The Thai Food and Drug Administration (Thai FDA) has issued new rules on classification and registration of Medical Devices and IVDs.
New Medical Device and IVDs classification
The new regulations provide for 4 classes of risk (unlike the previous 3) and they apply to both Medical Devices (DM) and in Vitro Diagnostic Medical Devices (IVD).
The following table summarises the new classification:
|Previous classification||New classification||Effective date|
|General||Class 1 – Insertion||17 March 2021|
|Notified||Class 2 – Notified |
Class 3 – Notified
15 February 2021
|Licensed||Class 4 – License|
Impact on Medical Device and IVD Registration
The documentation for the application for registration must now be submitted in two steps, with the possibility to evaluate the grouping into systems, sets, kits and families for devices of all classes. In particular the defined steps are:
- Pre-submission: at this step applicants must enter information in the system to confirm the risk class and the grouping of the device, if permitted.
- E-submission: applicants may submit partial or total electronic submission of all documentation for the device registration.
Ultimately, more documentation is required, the delivery times of the registration process are longer and the fees for submission (“application fee” and “license fee”) are higher. It should be added that the next 31 October new requirements for the labelling of Medical Deviceswill enter into force.