China Will Give Advance Notice of Device GMP Inspections

Manufacturers of devices in China will be given advance notice at least five working days before investigators with the State Food and Drug Administration (SFDA) inspect their facilities for good manufacturing practices (GMPs). Site inspections generally will last two to three days, depending on the conditions at the facility, the SFDA says in its interim “Requirements for Medical Device GMP Inspection” posted on its website last month.
International Medical Device Regulatory Monitor