China Revises Device Regulations: What You Need to Know

One of the most important considerations device manufacturers will make before entering China is whether the device will be manufactured locally or not.

Deciding to manufacture abroad — either at a facility or a contract manufacturer — will require having a registration agent to be a liaison with the China Food and Drug Administration.

That agent will help with registration, regulatory compliance and postmarketing surveillance activities, said John Balzano, special counsel for law firm Covington and Burling, during a recent FDAnews webinar. Most companies will need a separate regulatory consultant as well. — Tamra Sami