Devicemaker Faked FDA Documents, Chinese Regulators Say
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.
Device Sales May Continue If Notified Body Doesn’t, French Say
Sellers of medical devices in France can continue marketing their products after the entity that certifies them ceases operations until a valid certificate expires or for a year after the cessation, whichever comes first, French regulators said.
In the EU, some notified bodies have shut down or had their power to certify canceled by authorities. In such cases, device manufacturers should seek certification from a still-extant notified body as soon as possible, the regulators said.
The guidelines were agreed to at an October 2016 meeting of the EU Competent Authorities for Medical Devices.
First Proton Beam System Approved in Brazil
In a first for Brazil, medical device regulators approved a proton beam cancer treatment system.
The approved device is manufactured by Varian Medical Systems, headquartered in Palo Alto, California. The device can be applied to treatment of cancers of the head, neck, liver, lung and gastrointestinal system, regulators said.