R
Ruby2333
Hi Guys,
my company is a manufacturer of medical devices in China. We're preparing submission for FDA 510K, and there are some uncertain problems:
Does the FDA accept the testing report from other countries,or is there any Requirements for testing Report or lab qualifications ?
Any guidance is highly appreciated.
my company is a manufacturer of medical devices in China. We're preparing submission for FDA 510K, and there are some uncertain problems:
Does the FDA accept the testing report from other countries,or is there any Requirements for testing Report or lab qualifications ?
Any guidance is highly appreciated.