ARTICLE SUMMARY:
China’s regulatory agency is doing more inspections at device facilities around the world, and National Medical Products Administration audits are logistically more complex than an FDA inspection. Here are survival tips from Vy Tran, who leads regulatory operations at Varian Medical Systems, which recently hosted NMPA auditors at its Palo Alto facility.
The frequency and vigor of device facility inspections from China’s National Medical Products Administration are growing, not only within China but overseas as well. No matter where you are manufacturing your devices, if you are selling in the rapidly growing Chinese market, you need to be ready for NMPA auditors to show up at your door.
