FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Devicemaker Faked FDA Documents, Chinese Regulators Say

Nov. 20, 2017

Chinese regulators assessed a fine of nearly $1.3 million on the manufacturer of a nasal cleaning and irrigation device that they suspect falsified U.S. FDA marketing-clearance documents to register the product as an import.

The regulators revoked the marketing registration for the product and said its manufacturer, TechWorld, may not reapply for registration for two years.

The fine includes approximately $257,000 that represents TechWorld’s gain from marketing the device and a penalty of four times that amount.

View today's stories