Special Medical Device Labeling Requirements in Thailand

L

LQ. Fanny Lozano

#1
Hi everyone!

I'm actually working on medical devices labelling with the purpose of exporting to Thailand. I have seen the general GHTF requirements for medical devices labelling but still, I really haven't find if there are any special and particular requirement in Thailand (about Language, including any special legend or anything else, for example).
Has someone submitted any medical device in Thailand yet?? Does somebody knows if everything must be written in Thai or could it be in English?

Thanks a lot for your information and your help!!

Regards :bigwave:
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#2
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 

sreenu927

Quite Involved in Discussions
#5
Dear Somasekar,

This information from the Clinivation reports for which I had the membership until last Dec. I can't put in public due to concerns from my company...I'l PM to you.

Regards,
Sreenu
 
L

LQ. Fanny Lozano

#6
Hi everyone,

Somashekar unfortunately that is the main problem I have faced all this time....there is very few (for not saying none) public information where you can support this statement about Medical devices in Thailand. I'm sharing you a link I just found yesterday which is very old (from 2001 to 2009) but there is declared that the language requirement is in Thai:

http://www.pacificbridgemedical.com/newsletter/article.php?id=22

http://www.ita.doc.gov/td/health/thailandregs.html

and

http://bic.thaiembassy.sg/node/151

But still, this isn't official information provided on FDA Thailand which is their Health Ministry, and that is why I want to confirm that this fact is current and more detailed information about labelling.

I guess that this information is very local and it hasn't been published as on some other countries...that's too bad.

Anyway, thank you Sreenu for helping out anytime you can!! You've been so helpful through this ASEAN project I've been dealing with!!

Best regards!
 
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