To mitigate the impact of the crisis situation in the Middle East and support manufacturers and importers of medical devices affected by disruptions in the supply chain of raw materials, packaging, or finished products, the Thai FDA has introduced a Fast Track channel for specific medical device change submissions.
This initiative aims to facilitate faster processing of change notification submissions for medical device products and manufacturing establishments to help ensure continuous patient access to essential medical devices.
Read the full infographic here: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
Purpose of the Measure
To mitigate the impact of the crisis situation in the Middle East on the supply chain of medical devices.
To support medical device manufacturers and importers affected by disruptions in raw materials, packaging, or finished products.
To facilitate faster processing of eligible change notification submissions and help ensure continuous patient access to essential medical devices.
Scope of Application
This Fast Track measure applies to specific medical device change submissions for medical device products and manufacturing establishments affected by supply chain disruptions.
Priority is given to eligible Watch List products and qualifying amendment types.
Fast Track Measures
The Fast Track mechanism offers the following benefits:
- Review period of only 5 working days
- Priority given to Watch List products
Watch List Products
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Processing Time Comparison
Amendment Type | Normal (working days) | Fast Track (working days) |
Items in License / Notification / Listing | 15 days | 5 days |
Establishment registration certificate | 30 days | 5 days |
Not Eligible for Fast Track
The following changes are excluded from the Fast Track measure:
- Amendment of indication
- Change of manufacturing site
Focused Review Scope
Thai FDA officers will focus only on the key documents necessary to assess the safety and efficacy of the medical device, allowing for accelerated review timelines.
Implications to Clients
Change requests that normally take 15 to 30 working days may now be completed within only 5 working days, significantly reducing processing timelines.
However, stakeholders should carefully assess whether their submission qualifies under the Fast Track criteria, particularly regarding eligibility of the product under the Watch List and the type of amendment being submitted.
Submissions that do not meet the qualifying conditions will continue to follow the standard review timeline.
Effective Date
Currently effective
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.