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.
The registration and product standard numbers must appear in the device labeling as well, he said. The latter indicates compliance with an internationally sanctioned standard.
With a huge population, growing economy, and healthcare aimed at covering 1.2 billion people, China could soon become the second-largest medical device market. But although China is a WTO member, its administrative measures are far from transparent. Many are downright variable, requiring great finesse with the cultural and political environments.
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