Thailand Medical Device Registration Requirements

Hi everyone,

You've been so kind helping me out with all these information about Medical devices in ASEAN countries, believe me all of these is quite new for me.
There is only one little doubt with Thailand cause it is the country which reports less information compared to Singapore and Malaysia. Has any of you submitted any kind of register to Thailand? I just want to know if you followed the CSDT format as it is, cause Thailand doesn't mention any particular restriction for it.

I know I've been messing too much with that, but I really want to be confident before I start the project.
Thank you so much again for your help. Regards!!

Hi,

For Thailand, it depends on the classification of the product.

If class III, a low-risk device, only the distributor should have an operting/importing license and submit the product information(name, manufacturer, intended use,working principle, safety instructions, label, IFU) with Free Sales Certificate to your distributor. He will do submission on your behalf.
For high risk devices, there is no specified format of submission from ThaiFDA;however, you can follow CSDT format.

Hope this helps!

Regards,
Sreenu

Thanks Sreenu!!

I guess I can take advantage that I'm assembling the register for Singapore and Malaysia too, for which the CSDT format applies.
Regards!!

Hi

In addition to Sreenu's post, i request to refer the existing thread "Implantable Medical Device (Silicone Implant) Regulations for Thailand & Mexico", and you can find the details about "Thailand medical devices import requirements"

Thanks!!

I'll check it! Regards!