In-Country Representative - Thailand

jiligan

Involved In Discussions
#1
Does anyone know if it is possible to have two medical device distributors in Thailand who are both in-country representatives or can we have only one in-country representative with multiple distributors? Thank you!
 
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Watchcat

Trusted Information Resource
#2
MAYBE SOMEONE ELSE HERE CAN AT LEAST CONFIRM MY THINKING ON THIS:

I can only work from the logic, that the fundamental purpose of requiring a foreign company to have an authorized in-country representative is to have an entity subject to local laws, because it's easier for a government to go after a naughty company under its own laws than international laws. So I can't see a government objecting to two such entities to target, should it want to pursue some kind of legal or regulatory action against your company.

Also, I don't know what the process is in Thailand. I gather you can't just pick up the phone and ask the Thai government? In that case, the easiest way to find out may be to simply make both of them in-country reps and see if anyone objects. I can't see any legal penalties in that case. I think you'd just have to pick one or the other at that point. The main issue might arise in any contractual commitments to the distributor that didn't get to be in-country representative any more.

PS And if now you are wondering why your distributors would want to be legal targets, maybe they don't understand what being an authorized rep is all about. There is a reason that a lot of US authorized reps for smaller foreign medical device companies are lawyers.
 

jiligan

Involved In Discussions
#3
MAYBE SOMEONE ELSE HERE CAN AT LEAST CONFIRM MY THINKING ON THIS:

I can only work from the logic, that the fundamental purpose of requiring a foreign company to have an authorized in-country representative is to have an entity subject to local laws, because it's easier for a government to go after a naughty company under its own laws than international laws. So I can't see a government objecting to two such entities to target, should it want to pursue some kind of legal or regulatory action against your company.

Also, I don't know what the process is in Thailand. I gather you can't just pick up the phone and ask the Thai government? In that case, the easiest way to find out may be to simply make both of them in-country reps and see if anyone objects. I can't see any legal penalties in that case. I think you'd just have to pick one or the other at that point. The main issue might arise in any contractual commitments to the distributor that didn't get to be in-country representative any more.

PS And if now you are wondering why your distributors would want to be legal targets, maybe they don't understand what being an authorized rep is all about. There is a reason that a lot of US authorized reps for smaller foreign medical device companies are lawyers.
Thank you!
 

Mikilk

Involved In Discussions
#4
Multiple distributors are allowed but you should have 1 importer/local that his details will be included in the application file by the time you register your devices.
 

maya_tanase

Starting to get Involved
#5
Hello everybody,
I've recently had the opportunity to contact the Thai FDA for a Local Representative-related issue. I thought I'd share with you their official position/answers on the matter:

Q: If the (foreign) Manufacturer appoints a local distributor to register and distribute one of their product lines, who will be the registration/license holder in this case, the Manufacturer or the distributor?
A: A local distributor will be the registration/license holder of your product. However, the local distributor will be the one who takes all the responsibility and punishment, too. So we suggest you arrange the agreement between you and local company careful

Q: Would the Manufacturer be allowed to register other product lines with different/other local distributors?
A: Yes, the registration/license holder is a local distributor separately. Depends on your agreement between you and the local distributor.

Q: Would the Manufacturer be allowed to register the same product line with different/other local distributors? (more than one, simultaneously)
A: Yes, the registration/license holder is a local distributor separately. Depends on your agreement between you and the local distributor.

Q: Would the Manufacturer be allowed to register the same product line, but under a different trade name (and code) employing the services of a different/another local distributor?
A: Yes, the registration/license holder is a local distributor separately. Depends on your agreement between you and the local distributor.
Note. The ones who register the medical device to the Thai FDA will be the registration/license holder


Q: In the event that the relationship between the Manufacturer and the local distributor (the one who initially registered the product and obtained the license) is interrupted, would the Manufacturer be allowed to sell this line that he has registered to other distributors?
A: Even the relationship between the Manufacturer and the local distributor is interrupted, the product that you're already importing to Thailand can be sold on the market. But if you want to import after your interruption, you have to register that product again. The concerns about the consent of the initial distributor depends on your agreement.

I hope it can help.
 

Watchcat

Trusted Information Resource
#8
Now I'm starting to feel a little like a go-between for two teenagers who are afraid to ask each other out. :D

I posted to the RAPS forum and got this comment, which others here might find useful:

In my view, for the last question, If the terms are not good between manufacturer and distributor/initial registrant, the manufacturer can request for an MA transfer to the other local distributor through a simple letter of authorization and continue to do the export through new MA holder/distributor rather than going for a new registration again. As you rightly mentioned it all depends on the agreement between the manufacturer and the initial distributor.

I cannot speak to the accuracy of this information. I'm just the messenger, lol.
 
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