The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA) has introduced an updated regulatory framework for medical device change notification, applicable to notified and licensed medical devices (Risk Classes 2-4). Under this updated framework, modification requests are categorized into Auto-Approve, Minor, and Major changes based on technical complexity and risk impact.
The updated framework establishes revised evaluation criteria, processing timelines, and applicable fees for each change category. These changes are intended to streamline the change notification process while ensuring that modifications to medical devices are appropriately evaluated.
Level of Change Notification
Change notification are categorized into the following levels based on review requirements:
- MAJOR & MINOR CHANGE: Modifications that require technical document evaluation by The Thai FDA official reviewers or external experts prior to approval.
- AUTO APPROVE: Modifications that are automatically approved by the system.
Evaluation Timelines and Conditions
In Case the Change Has Been Approved by One of the Reference Countries
| Condition | Amendment topics in application | Process timeline (working days) Without Expert |
Process timeline (working days) With Expert |
Compliance Rounds Allowed | Compliance Period (working days) |
| 1 | 1. Addition of medical device: Up to 10 models 2. Other amendment topics (Major and Minor) |
15 | - | 1 | 5 |
| 2 | Addition of medical device: 10 models or more | 35 | - | 1 | 5 |
Note: Addition of medical device topics includes:
- Addition of medical device models (Major)
- Addition of medical device with the same design (Major)
- Addition of medical device or software that do not affect performance characteristics and product specifications (Minor)
- Addition of accessories of the main medical device (Minor)
In Case the Change Is Not Approved by the Reference Country
| Condition | Amendment items in application | Scenario | Process timeline (working days) | Compliance Rounds Allowed Officer |
Compliance Rounds Allowed Expert |
Compliance Period (working days) Officer |
Compliance Period (working days) Expert |
| 1 | Auto approve: 1 or more topics (Immediate system approval). Condition: The application must include only Auto-Approve topics. | - | - | - | - | - | - |
| 2 | Major: 1 topic or Minor: 1-3 topics |
Without Expert | 15 | 1 | - | 5 | - |
| With Expert | 30 | 1 | 1 | 5 | 5 | ||
| 3 |
Major: 2-3 topics or
|
Without Expert | 35 | 1 | - | 10 | - |
| With Expert | 55 | 1 | 1 | 10 | 10 | ||
| 4 |
Major: 4-5 topics or
|
Without Expert | 50 | 1 | - | 10 | - |
| With Expert | 70 | 1 | 1 | 10 | 10 | ||
| 5 |
Major: ≥ 5 topics or
|
Without Expert | 65 | 1 | - | 10 | - |
| With Expert | 85 | 1 | 1 | 10 | 10 |
Note: 3 Minor Change topics are equivalent to 1 Major Change topic (3 Minors = 1 Major).
Fees
Evaluation Fees for Medical Device Change Notification (Currency: THB)
| Category | Application fee | Evaluation Fee for Expert Review (if any) | Total (THB) |
| Notified medical devices (Class 2 to 3) | |||
| Manufacturing | 500 | 19,200 | 19,700 |
| Importation | 500 | 24,000 | 24,500 |
| Licensed medical devices (Class 4) | |||
| Manufacturing | 500 | 24,000 | 24,500 |
| Importation | 500 | 30,000 | 30,500 |
Note: In cases where experts review is not required, only the 500THB application fee applies.
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Reference
Preparing for the New Medical Device Change Notification System Prior to Implementation