat certificate ownership as a structural question rather than a commercial detail, and why they settle it before any distributor agreement is signed rather than after the first dispute.

4. Practical recommendations

• Do not hand the certificate to the distributor in the first place. Use the independent licence holder (ILH) model to eliminate the risk structurally; this is the most effective of the three mitigation measures.
• If distributor-held is chosen, pre-agree in the contract. Write into the cooperation agreement that upon termination of the cooperation, the licence-holding party must issue, within X working days, the written consent letter and related documents required for the transfer. This cannot guarantee cooperation, but it provides the basis for a legal claim.
• Keep a dossier backup. The full CSDT should be retained by the original manufacturer, with only the version necessary for the filing provided to the licence holder, reducing the scope of any leak.
• If the certificate is already with a distributor, assess three paths. Negotiated transfer is lowest cost but depends on the counterpart; re-registration is costly but controllable, because the pace is in your own hands; maintaining the status quo is viable only when the channel relationship is stable and there are no expansion plans, while the exposure persists.
• Make the decision on a three-year horizon. Use the question of whether channels will be changed or added in the next three years as the decision basis for choosing among the three paths.
• Treat certificate control as decision number one. Put registration certificate control at the top of the market-entry decision checklist, because it is the one choice in Thailand that cannot be corrected cheaply later.

5. Verification checklist

• □ Thai FDA transfer notice (2024-09-19, effective 2024-09-20) and its five prerequisites
• □ Requirement of a written Letter of Consent from the original licence holder
• □ Situations where transfer is refused (history of serious adverse events; doubts over quality, efficacy or safety)
• □ Simplified paths (Abridged / Reliance) requiring completion of the full dossier before certificate transfer
• □ Thai FDA fee schedule (re-registration cost: Class 4 import 74,000 THB)
• □ Thai FDA review time limit cap (Class 4, 300 days)

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