Navigating China’s Labeling, Ad Regulations: An Expert’s Guide

Simply translating a medical device’s instructions for use (IFU) from the original language into Chinese will likely land foreign devicemakers in the regulatory hot seat, according to Vic Zhang, director of regulatory affairs-China for Smith & Nephew’s Advanced Surgical Devices Division. In addition to the kinds of information the U.S. Food and Drug Administration requires, Chinese IFUs must include the address of the actual manufacturing site, contact information for an in-country registration agent and after-sale service provider, device registration certification number, import license number, product standard number and shelf life, explained Zhang.
International Medical Device Regulatory Monitor