UDI Submission for China NMPA

Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market.  It is a potential high-growth area for many global medical device manufacturers.  So, if you’re a medical device...

EUDAMED and GUDID – What’s Changed?

The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...