The Thai Food and Drug Administration (Thai FDA) has published an infographic outlining the Change Notification System for Class 2–4 medical devices.
The update explains how changes are categorized, the applicable processing timelines, correction periods, and government and expert assessment fees. Processing requirements differ depending on whether the proposed change has already been approved by a reference country, the number and type of changes submitted, and whether external expert review is required.
Read the full update here:
https://medical.fda.moph.go.th/press-release/change-notification-system/
(Thai FDA official website. Information is provided in Thai.)
Levels of Change
Changes are divided into three categories:
Major and Minor Changes
Major and Minor changes require technical document assessment by a Thai FDA officer or external expert before approval.
Auto Approve
Certain eligible changes may be automatically approved through the system without further assessment.
Processing Time and Review Conditions
Approved Change Received from a Reference Country
| Case | Change Topic in Application | Processing Time Without Expert | Processing Time With Expert | Correction Rounds | Time Given for Correction |
|---|---|---|---|---|---|
| 1 | Adding items to the medical device list, up to 10 items; or other Major and Minor changes | 15 working days | – | 1 | 5 working days |
| 2 | Adding items to the medical device list, more than 10 items | 35 working days | – | 1 | 5 working days |
For this condition, “adding items to the medical device list” includes:
- Adding a medical device item – Major
- Adding a medical device item with the same design – Major
- Adding a medical device item or software that does not affect performance characteristics or product specifications – Minor
- Adding accessory items to the main medical device – Minor
Approved Change NOT Received from a Reference Country
| Case | Change Topic in Application | Review Type | Processing Time | Correction Rounds by Officer | Correction Rounds by Expert | Time Given by Officer | Time Given by Expert |
|---|---|---|---|---|---|---|---|
| 1 | Auto Approve: 1 topic or more, provided the application contains only Auto Approve topics | Automatic | Immediate | – | – | – | – |
| 2 | Major: 1 topic, or Minor: 1–3 topics | Without expert | 15 working days | 1 | – | 5 days | – |
| 2 | Major: 1 topic, or Minor: 1–3 topics | With expert | 30 working days | 1 | 1 | 5 days | 5 days |
| 3 | Major: 2–3 topics, or Minor: 4–9 topics | Without expert | 35 working days | 1 | – | 10 days | – |
| 3 | Major: 2–3 topics, or Minor: 4–9 topics | With expert | 55 working days | 1 | 1 | 10 days | 10 days |
| 4 | Major: 4–5 topics, or Minor: 10–15 topics | Without expert | 50 working days | 1 | – | 10 days | – |
| 4 | Major: 4–5 topics, or Minor: 10–15 topics | With expert | 70 working days | 1 | 1 | 10 days | 10 days |
| 5 | Major: 5+ topics, or Minor: 16+ topics | Without expert | 65 working days | 1 | – | 10 days | – |
| 5 | Major: 5+ topics, or Minor: 16+ topics | With expert | 85 working days | 1 | 1 | 10 days | 10 days |
Examples provided by Thai FDA include:
- Case 3: Minor 5 topics; or Minor 3 topics + Major 1 topic
- Case 4: Minor 11 topics; or Minor 3 topics + Major 3 topics
- Case 5: Minor 17 topics; or Minor 3 topics + Major 4 topics
For Cases 2–5, Thai FDA applies the equivalence of:
3 Minor changes = 1 Major change
Fees
| Category | Application Fee | Expert Document Assessment Fee | Total With Expert |
|---|---|---|---|
| Notified Certificate of Manufacturing – Class 2–3 | THB 500 | THB 19,200 | THB 19,700 |
| Notified Certificate of Importation – Class 2–3 | THB 500 | THB 24,000 | THB 24,500 |
| Manufacturing License – Class 4 | THB 500 | THB 24,000 | THB 24,500 |
| Import License – Class 4 | THB 500 | THB 30,000 | THB 30,500 |
If expert review is not required, only the THB 500 application fee applies.
Implications to Clients
Any proposed change to a registered Class 2–4 medical device should be submitted for regulatory assessment before implementation.
The applicable processing timeline and fees will depend on:
- Whether the change has already been approved by a reference country
- Whether the change is classified as Major, Minor, or Auto Approve
- The number of changes included in the application
- Whether external expert review is required
Clients should also consider the impact of combining multiple changes within a single application, as a higher number of changes may significantly extend the review timeline, particularly where expert assessment is required.
Effective Date
Effective from August 14, 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.