Thai FDA amended their timing for Medical Device Registration, by shortening the process in some cases.
After the new Medical Device Act, issued in 2021 (see our article HERE), Thai FDA introduced the concept of Partial registration (partial 1 – partial 2) versus Complete registration. Most of devices can access the Partial 2 procedure.
With the new Medical Device Act timing was slightly increased, now Thai FDA is trying to reduce timing for Medical Device Registration as indicated in below table.
Timing for Thai FDA Medical Device Approval
Medical Device Class |
Max Review Time (Working days) |
| Class 1. Listing Medical Device | |
| Registration for importation of Listing medical devices not sterile and not for measurements |
7 |
| Registration for importation of sterile and measurement Listing medical devices |
200 |
| Class 2. Notified Medical Device
Class 3. Notified Medical Device |
|
| Registration for importation of Notified medical devices in Partial 2 process |
150 |
| Registration for importation of Notified medical devices in Full CSDT process |
200 |
| Registration for manufacturing or importation of Notified medical devices with Full CSDT with Specialist Review (e.g. innovative Medical Devices) |
250 |
| Class 4. Licensed Medical Device | |
| Registration for importation of Licensed medical devices in Partial 2 process |
200 |
| Registration for importation of Licensed medical devices in Full CSDT process |
250 |
| Registration for importation of Licensed medical devices in Full CSDT with Specialist Review (e.g. innovative medical devices |
300 |
Timing for Thai FDA Medical Device Registration is calculated from the moment of payment for dossier submission for FDA evaluation. Dossier preparation time is not included.
Is Thai FDA faster than other Regulators?
Compared to other Countries the Time for Medical Device approval in Thailand is shorter: China FDA takes 14-16 months for a class 2; US FDA 510k process is from 9 to 36 months for a class 3.
Medical Device dossier preparation in CSDT or partial 2 is a very sensitive process
Even if your Medical Device has been approved in other ASEAN Country with a CSDT full process, we will need to modify the dossier completely to adapt it to Thai FDA submission requirements. The ASEAN Harmonization gives the guidelines, that Thai FDA follows, but structure of dossier is totally different. We suggest you to consider also a relevant timing for dossier preparation by our staff, based on the information you will provide.
For more information: mailto:[email protected]
Download PDF here:https://www.siamdevelopment.com/wp-content/uploads/2023/05/Timing-for-Thai-FDA-Medical-Device-Registration.pdf
