I would like to seek your guidance with regard to some of our Biomet UK hip IFUs which are currently used in Thailand and which are being updated to include the Biomet/Zimmer compatibility.
The Thai FDA registration potentially affected is:
- GBR 5701620
Could you let me know if the current registration will be impacted? If yes, what documents would you require from us?
I have little experience with regard to IFU changes in Thailand therefore your input would be most welcome.