Hi Daun Putnam,
For APAC and other below listed Countries, it is NOT MANDATORY to have FDA clearance/approval before making a submission to the Authority. The processing time for registration may be less with the FDA or other GHTF Countries approval.
Also the documents to be submitted will be less,say for eg., instead of complete test plan and test report, with the FDA registration, may submit only the summary of the test plan and report.
In Singapore, if the product has got approval from any of the GHTF Countries, then it requires less documents and low fees and takes less time to obtain approval.
Similarly for Australia, the companies may get exemption from the TGA Inspection.
Regards,
Sreenu
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Sattu Sreenu Babu (M.S. RAC)
Life Technologies
Singapore
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Original Message:
Sent: 02-02-2012 18:34
From: Daun Putnam
Subject: Country of Origin
According to our research, the following countries require FDA approval before making a submission to them, and require a submission including FDA documents (e.g. FDA approval orders, CFG, etc.):
| Taiwan | Korea |
| China | Mexico |
| Brazil | Costa Rica |
| Argentina | Israel |
| Thailand | Russia (new regulation proposed) |
| Philippines | |
We thought this might be helpful to others who work in international markets.
We would also like to know if there are other countries that should be on this list.
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Daun Putnam
Principle RA Specialist
Houston TX
United States
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