Pre-Clinical Studies for Medical Devices in Thailand

  • Thread starter LQ. Fanny Lozano
  • Start date
L

LQ. Fanny Lozano

#1
Hi everyone!

Here bringing 2 new doubts about Medical Devices registration in Thailand:

1. Due that there is quite few information about Medical devices requirements in Thailand, I want to know if a "Certificate of Exportation" could be accepted instead of a Free Sale Certificate.

2.In the CSDT format it is mentioned that full evaluation medical devices must present (in detailed form) Pre-clinical studies where the materials and the final product are tested. Then, is it obligatory for every medical device?

I´ll be very grateful for any information concerning to this case!!

Thank you all!! :truce:
 
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sreenu927

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#2
Hi

1. Due that there is quite few information about Medical devices requirements in Thailand, I want to know if a "Certificate of Exportation" could be accepted instead of a Free Sale Certificate.

Check with your distributor. From my view, it should be fine, as long as you show proof that the product has been sold in the Country of Origin with out any problems.

2.In the CSDT format it is mentioned that full evaluation medical devices must present (in detailed form) Pre-clinical studies where the materials and the final product are tested. Then, is it obligatory for every medical device?

If you have pre-clinical studies or bench studies done, then you submit the plan and report. Else, submit the verification and validation test plans and test reports. This will do. However, it depends on the classification of your device in Thailand. If it is Class I, then you need all these, if Class II, only summary of the test plan and report will do. If Class III, don;t need CSDT.

Regards,
Sreenu
 
#3
I am not sure if someone needs to maintain it. Here is my update answer to this question.

1. Due that there is quite few information about Medical devices requirements in Thailand, I want to know if a "Certificate of Exportation" could be accepted instead of a Free Sale Certificate.

--> I do not think they accept Certificate of Exportation.

2.In the CSDT format it is mentioned that full evaluation medical devices must present (in detailed form) Pre-clinical studies where the materials and the final product are tested. Then, is it obligatory for every medical device?

--> No. For Class I, importer only need to register in the FDA e-listing only. There is no need for Clinical Evaluation. In addtional, if your product is sterile class A (class I in MDD), you may need to prepare some sterile validation and other document in extra, too. Only Class B, C, D (IIa, IIb, III in MDD), you will need to find literature to support your evaluation. Only class D and implant product, you need to do Clinical Investigation.

Cheers,
Pete
 
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