Oct 12, 2012

New Chinese Medical Device Labeling Requirements Set for 2013

The State Food and Drug Administration (SFDA), China’s medical device market regulator, will begin requiring all outside labeling and packaging of devices to be provided in Chinese starting in April 2013. According to the SFDA and the Regulatory Affairs Professional Society (RAPS), a recent SFDA notice sent to the agency’s provincial and municipal branches in China mandates that all outside labeling and packaging of medical devices include a version in Chinese. Failure to provide labeling and packaging text in Chinese will prevent manufacturers and sponsors from marketing their devices in China.
Sep 20, 2012

SFDA to Utilize Surprise Inspections of Medical Device Manufacturers in China

Recent regulations implemented by China’s State Food and Drug Administration (SFDA) now allow unannounced inspections...
Jul 12, 2012

SFDA releases China Provisions on Medical Devices Recalls

China’s State Food and Drug Administration (SFDA) strengthened its efforts to protect human health and safety via regulation of medical device recalls.
Jan 12, 2012

Chinese Medical Technology Market Primed for 17% Growth According to Citigroup

A new Citigroup Global Markets report on China’s medical device and technology industries expects the...
Dec 19, 2011

China Allows Clinical Trial Waivers for Some Class II Medical Devices

Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.
Aug 30, 2011

New Saudi Regulations in Effect for Medical Device Importers

Saudi Arabia’s Medical Device Interim Regulation (MDIR), which includes new documentation requirements for foreign manufacturers importing to the Saudi market, have gone into effect.
Jun 23, 2011

Device Recall Regulations Set to Take Effect in China

China’s State Food and Drug Administration (SFDA) will implement new medical device recall regulations on July 1.