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Your product is registered in Thailand, and now you want to tweak the design, switch a material or add a few models. All of these changes first need approval from the Thai FDA. Until now this step could take two to three months and cost an extra expert-review fee.
There is now a “fast track”: if the same change has already been approved in a reference country such as the US or the EU, Thailand can approve it in as little as 15 working days, without any external expert review.
1. What counts as a “change”?
A medical device registration is not a one-off. After registration, any change to the product information, such as a design change, a new supplier, updated labelling or instructions, or new models or accessories, must be submitted to the local regulator as a change application. You may only sell under the new information once it is approved.
Thailand sorts changes into three tiers by impact:
- Automatic approval: administrative changes such as updating a certificate or removing models. The system approves them directly.
- Minor change: little effect on safety and performance, for example a small change in appearance.
- Major change: may affect safety, performance or intended use, for example a design change or a new critical material.
The last two tiers both need Thai FDA review, and complex cases may be sent to external experts, which adds time and cost. The new fast track targets exactly these two tiers.
2. How much faster is the fast track?
| Standard route | Fast track (approved in a reference country) | |
|---|---|---|
| Review time | 15–85 working days; the more you change at once, the longer it takes | 15 working days (35 working days if more than 10 new models are added at once) |
| External expert review | May be required | Not required |
| Official fees | About THB 20,000–30,000 when sent to experts | THB 500 application fee |
| Requests for additional information | Yes | Once, with a reply due within 5 working days |
In short: the fast track is faster and cheaper, and bundling several changes into one application does not make it take longer.
3. Can my product use the fast track?
Yes, if all three conditions are met:
- The product is a Thai Class 2–4 medical device (low-risk Class 1 products are not covered).
- The change needs Thai FDA review, i.e. it is a minor or major change.
- The same change has been approved in a reference country. According to industry sources, the reference countries include the US, the EU, Canada, Australia and Japan, as well as Singapore and Malaysia. The list published by the Thai FDA prevails.
Note: if the product’s risk class changes, or the registration is to be transferred to another company, this is not a change but requires a new registration.
4. Key dates
- Announced: according to industry reports, the Thai FDA introduced the new review timelines on 21 October 2026.
- Effective: no separate effective date has been published. Our current understanding is that applications can be filed from the announcement; actual acceptance by the Thai FDA prevails.
- Deadline: none. This is a measure to speed things up, not a new mandatory requirement. Companies can use it whenever it suits their change plans.
5. Four recommendations for companies
1. Get approval abroad first, then file in Thailand. When planning a product change, complete it in markets such as the EU or US first, then apply in Thailand with the approval documents to use the fast track.
2. Products with only a Chinese registration cannot use it for now. China is not among the reference countries published so far. These products still go through the standard route, so we recommend filing changes in batches rather than bundling too many into one application, to avoid longer review times.
3. Prepare documents in advance and respond quickly. The fast track allows only one request for additional information with a 5-working-day reply window. Prepare a before-and-after comparison of the change, old and new labels, and an English technical description in advance.
4. Plan ahead if you need the full registration route. Changes that cannot use the fast track, and cases that need a new registration (such as a change in risk class or a transfer to another licence holder), take longer and may be sent to external experts. Plan your submissions early and allow enough time for review so that sales in Thailand are not disrupted. EVERBIZ can help you plan your registration route and timeline.
How EVERBIZ can help
EVERBIZ holds a Thai medical device import establishment licence and can act as your local licence holder in Thailand. We can help you classify the change, assess whether the fast track applies, and handle the online submission and replies to requests for additional information. To find out whether your product qualifies, please contact us.