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.